Vaccine Therapy in Treating Patients With Resected or Locally Advanced Unresectable Pancreatic Cancer - Full Text View

Sponsor:	UPMC Cancer Centers
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00008099

Purpose

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.

Condition	Intervention	Phase
Pancreatic Cancer	Biological: MUC-1 antigen/SB AS-2	Phase I

Study Type:	Interventional
Study Design:	Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

May 1998

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00008099

Locations

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

Sponsors and Collaborators

UPMC Cancer Centers

National Cancer Institute (NCI)

Investigators

Study Chair:

Ramesh K. Ramanathan, MD

UPMC Cancer Centers

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068375, PCI-97-046, PCI-IRB-970871, NCI-G00-1888
Study First Received:	January 6, 2001
Last Updated:	July 29, 2009
ClinicalTrials.gov Identifier:	NCT00008099 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms

Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on November 05, 2009