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. Identifier: NCT00006387
Recruitment Status : Completed
First Posted : June 9, 2004
Last Update Posted : July 11, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fox Chase Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Pancreatic Cancer Biological: QS21 Biological: ras peptide cancer vaccine Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
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
Actual Primary Completion Date : January 2002
Actual Study Completion Date : January 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically confirmed advanced pancreatic or colorectal adenocarcinoma Curatively unresectable OR Recurrent following potentially curable resection OR Pancreatic adenocarcinoma that has been surgically resected within the past 12 months Must have one of the following ras gene mutations at codon 12: Glycine to cysteine Glycine to aspartic acid Glycine to valine HLA A2 required if evidence of HLA restriction for peptide presentation

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: WBC at least 3,500/mm3 Lymphocyte count at least 500/mm3 Hepatic: Bilirubin no greater than 3 mg/dL Renal: Creatinine no greater than 2 times upper limit of normal OR Creatinine clearance at least 50 mL/min Other: No active infection requiring sytemic therapy No history of severe allergy or anaphylaxis No immunodeficiency (e.g., HIV infection, lupus, or myeloma) Not pregnant Negative pregnancy test Fertile patients must use effective contraception Women must use contraception for 3 months prior to, during and for 3 months after study Men must use contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunologic therapy No other concurrent systemic immunotherapy for cancer Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent systemic chemotherapy for cancer Endocrine therapy: At least 4 weeks since prior corticosteroids No concurrent corticosteroids Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: At least 4 weeks since prior immunosuppressants (e.g., methotrexate) No concurrent immunosuppressants Concurrent nonsteroidal antiinflammatory drugs for pain palliation allowed

Information from the National Library of Medicine

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 identifier (NCT number): NCT00006387

Sponsors and Collaborators
Fox Chase Cancer Center
National Cancer Institute (NCI)
Study Chair: Neal J. Meropol, MD Fox Chase Cancer Center

Responsible Party: Fox Chase Cancer Center Identifier: NCT00006387     History of Changes
Other Study ID Numbers: FCCC-98026
NCI-T97-0051 ( Other Grant/Funding Number: NCI )
First Posted: June 9, 2004    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

Keywords provided by Fox Chase Cancer Center:
stage IV colon cancer
recurrent pancreatic cancer
stage IV rectal cancer
recurrent colon cancer
recurrent rectal cancer
adenocarcinoma of the colon
adenocarcinoma of the rectum
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Pancreatic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases
QS 21
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic