NCT00436254

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

A Phase I Study of a DNA Plasmid Based Vaccine Encoding the HER-2/Neu Intracellular Domain in Subjects With HER-2/Neu (HER2) Overexpressing Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the safety of intradermal administration of 3 doses of a plasmid-based DNA vaccine encoding the ICD of HER2 administered with a fixed dose of GM-CSF. II. To determine whether a plasmid DNA vaccine encoding the ICD of HER2 can elicit HER2 specific immune responses. SECONDARY OBJECTIVES: I. To determine if the dose of the plasmid-based DNA vaccine effects immunologic responses. II. To determine the persistence of DNA at the site of vaccination. OUTLINE: This is a dose-escalation study of a plasmid-based DNA (pNGVL3-hICD) vaccine. Patients receive pNGVL3-hICD vaccine admixed with GM-CSF intradermally once a month for 3 months in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically for up to 15 years with primary physicians.

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

Type	Name	Description
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)

Timeline

• Start date: 2001-10-01
• Primary completion: 2010-03-01
• Completion: 2025-04-01
• First posted: 2007-02-19
• Last updated: 2025-04-06

Locations

1 site across 1 country: United States