Phase I Pilot Study of Vaccine Therapy With Tumor-Specific Mutated Ras Peptides in the Adjuvant Setting in Patients With Colorectal, Pancreatic, or Lung Cancer
OBJECTIVES: I. Determine whether endogenous cellular or humoral immunity to a
tumor-specific mutated ras protein is present in patients with colorectal, pancreatic, or
II. Determine whether vaccination with a synthetic peptide corresponding to the tumor's ras
mutation combined with Detox-B adjuvant can induce or boost cellular immunity to that
particular mutation in this patient population.
III. Determine the type and characteristics of any cellular immunity generated in these
patients treated with this regimen.
IV. Determine the tolerance and toxicity spectra of such peptides given with Detox-B
adjuvant in these patients.
V. Determine the immune response associated with each peptide dose in these patients.
VI. Assess any tumor response that may occur with treatment in these patients treated with
PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive tumor-specific mutated
ras peptide combined with Detox-B adjuvant subcutaneously monthly for 3 months. Treatment
continues in the absence of disease progression or unacceptable toxicity. Patients with
stable or responding disease or with a specific immunologic response may receive 3
additional monthly vaccinations.
Cohorts of 3-6 patients receive escalating doses of tumor-specific mutated ras peptide
combined with Detox-B adjuvant until the maximum tolerated dose (MTD) is determined. The
MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience
A total of 33 patients (12 in the adjuvant setting) will be accrued for this study within 12
Primary Purpose: Treatment
Samir N. Khleif
National Cancer Institute (NCI)
United States: Federal Government
|Medicine Branch||Bethesda, Maryland 20892|