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

Alternate Title

HER-2/neu Vaccine in Treating Patients With Recurrent Metastatic Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI NCI-97-C-0118 NCI-T97-0009, T97-0009

Objectives

I. Evaluate the toxic effects and immunologic reactivity of HER2-Neu peptide
vaccine preparations in HLA-A2.1 positive patients with metastatic cancer.

Entry Criteria

Disease Characteristics:

Histologically proven recurrent metastatic cancer, including:
 Breast      Colorectal    
 Ovary       Prostate

HLA-A2.1 positive

Prior/Concurrent Therapy:

Biologic therapy:
 At least 4 weeks since prior biologic therapy
 No other concurrent biologic therapy

Chemotherapy:
 At least 4 weeks since prior chemotherapy
 No concurrent chemotherapy

Endocrine therapy:
 At least 4 weeks since prior endocrine therapy
 No concurrent steroid therapy

Radiotherapy:
 At least 4 weeks since prior radiotherapy
 No concurrent radiotherapy

Surgery:
 Prior or concurrent surgery is allowed

Patient Characteristics:

Age:
 18 and over

Performance Status:
 ECOG 0 or 1

Life Expectancy:
 Greater than 3 months

Hematopoietic:
 WBC at least 3000/mm3
 Platelet count at least 90,000/mm3
  
Hepatic:
 Bilirubin no greater than 1.6 mg/dL
 AST or ALT less than 2.0 times normal

Renal:
 Creatinine no greater than 2.0 mg/dL
 Creatinine clearance at least 60 mL/min

Cardiovascular:
 No cardiovascular illness

Pulmonary:
 No respiratory system illness

Other:
 Not pregnant 
 No hepatitis B
 No active systemic infections or coagulation disorders
 Not HIV positive
 No prior allergic reaction to incomplete Freund's adjuvant 

Expected Enrollment

A total of 3-9 patients will be enrolled in each cohort for each histologic 
type of cancer (a maximum of 54 patients).

Outline

Recurrent metastatic cancer patients are analyzed for overexpression of the 
HER2-Neu protein. Patients exhibiting overexpression are immunized with the
HER2-Neu peptide, KIFGSLAFL.  Patients receive peptide emulsified in Montanide 
ISA-51 subcutaneously every three weeks for 4 courses.  In selected cohorts  
interleukin-2 (IL-2), sargramostim (GM-CSF) or interleukin-12 is administered 
with the vaccine.  In cohorts receiving IL-2, the first dose is administered 
within 24 hours after peptide injection. 

If grade III-IV toxic effects are attained with the peptide preparation given 
alone in an individual patient, at least six patients must be treated with 
that preparation prior to addition of cytokines. If a second patient develops
such toxic effects, that schedule of peptide administration is discontinued. 
Any patient who develops grade III-IV toxic effects due to
vaccine injections is removed from the protocol.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Steven Rosenberg, MD, PhD, Protocol chair		Ph: 866-820-4505 Email: sar@nih.gov