Clinical Trials Directory

Trials / Completed

CompletedNCT00006387

Vaccine Therapy Plus QS21 in Treating Patients With Advanced Pancreatic or Colorectal Cancer

A Phase I Study of RAS Peptide Vaccination in Patients With Advanced Pancreatic or Colorectal Adenocarcinoma

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
7 (actual)
Sponsor
Fox Chase Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALQS21
BIOLOGICALras peptide cancer vaccine

Timeline

Start date
2000-10-01
Primary completion
2002-01-01
Completion
2002-01-01
First posted
2004-06-09
Last updated
2013-07-11

Source: ClinicalTrials.gov record NCT00006387. Inclusion in this directory is not an endorsement.