Patient Abstract available in the near future.

Condition	Treatment or Intervention	Phase
stage I pancreatic cancer stage II pancreatic cancer stage IVA pancreatic cancer stage III pancreatic cancer	Drug: MUC-1 antigen  Drug: SB AS-2	Phase I

Further Study Details: 

OBJECTIVES: I. Determine the safety and toxicity of vaccination with MUC-1 antigen and immunologic adjuvant SB AS-2 in patients with resected or locally advanced unresectable pancreatic cancer. II. Determine the maximum tolerated dose and/or recommended phase II dose of MUC-1 antigen in this patient population. III. Determine the qualitative and quantitative tumor response to this treatment in these patients. IV. Determine the disease-free survival in resected patients, progression-free survival in locally advanced unresectable patients, and overall survival in all patients receiving this treatment.

PROTOCOL OUTLINE: This is a dose escalation study of MUC-1 antigen. Patients receive vaccination with MUC-1 antigen and immunologic adjuvant SB AS-2 intramuscularly on day 1. Treatment repeats every 3 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 1 year after the last vaccination, patients without recurrent disease may receive booster vaccines annually. Cohorts of 4 to 8 patients receive escalating doses of MUC-1 antigen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4 or 2 of 8 patients experience dose-limiting toxicity. Patients are followed at 2 weeks.

PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed resected or locally advanced unresectable pancreatic cancer
• No metastases

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy
• Endocrine therapy: No concurrent glucocorticosteroids
• Radiotherapy: No prior radiotherapy
• Surgery: At least 3 weeks since prior resection of pancreatic cancer
• Other: No concurrent non-steroidal anti-inflammatory drugs (NSAIDs)

--Patient Characteristics--

• Age: Over 18
• Performance status: ECOG 0-2
• Life expectancy: At least 4 months
• Hematopoietic: WBC greater than 3,500/mm3; Platelet count greater than 100,000/mm3
• Hepatic: Bilirubin no greater than 2.0 mg/dL
• Renal: Creatinine no greater than 1.5 mg/dL
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective double barrier contraception 1 week before, during, and for at least 2 weeks after study

Pennsylvania
      University of Pittsburgh Cancer Institute, Pittsburgh,  Pennsylvania,  15213,  United States

Study chairs or principal investigators

Ramesh Ramanathan,  Study Chair,  University of Pittsburgh Cancer Institute   

Study ID Numbers:  CDR0000068375; PCI-97-046; NCI-G00-1888; PCI-IRB-970871
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  January 6, 2001
ClinicalTrials.gov Identifier:  NCT00008099
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08