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contact info for GVAX Trial

Guest It's Fay A.

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Guest It's Fay A.

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


• 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


• 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


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


Tyler Cancer Center

Donald A. Richards, M.D.

910 E. Manning Blvd.

Tyler, TX 75702

Contact: Linda Dunklin, RN


Cancer Centers of Florida

Barry Berman, M.D.

1111 Blackwood Avenue

Ocoee, FL 34761

Contact: Patricia De Leon, RN


Providence Portland Medical Center

Helen Ross, M.D.

Chiles Research Institute

4805 N. E. Glisan

Room 5F40

Portland, Oregon

Contact: Teri Doran, RN


Albany Regional Cancer Center

James Arseneau, M.D.

317 S. Manning , #330

Albany, NY 12208

Contact: Michele Butler, RN


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


University of Wisconsin Comprehensive Cancer Center

Joan Schiller, M.D.

600 Highland Avenue

Room K4/636

Madison, WI 53792

Contact: Cancer Connect


Cancer Care Northwest

Stephen Anthony, M.D.

605 W. Holland, Ste 100

Spokane, WA 99218

Contact: Jeanne Fuller, RN, OCN


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


Hackensack University Medical Center

Harry Harper, M.D.

20 Prospect Avenue

Suite 400

Hackensack, NJ 07601

Contact: Diane DenBleyker, RN


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.

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