NCT00228358View on ClinicalTrials.gov

Cyclophosphamide or Denileukin Diftitox Followed By Expanding a Patient's Own T Cells in the Laboratory in Treating Patients With HER-2/Neu Overexpressing Metastatic Breast Cancer, Ovarian Cancer, or Non-Small Cell Lung Cancer Previously Treated With HER-2/Neu Vaccine

PHASE1CompletedINTERVENTIONAL
Enrollment

8

Participants

Timeline

Start Date

June 30, 2003

Primary Completion Date

May 31, 2011

Conditions
HER2-positive Breast CancerRecurrent Breast CancerRecurrent Non-small Cell Lung CancerRecurrent Ovarian Epithelial CancerRecurrent Ovarian Germ Cell TumorStage IV Breast CancerStage IV Non-small Cell Lung CancerStage IV Ovarian Epithelial CancerStage IV Ovarian Germ Cell Tumor
Interventions
DRUG

ex vivo-expanded HER2-specific T cells

Laboratory-expanded T cells, given IV

DRUG

cyclophosphamide

Given IV

BIOLOGICAL

denileukin diftitox

Given IV

OTHER

flow cytometry

Intracellular cytokine staining (correlative study)

OTHER

immunoenzyme technique

ELIspot assay (correlative study)

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

NCT00228358 - Cyclophosphamide or Denileukin Diftitox Followed By Expanding a Patient's Own T Cells in the Laboratory in Treating Patients With HER-2/Neu Overexpressing Metastatic Breast Cancer, Ovarian Cancer, or Non-Small Cell Lung Cancer Previously Treated With HER-2/Neu Vaccine | Biotech Hunter | Biotech Hunter