NCT00436254View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

October 31, 2001

Primary Completion Date

March 31, 2010

Study Completion Date

April 1, 2025

Conditions
HER2-positive Breast CancerStage III Ovarian Epithelial CancerStage III Ovarian Germ Cell TumorStage IIIA Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerStage IV Breast CancerStage IV Ovarian Epithelial CancerStage 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)

Trial Locations (1)

98109

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium, Seattle

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

University of Washington

OTHER

NCT00436254 - Vaccine Therapy With Sargramostim (GM-CSF) in Treating Patients With Her-2 Positive Stage III-IV Breast Cancer or Ovarian Cancer | Biotech Hunter | Biotech Hunter