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

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	Other	SVMC-ONC-222P NCI-V96-0886, NCT00002773

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