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Medical Forum / Diseases and Disorders / Prostate Cancer / July 2005Gen-immune therapy against prostate cancer
Hi, Is there anything known or published in the English language about this research project? With help of two vaccins (CG1940 and CG8711) and anti-bodies should the cancer be cleared by the imune system itself. I am invited for a take-in consult and like to tell some US-friends aboud this opportunity, but it's horrible to understand so impossible to translate. Here below is the Dutch text from the press info. Oh yes, please, I know, it is not a cure and I'm not cancelling my funeral yet. Douwe Gen-immunotherapie therapie tegen prostaatkanker ingezet Het VU Medisch centrum (Amsterdam - Nederland) zet met een fase I/II studie een nieuwe vorm van gen-immunotherapie in tegen uitgezaaide prostaattumoren. Met behulp van twee vaccins en een antilichaam moet de prostaatkanker door het immuunsysteem geklaard worden. De vaccins, CG1940 en CG8711, zijn gemaakt uit twee prostaatkankercellijnen die genetisch zo veranderd zijn dat ze Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) aanmaken, een groeifactor voor witte bloedcellen. GM-CSF trekt cellen aan die tumoreiwitten aanbieden aan T- lymfocyten. Deze T-lymfocyten zijn de werkpaarden bij het opruimen van de tumor. De prostaatkankercellen in het vaccin worden met een hoge dosis bestraald, zodat zeker is dat zij niet gaan groeien als ze ingespoten zijn bij de patiënt. Als de vaccins in de huid zijn ingespoten, wordt per infuus het antilichaam MDX-010 toegediend. MDX-010 blokkeert CTLA-4, een eiwit dat de afweerreactie afremt. MDX-010 zorgt ervoor dat de rem op de immuunreactie geblokkeerd wordt en dat het afweerproces op gang blijft. hi douwe - your wish is my command. seems like they are making a vaccine from prostate cancer cells...... hope this info helps........ TRIAL NAME:Phase 3 Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients with Metastatic Hormone-Refractory Prostate Cancer who are Chemotherapy-NaïveTRIAL #:G-0029 OBJECTIVES To compare the duration of survival between GVAX® vaccine for prostate cancer and chemotherapy treatment arms ELIGIBILITY Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostateMetastatic prostate cancer deemed to be unresponsive or refractory to hormone therapyDetectable metastasesTwo consecutive rising PSA values obtained at least 4-6 weeks after discontinuation of antiandrogen therapy.ECOG performance status 0-2Any Gleason scoreNo prior treatment with chemotherapyNo prior treatment with gene therapyNo prior immunotherapyNo significant cancer related pain TREATMENT Patients will be enrolled in one of two treatment arms. Patients randomized to Arm 1 will receive an initial vaccination of GVAX® vaccine for prostate cancer followed 14 days later by boost vaccinations every 14 days for 12 treatments for a total of 13 vaccinations (24 weeks of treatment). Patients randomized to Arm 2 will receive Taxotere® (docetaxel) and prednisone every 21 days for up to 9 cycles (24 weeks of treatment).The duration of the study treatment is approximately 6 months. Additional visits at 6 and 12 months will occur following treatment. Patients will then be followed for the duration of their life for survival/long-term follow-up. ENROLLMENT INFORMATION Select major eligibility criteria are listed above. For more information call 1.866.679.4904. You may also check clinicaltrials.gov for a current list of locations with open sites. Continue to check this website as trial locations are being added regularly. ========= unforunately, webtv doesn't support PDF files, but i can post where you are get the information.... -------------------------- In order to view and print PDF files, you need the latest version of the free Adobe Acrobat ReaderTM. Click on the link below to download and install the version for your computer. If you experience any problem accessing a Summary Notification, please write to gmoinfo-comments@jrc.it Notification numberStatePublicationName of the Institutes or CompaniesProject titleFinal reportB/ES/05/26 B/NL/03/08 Netherlands 04/05/2004 VU Medical Center A phase 1 dose escalation trial of MDX- 010 in combination with CG1940 and CG8711 in patients with metastatic HRPC ===========this trial study is still open and taking patients. below is the listing by state....... ------ GVAX® Prostate Cancer Vaccine Vs Docetaxel and Prednisone in Patients with Metastatic Hormone-Refractory Prostate Cancer This study is currently recruiting patients. Sponsored by:Cell Genesys Information provided by:Cell Genesys Purpose The purpose of this study is to compare the duration of survival between GVAX® prostate cancer vaccine and chemotherapy treatment in patients with prostate cancer who no longer respond to hormone therapy, who have documented metastases, and who have not been treated with chemotherapy in the past. Condition InterventionPhaseProstate Cancer Vaccine: Immunotherapy with allogeneic prostate vaccine Drug: Chemotherapy (Taxotere and prednisone) Phase III MedlinePlus related topics: Prostate Cancer Study Type: Interventional Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study Official Title: A Phase III Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients with Metastatic Hormone-Refractory Prostate Cancer Who Are Chemotherapy-Naïve Further Study Details: Expected Total Enrollment: 600 Study start: July 2004 Eligibility Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Male Criteria Inclusion Criteria: Confirmed diagnosis of or clinical history consistent with adenocarcinoma of the prostate Metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy Detectable metastases Any Gleason score ECOG performance status 0-2 Exclusion Criteria: Prior treatment with chemotherapy Prior Immunotherapy Prior treatment with gene therapy Significant cancer related pain Location and Contact Information Please refer to this study by ClinicalTrials.gov identifier NCT00089856 MEDFONE Call Center 1-866-679-4904 Alabama Central Alabama Oncology, LLC, Alabaster, Alabama, 35007, United States; Recruiting Betty Veitch, RN 205-824-3635 Elizabeth A. Lowenthal, DO 205-664-4051 Elizabeth A. Lowenthal, DO, Principal Investigator Arizona Palo Verde Hematology/Oncology, Glendale, Arizona, 85304, United States; Recruiting Gera Barnard 602-978-6255 Ext. 39 Amol Rakkar, MD 602-978-6255 Amol Rakkar, MD, Principal Investigator Arizona Clinical Research Center, Inc., Tucson, Arizona, 85715, United States; Recruiting Jarret Schonbrun 520-290-2510 Manuel Modiano, MD 520-290-2510 Manuel Modiano, MD, Principal Investigator Mayo Clinic Scottsdale, Scottsdale, Arizona, 85259, United States; Recruiting Nicolas Pirooz 480-301-4890 Thomas Hogan, MD 480-301-8335 Thomas Hogan, MD, Principal Investigator Arkansas Arkansas Cancer Research Center, Little Rock, Arkansas, 72205, United States; Recruiting Lynne Vinson 501-257-6846 Manoj Agarwal, MD 501-686-8274 Manoj Agarwal, MD, Principal Investigator California Providence St-Joseph Medical Center, Burbank, California, 91505, United States; Recruiting Evelyn Dizon 818-847-3218 Raul Mena, MD 818-840-0921 Raul Mena, MD, Principal Investigator Sharp Healthcare, San Diego, California, 92123, United States; Recruiting Cathy Wood 858-939-5062 Charles Redfern, M.D. 858- 637-7888 Charles Redfern, M.D., Principal Investigator Compassionate Cancer Care Medical Group, Inc., Fountain Valley/Corona, California, 92708, United States; Recruiting Lorrayne Skeens (Fountain Valley) 714-210-2300 Mary Nashed (Corona) 951-371-2411 Haresh S Jhangiani, MD, Principal Investigator Cancer & Blood Institute Medical Group at the Lucy Curci Cancer Center, Rancho Mirage, California, 92270, United States; Recruiting Susan Sagle 760-568-4461 Robert Lemon, MD 760-568-4461 Robert Lemon, MD, Principal Investigator Orange County Regional Cancer Center, Fountain Valley, California, 92708, United States; Recruiting Debbie Fridman 714-751-2600 Ext. 342 Cari Nelson 714-751-2600 Ext. 335 Glen R Justice, MD, Principal Investigator Cancer Research & Treatment Center, Soquel, California, 95073, United States; Recruiting Cecilia Rivas 831-462-8750 J. Talisman Pomeroy IV, MD 831-462-8750 J. Talisman Pomeroy IV, MD, Principal Investigator California Cancer Care, Greenbrae, California, 94904, United States; Recruiting Jaime Chang 415-925-5040 Peter D. Eisenberg, MD 415-925-5000 Peter D. Eisenberg, MD, Principal Investigator Kenmar Research Institute, LLC, Los Angeles, California, 90057, United States; Recruiting Viet Pham 213-989-1888 Mayank Vakil, MD 213-484-6474 Mayank Vakil, MD, Principal Investigator San Diego Cancer Center, Vista, California, 92081, United States; Recruiting Christine Defrancisco 760-598-1700 Alberto Bessudo 760-598-1700 Alberto Bessudo, MD, Principal Investigator Scripps Cancer Center, San Diego, California, 92121, United States; Recruiting Amy Nance 858-554-9253 Jorge Nieva, MD 858-554-5269 Jorge Nieva, MD, Principal Investigator Center for Urological Research, La Mesa, California, 91942, United States; Recruiting Susie Amaya 619-460-0595 Mohamed Bidair, MD 619-460-0595 Mohamed Bidair, MD, Principal Investigator Colorado Cancer Center of Colorado Springs, Colorado Springs, Colorado, 80907, United States; Recruiting Kaye Whitt, RN, OCN 719-444-4807 Daniel Tell, MD 719-444-4807 Daniel Tell, MD, Principal Investigator Connecticut Urology Center of Grove Hill, New Britain, Connecticut, 06052-1395, United States; Recruiting Suzanne Collins 860-826-4453 Rafael Wurzel, MD 860-826-4453 Rafael Wurzel, MD, Principal Investigator Florida Oncology-Hematology Group of South Florida, Miami, Florida, 33176, United States; Recruiting Julie Reed 305-728-1882 Leonard Kalman, MD 305-595-2141 Leonard Kalman, MD, Principal Investigator Cancer Centers of Florida, Ocoee, Florida, 34711, United States; Recruiting Lynne Hogue 407-658-9532 Barry Berman, MD 407-297-6435 Barry Berman, MD, Principal Investigator Pasco Hernando Oncology, New Port Richey, Florida, 34652, United States; Recruiting Eve Crosariol, RN 727-842-2795 Kapisthalam Kumar, MD 727-842-2795 Kapisthalam Kumar, MD, Principal Investigator Tampa Bay Urology, Tampa, Florida, 33607, United States; Recruiting Linda Haynie 813-872-7881 Mark Swierzewski, MD 813-875-5855 Mark Swierzewski, MD, Principal Investigator Hematology Oncology Associates of the Treasure Coast, Port St. Lucie, Florida, 34952, United States; Recruiting Christine Baker 