Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

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.

Entry 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

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

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

Expected Enrollment

A total of 14 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

St. Vincent Medical Center - Los Angeles

Charles Wiseman, MD, FACP, Protocol chair (Contact information may not be current)		Ph: 213-483-8464

Registry Information
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
Trial Start Date		2008-12-24
Registered in ClinicalTrials.gov		NCT00002773
Date Submitted to PDQ		1996-05-17
Information Last Verified		2007-04-20

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