Phase 2 Randomized Study of GM-CSF Gene-Modified Autologous Tumor Vaccine (CG8123) ("GVAX® Lung Cancer Vaccine")

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. To receive additional information on participating in our clinical trials, please refer to the enrollment information listed below.

Enrollment Information

In order for patient inquiries to be most efficiently processed, please call the GVAX® Lung Cancer Vaccine Clinical Trial Line: 1.866.542.8509. For international calls, please call 1.516.679.4928.

** POSTED JUNE 30, 2004 **