Vaccine Therapy in Treating Patients With Resected or Locally Advanced Unresectable Pancreatic Cancer
NCT ID: NCT00008099
Last Updated: 2016-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
25 participants
INTERVENTIONAL
1998-05-31
2004-02-29
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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MUC1 antigen/SB AS-2
Eligibility Criteria
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Inclusion Criteria
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
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)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Herbert J. Zeh, III MD, FACS
Associate Professor
Principal Investigators
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Ramesh K. Ramanathan, MD
Role: STUDY_CHAIR
University of Pittsburgh
Locations
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University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Countries
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Other Identifiers
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CDR0000068375
Identifier Type: REGISTRY
Identifier Source: secondary_id
PCI-IRB-970871
Identifier Type: -
Identifier Source: secondary_id
NCI-G00-1888
Identifier Type: -
Identifier Source: secondary_id
PCI-97-046
Identifier Type: -
Identifier Source: org_study_id
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