A Phase I Study of a HER-2/Neu Peptide Based Vaccine With GM-CSF as an Adjuvant in Patients With Advanced Stage HER-2/Neu Expressing Cancers


Phase 1
N/A
N/A
Not Enrolling
Both
Breast Cancer, Lung Cancer, Ovarian Cancer

Thank you

Trial Information

A Phase I Study of a HER-2/Neu Peptide Based Vaccine With GM-CSF as an Adjuvant in Patients With Advanced Stage HER-2/Neu Expressing Cancers


OBJECTIVES: I. Determine the safety of serial intradermal vaccinations of HER-2/neu derived
peptides with sargramostim (GM-CSF) as an adjuvant in patients with stage III or IV
HER-2/neu expressing breast, ovarian, or nonsmall cell lung cancer. II. Determine whether
immunity can be elicited with peptides derived from the intracellular domain of the
HER-2/neu protein. III. Determine whether immunity can be elicited with peptides derived
from the extracellular domain of the HER-2/neu protein. IV. Determine whether cytotoxic T
cells specific for the HER-2/neu protein can be elicited in patients with HLA-A2 by
immunization with peptides derived from the HER-2/neu protein.

OUTLINE: Patients receive one of three HER-2/neu peptide vaccine formulations that also
contain sargramostim (GM-CSF) as the vaccine adjuvant. Each vaccine is studied in 20
patients. A maximum of 3 patients receive a vaccine each month for 6 months to monitor the
potential toxicity associated with sequential immunizations. Patients receive a follow-up
evaluation 1 month after the last vaccination. Those patients who have an immune response
related to the vaccine will continue to have immunologic evaluations performed every 2
months while immune responses can still be detected.

PROJECTED ACCRUAL: 60 patients will be accrued.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven stage III or IV breast, ovarian, or
nonsmall cell lung cancer (NSCLC): Adenocarcinoma No progressive disease May have
comlpeted at least 1 standard chemotherapy regimen Confirmed HER-2/neu protein
overexpression in tumor (either primary tumor or metastasis)

PATIENT CHARACTERISTICS: Age: Pre or postmenopausal Performance status: Not specified Life
expectancy: At least 12 months Hematopoietic: WBC greater than 3,500/mm3 Platelet count
greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less
than 1.5 mg/dL Creatinine clearance greater than 60 mL/min Other: No anergy (positive
delayed type hypersensitivity response required to two or more common recall antigens)
Female patients must be nonfertile Male patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics At least 1 month since cytotoxic chemotherapy Endocrine therapy: At least
1 month since corticosteroid therapy Concurrent hormone therapy allowed Radiotherapy:
Concurrent radiation therapy for local control of disease allowed (except as initial
therapy for NSCLC) Surgery: Not specified

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Mary (Nora) L. Disis, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Washington

Authority:

United States: Federal Government

Study ID:

CDR0000065564

NCT ID:

NCT00003002

Start Date:

April 1996

Completion Date:

January 2004

Related Keywords:

  • Breast Cancer
  • Lung Cancer
  • Ovarian Cancer
  • stage III breast cancer
  • stage IV breast cancer
  • stage III non-small cell lung cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • stage IV non-small cell lung cancer
  • adenocarcinoma of the lung
  • Breast Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Ovarian Neoplasms

Name

Location
University of Washington School of Medicine Seattle, Washington  98195