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


Phase 1
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer, Pancreatic Cancer

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Trial Information

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
months.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Neal J. Meropol, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fox Chase Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000068265

NCT ID:

NCT00006387

Start Date:

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Pancreatic Cancer
  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Colorectal Neoplasms
  • Pancreatic Neoplasms

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