772-408-5159 Michael Wertheim, MD 772-335-5666 Michael Wertheim, MD, Principal Investigator Urology Consultants, Clearwater, Florida, 33761, United States; Recruiting Phyllis Wattleworth 727-797-3281 Mark Zachary, MD 727-724-9551 James M Zachary, MD, Principal Investigator Michael and Dianne Bienes Comprehensive Cancer Center, Holy Cross Hospital, Fort Lauderdale, Florida, 33308, United States; Recruiting Carol Brudenell 954-267-7704 Melanie White 954-267-7705 Leonard Seigel, MD, Principal Investigator The Center for Hematology-Oncology, Boca Raton, Florida, 33486, United States; Recruiting Dolores Preiser, RN, OCN 561-416-8869 Ext. 262 Alan Koletsky, MD 561-416-8869 Ext. 262 Alan Koletsky, MD, Principal Investigator Georgia Central Georgia Hematology & Oncology Associates, P.C., Macon, Georgia, 31201, United States; Recruiting Joanne Kerr 478-743-7068 Frederick Schnell, M.D. 478-743-7068 Frederick Schnell, M.D., Principal Investigator Georgia Cancer Specialists, Atlanta, Georgia, 30342, United States; Recruiting James Gilmore 770-496-9428 Mansoor Saleh, MD 770-496-9403 Mansoor Saleh, MD, Principal Investigator Emory University - Winship Cancer Institute, Atlanta, Georgia, 30322, United States; Recruiting Janell Bowersox 404-778-5959 Vasily Assikis, MD 404-778-2206 Vasily Assikis, MD, Principal Investigator Hawaii Straub Clinic & Hospital, Honolulu, Hawaii, 96813, United States; Recruiting Fe Evans 808-522-4536 Ian Okazaki, MD 808-522-4333 Ian Okazaki, MD, Principal Investigator Idaho North Idaho Cancer Center, Coeur D Alene, Idaho, 83814, United States; Recruiting Carla Taylor 208-666-3800 Haluk Tezcan, MD 208-666-3800 Haluk Tezcan, MD, Principal Investigator Illinois Midwest Cancer Research Group, Skokie, Illinois, 60077, United States; Recruiting Sharon Goldman 847-673-1999 Ira Oliff, MD 847-673-1999 Ira Oliff, MD, Principal Investigator Indiana Welborn Clinic Research Center, Evansville, Indiana, 47713, United States; Recruiting Missy Goffinet 812-492-5011 Paul Siami, MD 812-426-9275 Paul Siami, MD, Principal Investigator Fort Wayne Medical Oncology/Hematology Inc., Fort Wayne, Indiana, 46815, United States; Recruiting Leslie Edgar Edgar, NP 260-484-9660 Ext. 230 Charles Whalen, MD 260-484-8830 Charles Whalen, MD, Principal Investigator Iowa Cedar Valley Medical Specialists, Waterloo, Iowa, 50702, United States; Recruiting Kim Maxfield 319-272-2700 Joginder Singh, MD 319-272-2700 Joginder Singh, MD, Principal Investigator Louisiana Lake Charles Medical and Surgical Clinic, Lake Charles, Louisiana, 70601, United States; Recruiting Myra Thomas 337-312-8205 Mohammad Khan, M.D. 337-312-8204 Mohammad Khan, M.D., Principal Investigator Louisiana Oncology Associates, Lafayette, Louisiana, 70506, United States; Recruiting Nancy Lormand 337-235-7898 David Rinaldi, MD 337-235-7898 David Rinaldi, MD, Principal Investigator Maryland Frederick Memorial Hospital Regional Cancer Therapy Center, Frederick, Maryland, 21701, United States; Recruiting Patricia Shank 301-668-7043 Gregory Rausch, MD 301-662-8477 Gregory Rausch, MD, Principal Investigator Johns Hopkins Oncology Center, Baltimore, Maryland, 21231, United States; Recruiting Sandra Schaefer, RN, BSN, OCN 410-614-5241 Irena Tartakovsky, CCRC 410-614-2514 Charles Drake, MD, Principal Investigator Michigan William Beaumont Hospital, Cancer Clinical Trials Office, Royal Oak, Michigan, 48073-6706, United States; Recruiting Ingrid Tibbits 248-551-6935 David Decker, MD 248-551-6900 David Decker, MD, Principal Investigator West Michigan Regional Cancer and Blood Center, Free Soil, Michigan, 49411, United States; Recruiting Joe Johnson 231-757-1260 A. Soliman Behairy, MD 231-757-1260 A. Soliman Behairy, MD, Principal Investigator Newland Medical Associates, P.C., Southfield, Michigan, 48075, United States; Recruiting Janine Haubenreich 248-552-0620 Anibal Drelichman, MD 248-552-0620 Anibal Drelichman, MD, Principal Investigator Missouri St. Joseph Oncology, Inc., St. Joseph, Missouri, 64507, United States; Recruiting Bob Moore 816-271-1032 Robert Weigand, MD 816-271-1301 Robert Weigand, MD, Principal Investigator Hematology Oncology Consultants, Inc., St. Louis, Missouri, 63136, United States; Recruiting Helen Mullner 314-355-5597 Ext. 31 Mark Woodson, MD 314-355-5597 Mark Woodson, MD, Principal Investigator Montana Hematology/Oncology Centers of the Northern Rockies, P.C., Billings, Montana, 59101, United States; Recruiting Celia Fisher 406-238-6962 Patrick Cobb, MD 406-238-6290 Patrick Cobb, MD, Principal Investigator Nebraska University of Nebraska Medical Center, Omaha, Nebraska, 68198-7680, United States; Recruiting Jayne Siebler 402-559-8711 Ralph Hauke, MD 402-559-6210 Ralph Hauke, MD, Principal Investigator New Hampshire Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, 03756, United States; Recruiting Denise Machado-Rogers 603-650-7859 Marc Ernstoff, MD 603-650-5534 Marc Ernstoff, MD, Principal Investigator New Jersey Hematology-Oncology Associates of Northern New Jersey, Morristown, New Jersey, 07962, United States; Recruiting Serena Schmitz 973-538-5210 Ext. 2338 Stacey Leibowitz, MD 973-538-5210 Stacey Leibowitz, MD, Principal Investigator Summit Medical Group/Overlook Oncology Center, Summit, New Jersey, 07901, United States; Recruiting Nerely Cruz 908-273-4300 Ext. 5131 Michael Wax, MD 908-219-3080 Michael Wax, MD, Principal Investigator New York SUNY Upstate Medical University, Syracuse, New York, 13210, United States; Recruiting Diane Gould 315-464-8235 Bernard Poiesz, MD 315-464-5476 Bernard Poiesz, MD, Principal Investigator Jacobi Medical Center, Division of Hematology/Oncology, Bronx, New York, 10461, United States; Recruiting Bola Omotosho 718-918-4581 Manuel Macapinlac, MD 718-918-4581 Manuel Macapinlac, MD, Principal Investigator North Carolina Northwestern Carolina Hematology Oncology, PA, Hickory, North Carolina, 28602, United States; Recruiting Sylvia McLendon 828-324-9550 Ext. 222 Richard Orlowski, MD 828-324-9550 Richard Orlowski, MD, Principal Investigator Presbyterian Hospital/ Center for Cancer Research, Charlotte, North Carolina, 28233, United States; Recruiting Lori Lipocky, RN, OCN 704-384-8920 Neil West, RN 704-384-9429 Richard B. Reiling, MD, Principal Investigator North Dakota Dakota Cancer Institute, Fargo, North Dakota, 58103, United States; Recruiting Pat Reiser 701-232-2388 Kaushik Sen, MD 701-364-8910 Kaushik Sen, MD, Principal Investigator Medcenter One Cancer Care, Bismarck, North Dakota, 58505, United States; Recruiting Laurie Holverson 701-250-8416 S. Maynard Bronstein, MD 701-323-5741 S. Maynard Bronstein, MD, Principal Investigator Ohio Gabrail Cancer Center, Canton, Ohio, 44718, United States; Recruiting Carrie Smith 330-492-3345 Ext. 208 Nashat Gabrail, MD 330-492-3345 Nashat Gabrail, MD, Principal Investigator University of Cincinnati Medical Center, Cincinnati, Ohio, 45267-0501, United States; Recruiting Cheryl Sizemore, RN 513-584-7614 Leslie Oleksowicz, MD 513-584-3806 Leslie Oleksowicz, MD, Principal Investigator Oklahoma University of Oklahoma, Oklahoma City, Oklahoma, 73104, United States; Recruiting Ralph Mysel 405-271-6966 Ext. 46186 Daniel Culkin, MD 405-271-8156 Daniel Culkin, MD, Principal Investigator Oregon Providence Portland Medical Center, Portland, Oregon, 97213, United States; Recruiting Chrislyn DiNuova 503-215-6805 Brendan Curti, MD 503-215-5696 Brendan Curti, MD, Principal Investigator Pennsylvania Medical Oncology Associates, Kingston, Pennsylvania, 18704, United States; Recruiting Angela Luongo 570-331-8105 Bruce Saidman, MD 570-262-3894 Bruce Saidman, MD, Principal Investigator Urological Associates of Lancaster, Lancaster, Pennsylvania, 17604, United States; Recruiting Dorie Rodriguez 717-431-2285 Paul Sieber, MD 717-431-2285 Paul Sieber, MD, Principal Investigator University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, 15232, United States; Recruiting Lois Brown 412-235-1023 Gurkamal Chatta, MD 412-648-6466 Gurkamal Chatta, MD, Principal Investigator Lancaster Cancer Center, Ltd, Lancaster, Pennsylvania, 17601, United States; Recruiting Melanie Rice 717-291-1313 H. Peter DeGreen, MD 717-291-1313 H. Peter DeGreen, MD, Principal Investigator Rhode Island University Urological Research Institute, Providence, Rhode Island, 02904, United States; Recruiting Betsy Parrott 401-276-2007 Ext. 1257 Barry Stein, MD 401-272-7799 Barry Stein, MD, Principal Investigator South Carolina Charleston Hematology Oncology, Charleston, South Carolina, 29403, United States; Recruiting Deborah McNeal 843-577-6957 George Geils, MD 843-577-6957 George Geils, MD, Principal Investigator Tennessee The West Clinic, Memphis, Tennessee, 38120, United States; Recruiting Sherry Hodges, RN 901-683-0055 Ext. 1049 Brad Somer, ME 901-683-0055 Brad Somer, MD, Principal Investigator Memorial Health Care System, Chattanooga, Tennessee, 37404, United States; Recruiting Suzanne Stephens 423-495-8975 Penny Skelton 423-495-4775 Edward R. Arrowsmith, MD, Principal Investigator Mid-South Cancer Center, Memphis, Tennessee, 38119, United States; Recruiting Jonathan Davis 901-763-0446 Kirby Smith, MD 901-763-0446 Kirby Smith, MD, Principal Investigator Texas The Methodist Hospital, Houston, Texas, 77030, United States; Recruiting Pat Brinegar 713-363-7987 Alejandro Preti, MD 713-795-0933 Alejandro Preti, MD, Principal Investigator Cancer Specialists of South Texas, Corpus Christi, Texas, 78412, United States; Recruiting Katrina Powell 361-993-3456 Ext. 140 Albert Wood, MD 361-993-3456 Albert Wood, MD, Principal Investigator Mary Crowley Medical Research Center, Dallas, Texas, 75246, United States; Recruiting Candace Branom, RN 214-370-1857 John Nemunaitis, MD 214-370-1870 John Nemunaitis, MD, Principal Investigator Tyler Cancer Center, Tyler, Texas, 75702, United States; Recruiting Linda Dunklin, RN 903-579-9800 Karen Poe, RN 903-579-9869 Donald Richards, MD, Principal Investigator Harrington Cancer Center, Amarillo, Texas, 79106, United States; Recruiting Rose Ingerson, RN 806-354-5875 Ext. 231 Leonard Forero, MD 806-354-5875 Leonard Forero, MD, Principal Investigator Urology Clinic of North Texas, Dallas, Texas, 75231, United States; Recruiting Tracy Williams Reed 214-345-4121 James S. Cochran, MD 214-691-1902 James S. Cochran, MD, Principal Investigator Center for Oncology Research and Treatment, Dallas, Texas, 75230, United States; Recruiting Cathy Teel, RN 972-566-5588 Barry Mirtsching, MD 972-566-8153 Barry