Vaccine Therapy Plus QS21 in Treating Patients With Advanced Pancreatic or Colorectal Cancer
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. QS21 may improve the ability of the immune system to respond to disease. Combining vaccine therapy with QS21 may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus QS21 in treating patients who have advanced pancreatic or colorectal cancer.
Biological: ras peptide cancer vaccine
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||A Phase I Study of RAS Peptide Vaccination in Patients With Advanced Pancreatic or Colorectal Adenocarcinoma|
|Study Start Date:||October 2000|
|Study Completion Date:||January 2002|
|Primary Completion Date:||January 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the toxicity of ras peptide cancer vaccine plus immunological adjuvant QS21 in patients with advanced pancreatic or colorectal adenocarcinoma. II. Determine the immunologic effects of this treatment regimen in these patients. III. Determine the antitumor effect of this treatment regimen in these patients.
OUTLINE: This is a dose escalation study of ras peptide cancer vaccine. Patients receive ras peptide cancer vaccine mixed with immunological adjuvant QS21 subcutaneously monthly for 4 doses, every 2 months for 4 doses, every 4 months for 3 doses, every 6 months for 2 doses, and then annually thereafter in the absence of unacceptable toxicity. Cohorts of 3 to 6 patients receive escalating doses of ras peptide cancer vaccine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 4 patients experience dose limiting toxicity.
PROJECTED ACCRUAL: Approximately 15-20 patients will be accrued for this study within 30 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006387
|Study Chair:||Neal J. Meropol, MD||Fox Chase Cancer Center|