Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 and over Other MSKCC-96021 NCI-V96-0914

Objectives

I.  Evaluate the immunogenicity of mucin core peptide plus 70-kD heat-shock 
protein (MUC-1/HSP70) in patients with resected pancreatic adenocarcinoma.

II.  Study the toxicity of MUC-1/HSP70 when used as an immunogen in these 
patients.

Entry Criteria

Disease Characteristics:

Histologically confirmed primary adenocarcinoma of the pancreas
  Confirmation by Pathology Department at Memorial Hospital

AJCC stage I/II with no evidence of disease following resection
  Resection completed within past 2 months
  Positive or negative microscopic margins

No metastatic or locally recurrent disease

Prior/Concurrent Therapy:

See Disease Characteristics
No prior chemotherapy, immunotherapy, or radiotherapy

Patient Characteristics:

Age:
  18 and over

Performance status:
  Karnofsky 80%-100%

Hematopoietic:
  WBC at least 3,000
  Lymphocytes at least 700
  Platelets at least 100,000

Hepatic:
  Not specified

Renal:
  Creatinine no greater than 2.0 mg/dL

Cardiovascular:
  No NYHA class III/IV status

Other:
  No prior splenectomy
  No serious intercurrent illness
  No active infection requiring antibiotics within 2 weeks prior to entry
  No active bleeding disorder
  No requirement for corticosteroids
  No known immunodeficiency
  No pregnant or nursing women
     Negative pregnancy test required of fertile women within 2 weeks prior to
     entry
  Effective contraception required of fertile women

Expected Enrollment

At least 3 patients/dose will be entered.

Outline

Vaccine Therapy.  Mucin Core Peptide (MUC-1) complexed with 70-kD Heat-Shock 
Protein (HSP70), MUC-1/HSP70.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Jonathan Lewis, MD, PhD, FACS, Protocol chair(Contact information may not be current)		Ph: 212-639-2940; 800-525-2225