Vaccine Therapy in Treating Patients With Colon, Pancreatic, or Lung Cancer
RATIONALE: Vaccines made from mutated ras peptides may make the body build an immune response to and kill tumor cells.
PURPOSE: Phase I trial to study the effectiveness of a vaccine containing mutated ras peptides and an immune adjuvant in treating patients who have colon, pancreatic, or lung cancer.
Recurrent Colon Cancer
Extensive Stage Small Cell Lung Cancer
Stage III Pancreatic Cancer
Stage III Rectal Cancer
Limited Stage Small Cell Lung Cancer
Recurrent Pancreatic Cancer
Recurrent Rectal Cancer
Stage III Non-small Cell Lung Cancer
Stage I Pancreatic Cancer
Stage II Non-small Cell Lung Cancer
Stage IVB Pancreatic Cancer
Stage II Pancreatic Cancer
Stage III Colon Cancer
Stage IVA Pancreatic Cancer
Drug: Detox-B adjuvant
Drug: ras peptide cancer vaccine
|Study Design:||Primary Purpose: Treatment|
|Official Title:||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|
|Study Start Date:||March 1995|
OBJECTIVES: I. Determine whether endogenous cellular or humoral immunity to a tumor-specific mutated ras protein is present in patients with colorectal, pancreatic, or lung cancer.
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 this regimen.
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 dose-limiting toxicity.
A total of 33 patients (12 in the adjuvant setting) will be accrued for this study within 12 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019006
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Study Chair:||Samir N. Khleif||National Cancer Institute (NCI)|