Mirtsching, MD, Principal Investigator Virginia Virginia Oncology Associates, Norfolk, Virginia, 23502, United States; Recruiting Ora Mae Jackson, RN, OCN 757-459-9250 Paul R Conkling, MD 757-873-9833 Paul R Conkling, MD, Principal Investigator Washington Yakima Regional Cancer Care Center, Yakima, Washington, 98902, United States; Recruiting Beth S Parker 509-225-2448 William Von Stubbe 509-575-7671 William Von Stubbe, MD, Principal Investigator Virginia Mason Medical Center Urology, Seattle, Washington, 98101, United States; Recruiting Kathryn Dahl 206-341-0578 John Corman, MD 206-625-7373 Ext. 63348 John Corman, MD, Principal Investigator More Information Study ID Numbers: G-0029; (VITAL-1) Record last reviewed: July 2005 Last Updated: July 25, 2005 Record first received: August 16, 2004 ClinicalTrials.gov Identifier: NCT00089856 Health Authority: United States: Food and Drug Administration ClinicalTrials.gov processed this record on 2005-07-28 knowledge is power - growing old is mandatory - growing wise is optional "Many more men die with prostate cancer than of it. Growing old is invariably fatal. Prostate cancer is only sometimes so." http://community.webtv.net/PALMER_ENT/doc "c palmer" <PALMER_ENT@webtv.net> ... > hi douwe - your wish is my command. > seems like they are making a vaccine from prostate cancer cells...... > hope this info helps........ > TRIAL NAME:Phase 3 Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients with Metastatic Hormone-Refractory Prostate Cancer who are Chemotherapy-NaïveTRIAL #:G-0029 ========== > unforunately, webtv doesn't support PDF files, but i can post where you are get the information.... -------------------------- B/NL/03/08 Netherlands 04/05/2004 VU Medical Center A phase 1 dose escalation trial of MDX- 010 in combination with CG1940 and CG8711 in patients with metastatic HRPC ------ Thank you Curtis, very fast and to the point. Please write down the URL for the PDF-file, I will download myself. As you can see, the last line is the trial I do hope to participate in. Because #1 and #2 are different, it could insinuate problems not true. Here, in VUM-Amsterdam 45 patients will participate, all younger than 80 years, have a spread Pc, a PSA above 5 (mine was 475), insensative for hormone treatment (this is the questionmark for me, what do they mean with this) and have not had a radiation therapy. rgds Douwe (e-mail is real) ... > Here, in VUM-Amsterdam 45 patients will participate, all younger than 80 > years, have a spread Pc, a PSA above 5 (mine was 475), insensative for > hormone treatment (this is the questionmark for me, what do they mean > with this) and have not had a radiation therapy. > ... Insensitive for hormone treatment, or "hormone refractory", means that you've already had hormone therapy but your PSA is still rising. The idea is that they don't give experimental treatments to people who might be helped by conventional treatment. You might also look at the phenoxodiol trials. I don't know if there are any in Holland, but the drug looked promising in its first trial of 16 people. Best of luck. Alan > ... > > Here, in VUM-Amsterdam 45 patients will participate, all younger than 80 [quoted text clipped - 16 lines] > > Alan Thank you Alan. Don't understand in full what this means (http://www.marshalledwardsinc.com/index.cfm?section=03&subsec=0303) but I am in a situation "no money is spend on me". I'm able to write this without any sacasm, was about 6 years late with some fysical complains. I even don't know if my PSA is rising or how high it is. All the bones below the belly button are with pain and inside the body several functions are eh... not willing to work as they should :) But I cope with a smile. I don't believe this Gen-Immune therapy is going to make me better. Maybe it stops the cancer, so I'll live longer, but if that's going to be a blessing yes or no is un-sure. So we have to wait and see, like any body else, I think. Regards Douwe > Thank you Alan. Don't understand in full what this means > (http://www.marshalledwardsinc.com/index.cfm?section=03&subsec=0303) It's complicated. If I understand it correctly, they're saying that there is a metabolic pathway in the body, a "chain" of chemical reactions, ending a pair of naturally occurring chemicals that block the immune system from killing cancer cells. In cancer patients, these two chemicals occur in greater quantities than they should, keeping the immune system from working on the cancer. Phenoxodiol is thought to act early on in the chain of reactions to prevent these two chemicals from being overproduced - hence helping the immune system fight the cancer. My interpretation of it is that phenoxodiol won't cure cancer, but it might help the body fight against it. > but > I am in a situation "no money is spend on me". I'm able to write this > without any sacasm, was about 6 years late with some fysical complains. I assume you have already had hormone therapy. If you have not yet had hormone therapy, you should start it immediately! It may or may not work, but it often does work. It won't cure the cancer, but it might kill off a lot of it, reduce your pain, and lengthen your life. > I even don't know if my PSA is rising or how high it