Vaccine Therapy Plus QS21 in Treating Patients With Advanced Pancreatic or Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00006387|
Recruitment Status : Completed
First Posted : June 9, 2004
Last Update Posted : July 11, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Pancreatic Cancer||Biological: QS21 Biological: ras peptide cancer vaccine||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||A Phase I Study of RAS Peptide Vaccination in Patients With Advanced Pancreatic or Colorectal Adenocarcinoma|
|Study Start Date :||October 2000|
|Actual Primary Completion Date :||January 2002|
|Actual Study Completion Date :||January 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006387
|Study Chair:||Neal J. Meropol, MD||Fox Chase Cancer Center|