Vaccine Therapy in Treating Patients With Resected or Locally Advanced Unresectable Pancreatic Cancer

Phase 1

Completed

• Conditions: Pancreatic Cancer

• Registration Number: NCT00008099
• Lead Sponsor: University of Pittsburgh

Brief Summary

RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of vaccine therapy in treating patients with resected or locally advanced unresectable pancreatic cancer.

Detailed Description

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.

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.

Study Timeline

• Study Start: 1998-05
• Study First Submitted: 2001-01-06
• Primary Completion: 2001-03
• Study Completion: 2004-02
• Study First Submitted QC: 2004-05-03
• Study First Posted: 2004-05-04
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-19
• Last Update Posted: 2016-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Disease Recurrence	1-2 years

Secondary Outcome Measures

Name	Time	Method
Overall Survival	2-5 years

Trial Locations

Locations (1)

University of Pittsburgh Cancer Institute; 🇺🇸 Pittsburgh, Pennsylvania, United States