is. All the bones > below the belly button are with pain and inside the body several [quoted text clipped - 6 lines] > Regards > Douwe You have a good attitude. I hope that you can get some treatment to suppress your cancer, and good treatment for your pain. And I hope that the time left to you (and to all of us) is worth living. Regards, Alan > Is there anything known or published in the English language about this > research project? With help of two vaccins (CG1940 and CG8711) and [quoted text clipped - 28 lines] > afremt. MDX-010 zorgt ervoor dat de rem op de immuunreactie geblokkeerd > wordt en dat het afweerproces op gang blijft. (CG1940 & CG8711) is GVAX® http://www.clinicaltrials.gov/ct/show/NCT00122005?order=2 http://www.clinicaltrials.gov/ct/show/NCT00089856?order=1 There's 2 clinical trials. If you type GVAX into the search box and include completed trials, you'll find more here http://www.clinicaltrials.gov/ J "J" <connectivity@example.net> wrote... > (CG1940 & CG8711) is GVAX® > http://www.clinicaltrials.gov/ct/show/NCT00122005?order=2 [quoted text clipped - 5 lines] > http://www.clinicaltrials.gov/ > J Thank you very much, J, for your input. It is enough to point my friends to :) Regards Douwe GVAX® vaccine for prostate cancer is a non patient-specific GVAX® product currently in Phase 3 clinical development for patients with advanced-stage, hormone-refractory prostate cancer. The vaccine is comprised of two prostate cancer cell lines that have been genetically modified to secrete granulocyte-macrophage colony stimulating factor (GM-CSF), a hormone which plays a key role in stimulating the body's immune response to vaccines, and then irradiated for safety. GVAX® vaccine for prostate cancer is an off-the-shelf product designed to stimulate a systemic immune response against the patient's prostate cancer, destroying prostate cancer cells that persist or recur following surgery, hormone or radiation therapy. The vaccine has demonstrated a favorable safety profile in each trial it has been evaluated in to date. In July 2004, Cell Genesys launched the first of two Phase 3 trials of GVAX® vaccine for prostate cancer in metastatic hormone-refractory prostate cancer. The patients being evaluated must have radiologic evidence of metastatic disease and cannot have received prior chemotherapy. Both trials will be conducted at multiple centers across North America and Europe and will enroll patients with all levels of Gleason scores (a measure of the aggressiveness of prostate cancer) including high-risk patients and will also include patients with non-skeletal sites of metastatic diseases. VITAL-1 (Vaccine ImmunoTherapy with Allogeneic prostate cancer cell Lines) is enrolling approximately 600 patients who are asymptomatic with respect to cancer-related pain and will compare GVAX® vaccine to Taxotere® chemotherapy. Patients who are randomized to receive GVAX® vaccine for prostate cancer will receive intradermal injections every two weeks for a period of up to six months. The trial is designed to demonstrate superiority in the duration of survival, which is the primary endpoint of the study. Cell Genesys received a Special Protocol Assessment (SPA) from the Food and Drug Administration (FDA) for the VITAL-1 trial which provided FDA confirmation that the trial design would adequately support a product registration application. The second trial, referred to as VITAL-2, which began in July 2005, will compare GVAX® vaccine plus chemotherapy to chemotherapy alone. This trial is also designed to demonstrate superiority in the duration of survival for the GVAX® vaccine plus chemotherapy arm. Cell Genesys also received a SPA from the FDA for the VITAL-2 trial. The company is currently manufacturing GVAX® vaccine for prostate cancer for Phase 3 trials in its bioreactor manufacturing facility in Hayward, California, a facility that is also capable of producing the product during its initial commercialization. Cell Genesys has previously conducted two Phase 2 trials of GVAX® vaccine for cancer in patients with advanced prostate cancer.At the Annual Meeting of the American Society of Clinical Oncology (ASCO) held last month, Cell Genesys reported additional promising results from a second Phase 2 trial of GVAX® vaccine for cancer in patients with metastatic hormone refactory prostate cancer (metastatic HRPC). The results for the 22 patients who received the highest dose - the dosing regimen comparable to that being employed in the company's Phase 3 trial - indicate that the median survival has not been reached and the final median survival will be no less than 24.1 months based on the current median follow-up time for these patients. Previously reported findings from the company's first Phase 2 trial of GVAX® vaccine for prostate cancer indicated an overall median survival of 26.2 months. The median survival results from both Phase 2 trials compare favorably to the recently reported median survival of 18.9 months for hormone-refractory metastatic prostate cancer patients treated with Taxotere® plus prednisone, the current standard of care. (The data referenced in the preceding paragraphs represent the most recently announced data pertaining to this program.) Information