Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2 Positive Stage III-IV Breast Cancer or Ovarian Cancer

Summary

RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving vaccine therapy together with sargramostim may be an effective treatment for breast cancer and ovarian cancer. PURPOSE: This phase I trial is studying the side effects and identifying the best dose of vaccine therapy when given together with sargramostim in treating patients with stage III-IV breast cancer or ovarian cancer.

Conditions

• HER2-positive Breast Cancer
• Stage III Ovarian Epithelial Cancer
• Stage III Ovarian Germ Cell Tumor
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer
• Stage IV Breast Cancer
• Stage IV Ovarian Epithelial Cancer
• Stage IV Ovarian Germ Cell Tumor

Interventions

BIOLOGICAL

pNGVL3-hICD vaccine

Plasmid-based DNA vaccine, given intradermally

BIOLOGICAL

sargramostim

Given intradermally

OTHER

flow cytometry

Correlative studies

OTHER

immunologic technique

Correlative studies

OTHER

immunoenzyme technique

Undergo ELIspot (correlative studies)

GENETIC

protein expression analysis

Undergo ELISA (correlative studies)

PROCEDURE

biopsy

Undergo punch biopsy (correlative studies)

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Washington

  lead OTHER

Principal Investigators

• Mary L. Disis · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-10-31

Primary Completion

2010-03-31

Completion

2025-04-01

Countries

• United States

Study Locations