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Vaccine Therapy in Treating Patients With Stage I or Stage II Pancreatic Cancer

This study has been completed.
Information provided by:
Memorial Sloan Kettering Cancer Center Identifier:
First received: November 1, 1999
Last updated: July 1, 2013
Last verified: July 2013

RATIONALE: Vaccines made from a person's cancer cells may make the body build an immune response to and kill tumor cells. Combining vaccine therapy with surgery may be an effective treatment for pancreatic cancer.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients with stage I or stage II pancreatic cancer that has been surgically removed.

Condition Intervention Phase
Pancreatic Cancer
Biological: vitespen
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase I Pilot Trial of Immunotherapy With Autologous Tumor-Derived gp96 Heat Shock Protein - Peptide Complex (HSPPC-96) in Patients With Resected Pancreatic Adenocarcinoma

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Estimated Enrollment: 16
Study Start Date: March 1997
Study Completion Date: July 2002
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES: I. Study the safety of autologous tumor derived gp96 heat shock protein peptide complex (HSPPC-96) in patients with resected pancreatic adenocarcinoma. II. Examine the immune response to HSPPC-96 in this group of patients.

OUTLINE: This is a dose escalation study. Six weeks after surgery patients are given autologous tumor derived gp96 heat shock protein peptide complex (HSPPC-96) subcutaneously once a week for 4 weeks. Five patients are initially enrolled at each of two dose levels. An additional three patients may be enrolled at each dose level to determine the optimal dose of HSPPC-96. Patients are followed at weeks 1, 4, and 12 after treatment.

PROJECTED ACCRUAL: A maximum of 16 patients will be accrued for this study.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically proven, resected, stage I or II pancreatic adenocarcinoma

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 3000/mm3 Lymphocyte count at least 700/mm3 Platelet count at least 100,000/mm3 Hepatic: Not specified Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No clinically significant heart disease Other: No other serious illness No active infections requiring antibiotics within past 2 weeks Not pregnant or nursing Fertile patients must use effective birth control No known immunodeficiency No active bleeding

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent corticosteroids Radiotherapy: No prior radiation therapy Surgery: Must undergo Whipple procedure or distal pancreatectomy at Memorial Hospital Must not have undergone splenectomy Other: No investigational treatment within 2 months of surgery No immunosuppressive therapies

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Please refer to this study by its identifier: NCT00003025

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Study Chair: Jonathan Lewis, MD, PhD, FACS Memorial Sloan Kettering Cancer Center
  More Information

Maki RG, Lewis JJ, Janetzki S, et al.: Phase I study of HSPPC-96 (oncophage®) vaccine in patients with completely resected pancreatic adenocarcinoma. [Abstract] European Journal of Cancer Supplements 1 (5): A-48, S19, 2003. Identifier: NCT00003025     History of Changes
Other Study ID Numbers: 97-034
CDR0000065613 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: November 1, 1999
Last Updated: July 1, 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
stage I pancreatic cancer
stage II pancreatic cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases processed this record on April 25, 2017