About GVAX® Prostate Cancer Vaccine Clinical Trials Currently Under Way: •G-0029: Phase 3 Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Patients with Metastatic Hormone-Refractory Prostate Cancer who are Chemotherapy-Naïve•G-0034: Phase 3 Randomized, Open-Label Study of CG1940 and CG8711 Versus Docetaxel and Prednisone in Taxane Naïve Patients with Metastatic Hormone-Refractory Prostate Cancer With Pain knowledge is power - growing old is mandatory - growing wise is optional "Many more men die with prostate cancer than of it. Growing old is invariably fatal. Prostate cancer is only sometimes so." http://community.webtv.net/PALMER_ENT/doc "c palmer" <PALMER_ENT@webtv.net> ... VITAL-1 (Vaccine ImmunoTherapy with Allogeneic prostate cancer cell Lines) is enrolling approximately 600 patients who are asymptomatic with respect to cancer-related pain and will compare GVAX® vaccine to Taxotere® chemotherapy. Patients who are randomized to receive GVAX® vaccine for prostate cancer will receive intradermal injections every two weeks for a period of up to six months. The trial is designed to demonstrate superiority in the duration of survival, which is the primary endpoint of the study. Cell Genesys received a Special Protocol Assessment (SPA) from the Food and Drug Administration (FDA) for the VITAL-1 trial which provided FDA confirmation that the trial design would adequately support a product registration application. The second trial, referred to as VITAL-2, which began in July 2005, will compare GVAX® vaccine plus chemotherapy to chemotherapy alone. This trial is also designed to demonstrate superiority in the duration of survival for the GVAX® vaccine plus chemotherapy arm. Cell Genesys also received a SPA from the FDA for the VITAL-2 trial. The company is currently manufacturing GVAX® vaccine for prostate cancer for Phase 3 trials in its bioreactor manufacturing facility in Hayward, California, a facility that is also capable of producing the product during its initial commercialization. ---------- This is not the road I'd like to walk, Curtis. It is not Gen-Immuno therapy Tanks Douwe > > Is there anything known or published in the English language about this > > research project? With help of two vaccins (CG1940 and CG8711) and [quoted text clipped - 38 lines] > http://www.clinicaltrials.gov/ > J Hi, In the Amsterdam trial they are using MDX-010 together with GVAX. As far as I know it's the only trial worldwide testing this mix and I couldn't find anything about this mix in the trial list. Did I miss something? Kind regards, Gert "Gert van der Kooij" <gert@invalid.nl> wrote... Hi, In the Amsterdam trial they are using MDX-010 together with GVAX. As far as I know it's the only trial worldwide testing this mix and I couldn't find anything about this mix in the trial list. Did I miss something? Kind regards, Gert In Dutch this is the press release: http://www.vumc.nl/communicatie/nieuws/index.html?../nieuws/persberichten2004/pe rs-0449%20gen-immunotherapie%20prostaattumor%20ned.html~hoofd Rgds Douwe > "Gert van der Kooij" <gert@invalid.nl> wrote... > [quoted text clipped - 12 lines] > Rgds > Douwe Thanks Douwe, I've already read that. I just couldn't find any other trial using the same combination (GVAX and MDX-010). Kind regards, Gert hi douwe - here's an abstract about phase I testing on gene therapy of hormone refractory pca. i listed other abstracts that may be of benefit..... ~ curtis Developmental Therapeutics Cancer gene therapy of hormone refractory prostate cancer. Results of a phase I trial of a retrovirally transfected IL2-IFN?-secreting allogeneic tumorvaccine Abstract No:262Author(s):H. Kübler, T. Brill, H. van Randenborgh, F. Fend, H. Pohla, D. Schendel, J. Breul, R. Paul, R. Hartung, B. Gänsbacher Abstract:Background:We propose to study whether immunization with the allogeneic HLA class I matched prostate carcinoma cell line LNCaP expressing recombinant Interleukin-2 (IL2) and Interferon-? (IFN?), will be tolerated and will be able to induce an immune response. Methods:In a phase I study patients with hormone refractory prostate cancer received four vaccinations of irradiated allogeneic LNCaP cells transduced by a retroviral vector to secrete IL2 and IFN? on days 1, 15, 29 and 92 and after that every 90 days as long as no tumor progression occurs. Patients are monitored by serial PSA measurements, bone scans, immunological parameters (ELISPOT, tetramere staining) and standard toxicity criteria (NCI CTCv99). Results: Three patients received a dose level of 7.5 million cells without grade 2, 3 or 4 toxicity, so the second dose level of 15 million cells was given to the next three patients. One patient in the second dose level developed a grade 2 reaction (pain, swelling, inflammation) after the fifth and a transient self limiting grade 3 injection site reaction (ulceration) after the eighth vaccination. There was a trend toward longer median time to disease progression in patients receiving the higher dose of cells compared to patients who were injected with the starting dose. No dose limiting or autoimmune toxicities were seen. Conclusions:Our results shows that gene therapy with a retrovirally transfected IL2-IFN?