Guest It's Fay A. Posted February 24, 2004 Share Posted February 24, 2004 here is info on GVAX Trial: Trial Name: A Phase 2 Randomized Study of GM-CSF Gene-Modified Autologous Tumor Vaccine (CG8123) ("GVAX® Lung Cancer Vaccine") with and without Low-Dose Cyclophosphamide in Advanced Stage Non Small-Cell Lung Cancer Trial #: D-0031 Objectives • To evaluate the safety and clinical anti-tumor response to vaccination with GVAX® lung cancer vaccine administered with and without immunomodulatory doses of cyclophosphamide, a chemotherapeutic agent. • To evaluate the improvement in quality of life focused on cancer-associated symptoms • To evaluate the feasibility and consistency of vaccine manufacturing using a new closed-system manufacturing process • To evaluate progression-free and overall survival of patients treated with GVAX® lung cancer vaccine with and without cyclophosphamide Eligibility • Non small-cell lung cancer, stage IIIB/IV • No prior treatment with gene therapy • Accessible and adequate tumor source for vaccine production with measurable disease to evaluate following tumor procurement Treatment Tumors from planned surgical resection will be processed and made into the treatment vaccine. Prior to treatment, patients will be randomized at a ratio of 1:1 into one of two treatment groups, Cohort A and Cohort B. Patients in Cohort A will be treated with GVAX® lung cancer vaccine only and patients in Cohort B will be treated with GVAX® lung cancer vaccine plus a single dose of cyclophosphamide administered one day prior to the first, third, and fifth vaccine treatment. Patients will receive intradermal (beneath the skin) vaccine injections every two weeks for up to eight weeks, for a total of up to five vaccine treatments. The duration of this study, including follow up, is approximately two years. In order to assist you and your physician with determining whether this trial is appropriate for you, select major eligibility criteria are listed above. If you live near a listed clinical trial site and believe you may be a candidate for this clinical trial, please contact the clinical trial site directly for additional information, including detailed eligibility criteria. The contact information is listed below. Participating Clinical Trial Site Mary Crowley Medical Research Center John Nemunaitis, M.D. 3535 Worth St. Dallas, TX 75246 Contact: Ned Adams, RN 214.370.1815 Tyler Cancer Center Donald A. Richards, M.D. 910 E. Manning Blvd. Tyler, TX 75702 Contact: Linda Dunklin, RN 903.579.9800 Cancer Centers of Florida Barry Berman, M.D. 1111 Blackwood Avenue Ocoee, FL 34761 Contact: Patricia De Leon, RN 407.292.3042 Providence Portland Medical Center Helen Ross, M.D. Chiles Research Institute 4805 N. E. Glisan Room 5F40 Portland, Oregon Contact: Teri Doran, RN 503.215.6412 Albany Regional Cancer Center James Arseneau, M.D. 317 S. Manning , #330 Albany, NY 12208 Contact: Michele Butler, RN 518.489.2607 University of California Mount Zion Comprehensive Cancer Center David Jablons, M.D. 1600 Divisadero Street, Fourth Floor San Francisco, CA 94115 Contact: Bob Kuhn, Study Coordinator 415.885.7333 University of Wisconsin Comprehensive Cancer Center Joan Schiller, M.D. 600 Highland Avenue Room K4/636 Madison, WI 53792 Contact: Cancer Connect 800.622.8922 Cancer Care Northwest Stephen Anthony, M.D. 605 W. Holland, Ste 100 Spokane, WA 99218 Contact: Jeanne Fuller, RN, OCN 509.464.5137 University of Colorado Health Sciences Center Karen Kelly, M.D. Anschutz Cancer Pavilion 1665 N. Ursula Street Aurora, CO 80010-0510 Contact: Lyn Magree, Study Coordinator 720.848.0676 Hackensack University Medical Center Harry Harper, M.D. 20 Prospect Avenue Suite 400 Hackensack, NJ 07601 Contact: Diane DenBleyker, RN 201.336.8455 University of Pennsylvania 833 W. Gates Building, H.U.P. 3400 Spruce Street Philadelphia, PA 19104 Contact: Adri Recio, RN Phone: 215-573-6760 Vanderbilt University Vanderbilt-Ingram Cancer Center David Carbone, M.D. Clinical Trials Office 491 Preston Building Nashville, TN 37232 Contact: Cancer Information Program Phone: 1-800-811-8480 Additional clinical trial sites are expected to be added over the coming months as the GVAX® lung cancer vaccine study is expanded. Quote Link to comment Share on other sites More sharing options...
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