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
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
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
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Jonathan Lewis, MD, PhD, FACS
Investigator Role:
Study Chair
Investigator Affiliation:
Memorial Sloan-Kettering Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000065613
NCT ID:
NCT00003025
Start Date:
March 1997
Completion Date:
Related Keywords:
- Pancreatic Cancer
- stage I pancreatic cancer
- stage II pancreatic cancer
- adenocarcinoma of the pancreas
- Adenocarcinoma
- Pancreatic Neoplasms
Name | Location |
|---|---|
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