-secreting allogeneic tumorvaccine is well tolerated. The trend towards a longer time to progression must be proved. Updated clinical data from this ongoing trial will be presented. Associated Presentation(s):1. Cancer gene therapy of hormone refractory prostate cancer. Results of a phase I trial of a retrovirally transfected IL2-IFN?-secreting allogeneic tumorvaccine Event: 2005 Prostate Cancer Symposium Presenter: Hubert Kübler, MD Session: Poster Session F: Hormone Refractory Prostate Cancer; Developmental Therapeutics (No presentation available) Other Abstracts in this Sub-Category:1. MVA-MUC1-IL2 Vaccine Immunotherapy (TG4010) in patients with prostate cancer with biochemical failure Meeting: 2005 Prostate Cancer Symposium Abstract No: 249 First Author: R. Dreicer 2. Bortezomib Plus Docetaxel in Patients With Advanced Androgen-Independent Prostate Cancer: A Phase 1/2 Study Meeting: 2005 Prostate Cancer Symposium Abstract No: 250 First Author: R. Dreicer 3. A Phase 2 Study of Prostatic Acid Phosphatase-pulsed Dendritic Cells (APC8015; Provenge) in Combination with Bevacizumab in Patients with Serologic Progression of Prostate Cancer after Local Therapy Meeting: 2005 Prostate Cancer Symposium Abstract No: 251 First Author: B. Rini 4. Phase II Study of CC-4047 in Patients with Metastatic Hormone-Refractory Prostate Cancer (HRPC) Meeting: 2005 Prostate Cancer Symposium Abstract No: 252 First Author: R. J. Amato 5. Safety and tolerability of AZD2171, a highly potent VEGFR inhibitor, in patients with advanced prostate adenocarcinoma Meeting: 2005 Prostate Cancer Symposium Abstract No: 253 First Author: C. Ryan 6. A Randomized Trial of PSA-Peptide Based, Specific Active Immunotherapy in HLA-A2+ Patients with Prostate Cancer: Comparison of Two Different Vaccination Strategies Meeting: 2005 Prostate Cancer Symposium Abstract No: 254 First Author: D. Peace 7. Intraprostatic injection of mycobacterial cell wall-DNA complex (MCC): non-clinical and clinical phase-I results Meeting: 2005 Prostate Cancer Symposium Abstract No: 255 First Author: A. Morales Dr 8. Antiandrogen, Vaccine, and Combination Therapy in D0.5 Prostate Cancer Patients Meeting: 2005 Prostate Cancer Symposium Abstract No: 256 First Author: P. M. Arlen 9. Phase I study of transgenic B lymphocyte immunization (TLI) against telomerase in androgen-independent prostate cancer (PC). Meeting: 2005 Prostate Cancer Symposium Abstract No: 257 First Author: F. Millard 10. A Phase II Trial of Imatinib Mesylate in Prostate Cancer Patients (pts) with Biochemical Relapse (BCR) after Definitive Local Therapy Meeting: 2005 Prostate Cancer Symposium Abstract No: 258 First Author: A. M. Lin Other Abstracts by Author: H. K?bler1. Enhanced apoptosis in combination treatment of imatinib with anticancer drugs in human prostate cancer cell lines Meeting: 2005 Prostate Cancer Symposium Abstract No: 244 First Author: H. van Randenborgh 2. Combined administration of imatinab and ionizing radiation enhance antiproliferative effects in human prostate cancer cell lines Meeting: 2005 Prostate Cancer Symposium Abstract No: 245 First Author: H. K?bler 3. Quantitative biopsy pathology for the prediction of lymph node metastasis in clinically localized prostate carcinoma: can we recommend wide spread use of a simple algorithm? Meeting: 2005 Prostate Cancer Symposium Abstract No: 79 First Author: H. K?bler 4. In vitro cytotoxic effects of imatinib in combination with anticancer drugs in human prostate cancer cell lines Meeting: 2005 Prostate Cancer Symposium Abstract No: 246 First Author: H. K?bler Other recent articles by H K?bler: 1.[The influence of different wound drainage systems in radical retropubic prostatectomy--a prospective randomized study] Aktuelle Urol, Germany Vol 35, No 5 (9/16/2004): pp. 413-7 PMID: 15368131 [PubMed - in process] 2.Residual benign prostatic glands at the urethrovesical anastomosis after radical retropubic prostatectomy: prediction and impact on disease outcome. Eur Urol, Netherlands Vol 46, No 3 (8/13/2004): pp. 321-6 PMID: 15306101 [PubMed - in process] 3.[Significance of neoadjuvant therapy before radical prostatectomy] Urologe A, Germany Vol 43, No 6 (5/19/2004): pp. 680-8 PMID: 15148572 [PubMed - in process] 4.Morbidity of prostatic biopsy for different biopsy strategies: is there a relation to core number and sampling region? Eur Urol, Netherlands Vol 45, No 4 (3/26/2004): pp. 450-5; discussion 456 PMID: 15041108 [PubMed - in process] 5.Improved urinary continence after radical retropubic prostatectomy with preparation of a long, partially intraprostatic portion of the membraneous urethra: an analysis of 1013 consecutive cases. Prostate Cancer Prostatic Dis, England Vol 7, No 3 (6/9/2004): pp. 253-7 PMID: 15184863 [PubMed - in process] 6.Diagnosis and monitoring of urological tumors using positron emission tomography. Eur Urol, Netherlands Vol 40, No 5 (12/26/2001): pp. 481-7 PMID: 11752853 [PubMed - in process] knowledge is power - growing old is mandatory - growing wise is optional "Many more men die with prostate cancer than of it. Growing old is invariably fatal. Prostate cancer is only sometimes so." http://community.webtv.net/PALMER_ENT/doc
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