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
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
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.
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.
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