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

Primary Purpose

Colorectal Cancer, Pancreatic Cancer

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
QS21
ras peptide cancer vaccine
Sponsored by
Fox Chase Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 4, 2000
    Last Updated
    July 10, 2013
    Sponsor
    Fox Chase Cancer Center
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00006387
    Brief Title
    Vaccine Therapy Plus QS21 in Treating Patients With Advanced Pancreatic or Colorectal Cancer
    Official Title
    A Phase I Study of RAS Peptide Vaccination in Patients With Advanced Pancreatic or Colorectal Adenocarcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2000 (undefined)
    Primary Completion Date
    January 2002 (Actual)
    Study Completion Date
    January 2002 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fox Chase Cancer Center
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Colorectal Cancer, Pancreatic Cancer
    Keywords
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Allocation
    N/A
    Enrollment
    7 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    QS21
    Intervention Type
    Biological
    Intervention Name(s)
    ras peptide cancer vaccine

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Neal J. Meropol, MD
    Organizational Affiliation
    Fox Chase Cancer Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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