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Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
allogeneic tumor cell vaccine
recombinant interferon alfa
sargramostim
cyclophosphamide
Sponsored by
St. Vincent Medical Center - Los Angeles
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, 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 adenocarcinoma of the pancreas that is locoregionally active or metastatic and not amenable to cure or long-term control by surgery, radiotherapy, or chemotherapy No brain metastases refractory to irradiation or surgery PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 OR Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No prior or concurrent significant cardiovascular disease Pulmonary: No prior or concurrent significant pulmonary disease Other: No AIDS HIV negative No prior or concurrent autoimmune disease No other concurrent major medical illness Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: No concurrent chronic steroid therapy Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: At least 4 weeks since other prior therapy

Sites / Locations

  • St. Vincent Medical Center - Los Angeles

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
July 9, 2013
Sponsor
St. Vincent Medical Center - Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT00002773
Brief Title
Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer
Official Title
A CLINICAL TRIAL FOR PANCREAS CANCER USING ACTIVE INTRALYMPHATIC IMMUNOTHERAPY WITH INTERFERON-TREATED PANCREAS CANCER TISSUE CULTURE CELLS, GMCSF, AND LOW-DOSE CYCLOPHOSPHAMIDE
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
May 1996 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
St. Vincent Medical Center - Los Angeles

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Vaccines made from donated tumor cells treated with interferon alfa may make the body build an immune response to and kill pancreatic tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors may help a person's immune system recover from the side effects of chemotherapy. Combining these treatments may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy using donated tumor cells treated with interferon alfa and radiation therapy and cyclophosphamide plus GM-CSF in treating patients with advanced pancreatic cancer.
Detailed Description
OBJECTIVES: I. Determine the feasibility, toxicity, and antitumor effects of active specific intralymphatic immunotherapy with allogeneic pancreatic cancer cells treated with interferon alfa plus low-dose adjuvant systemic sargramostim (GM-CSF) and cyclophosphamide in patients with incurable pancreatic adenocarcinoma. II. Assess the immunologic and biologic correlates of this treatment regimen in these patients. OUTLINE: Cultured allogeneic pancreatic cancer cells are incubated with interferon alfa for 72-96 hours. Autologous cell lines, if established, may be used as an alternative. The cells are irradiated immediately prior to use. Patients receive cyclophosphamide IV on day -3 and sargramostim (GM-CSF) subcutaneously on days 0-8. On day 0, patients receive viable tumor cells via dorsal pedal lymphatic cannulation. Treatment repeats every 2-4 weeks for a minimum of 8 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-4 months. PROJECTED ACCRUAL: A total of 14 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
allogeneic tumor cell vaccine
Intervention Type
Biological
Intervention Name(s)
recombinant interferon alfa
Intervention Type
Biological
Intervention Name(s)
sargramostim
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the pancreas that is locoregionally active or metastatic and not amenable to cure or long-term control by surgery, radiotherapy, or chemotherapy No brain metastases refractory to irradiation or surgery PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-3 OR Karnofsky 60-100% Life expectancy: At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No prior or concurrent significant cardiovascular disease Pulmonary: No prior or concurrent significant pulmonary disease Other: No AIDS HIV negative No prior or concurrent autoimmune disease No other concurrent major medical illness Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy Endocrine therapy: No concurrent chronic steroid therapy Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: See Disease Characteristics Other: At least 4 weeks since other prior therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles L. Wiseman, MD, FACP
Organizational Affiliation
St. Vincent Medical Center - Los Angeles
Official's Role
Study Chair
Facility Information:
Facility Name
St. Vincent Medical Center - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer

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