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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

Thank you

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 CenterNew York, New York  10021