A Phase I Study of RAS Peptide Vaccination in Patients With Advanced Pancreatic or Colorectal Adenocarcinoma
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
Primary Purpose: Treatment
Neal J. Meropol, MD
Fox Chase Cancer Center
United States: Federal Government