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A Pilot Trial Assessing the Safety and Immunogenicity of the GI-4000 Vaccine as Consolidation Therapy after Curative Treatment for Stage I-III Non-Small Cell Lung Cancers with K-ras Mutations

[Protocol 07-149]

Full Title :
A PILOT TRIAL OF THE IMMUNOGENICITY, AND SAFETY OF GI-4000, AN INACTIVATED RECOMBINANT SACCHAROMYCES CEREVISIAE EXPRESSING MUTANT RAS PROTEIN, AS CONSOLIDATION THERAPY FOLLOWING CURATIVE TREATMENT FOR STAGE I-III NON-SMALL CELL LUNG CANCER (NSCLC) WITH TUMOR SEQUENCE CONFIRMATION OF K-RAS MUTATION
Purpose :

Patients who have non-small cell lung cancer which contains an altered (mutant) form of the Ras protein may be less likely to benefit from chemotherapy, and have an increased chance that their cancer will return. The purpose of this study is to test whether a new vaccine, called GI-4000, causes the immune system to recognize and destroy cells which contain a mutant form of the Ras protein.

GI-4000 is baker's yeast (the yeast commonly used to make bread or beer) which has been genetically changed so that it produces mutant Ras. The modified GI-4000 yeast cells are injected into the skin as a vaccine. After treatment with GI-4000 vaccine, patients in this study will have their blood tested to see whether the immune system reacts to the mutant Ras. If GI-4000 is found to be safe and causes an immune response, then a larger study will be conducted to determine whether GI-4000 improves the rate of cure for patients with non-small cell lung cancer with mutant Ras.

Eligibility :

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have a confirmed diagnosis of stage I-III non-small cell lung cancer that has been treated with standard therapy and displays no evidence of disease at the first surveillance follow-up visit (1 to 4 months after completing treatment).
  • Patients must have cancer which contains a mutant K-ras gene. This test is available at MSKCC, and is perfomed on cancer tissue which has already been removed at the time of biopsy or during surgery.
  • Patients must not have a history of an allergy to baker's yeast.
  • Patients must not be confined to a bed or chair for more than half of their normal waking hours.
  • Patients must be age 18 or older.

For more information and to inquire about eligibility for this study, please contact Dr. Christopher Azzoli at 212-639-2131 or Dr. Bernard J. Park at 212-639-8874.

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