Vaccine Therapy, Chemotherapy, And GM-CSF In Treating Patients With Advanced Pancreatic Cancer

Study Overview

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

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.

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.

Pancreatic Cancer

BIOLOGICAL: allogeneic tumor cell vaccine
BIOLOGICAL: recombinant interferon alfa
BIOLOGICAL: sargramostim
DRUG: cyclophosphamide

SVMC-ONC-222P
CDR0000064749 (REGISTRY Identifier) (REGISTRY: PDQ (Physician Data Query))
NCI-V96-0886

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 1999-11-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-07-09
First Submitted that Met QC Criteria 2004-04-28	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-07-10
First Posted (ESTIMATED) 2004-04-29	Results First Posted N/A	Last Verified 2007-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Charles L. Wiseman, MD, FACP, St. Vincent Medical Center - Los Angeles

Publications

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General Publications

No publications available

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Clinical Trial Record