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	Treatment or Intervention	Phase
stage I pancreatic cancer stage II pancreatic cancer adenocarcinoma of the pancreas	Drug: gp96 heat shock protein-peptide complex	Phase I

Further Study Details: 

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.

PROTOCOL 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 above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven, resected, stage I or II pancreatic adenocarcinoma

--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

--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

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Jonathan Lewis,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000065613; MSKCC-97034; NCI-G97-1271; ANTIGENICS-C-100-01
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003025
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08