Know Cancer

or
forgot password

Phase I Dose Escalation Trial of a 100 aa Synthetic Mucin Peptide Admixed With SB-AS2 as Adjuvant in Locally Advanced and Resected Pancreatic Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

Phase I Dose Escalation Trial of a 100 aa Synthetic Mucin Peptide Admixed With SB-AS2 as Adjuvant in Locally Advanced and Resected Pancreatic Cancer


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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed resected or locally advanced
unresectable pancreatic cancer No metastases

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)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Ramesh K. Ramanathan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Pittsburgh

Authority:

United States: Federal Government

Study ID:

CDR0000068375

NCT ID:

NCT00008099

Start Date:

May 1998

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213