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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003025
First Posted: August 12, 2004
Last Update Posted: July 3, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Memorial Sloan Kettering Cancer Center
  Purpose

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.

  Eligibility

Information from the National Library of Medicine

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

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003025


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

Publications:
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.

ClinicalTrials.gov Identifier: NCT00003025     History of Changes
Other Study ID Numbers: 97-034
CDR0000065613 ( Registry Identifier: PDQ (Physician Data Query) )
ANTIGENICS-C-100-01
NCI-G97-1271
First Submitted: November 1, 1999
First Posted: August 12, 2004
Last Update Posted: July 3, 2013
Last Verified: July 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
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases