HER2-positive Breast Cancer Clinical Trial
Official title:
A Phase I Study of Infusion of HER-2/Neu Specific T Cells in Patients With Advanced Stage HER-2/Neu Expressing Cancers Who Have Received a HER-2/Neu Vaccine
This phase I trial studies the safety and the ability to expand laboratory-treated T cells when given together with cyclophosphamide or denileukin diftitox in treating patients with human epidermal growth factor receptor (HER)-2/neu overexpressing metastatic breast cancer, ovarian cancer, or non-small cell lung cancer previously treated with HER-2/neu vaccine. Laboratory-expanded T cells may help the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Biological therapy, such as denileukin diftitox, may stimulate the immune system in different ways and stop tumor cells from growing. Giving laboratory-treated T cells together with cyclophosphamide or denileukin diftitox may allow the immune system to kill more tumor cells
PRIMARY OBJECTIVES:
I. To assess the feasibility of expanding HER2 specific T cells ex vivo for infusion into
subjects who have advanced HER2 overexpressing cancer.
II. To assess the toxicity associated with infusing autologous HER2 specific T cells into
patients using either a single dose of cyclophosphamide or ONTAK (denileukin diftitox) prior
to T cell infusion.
SECONDARY OBJECTIVES:
I. To investigate to what extent HER2 specific T cell immunity can be boosted in individuals
treated with a single dose of cyclophosphamide of ONTAK followed by infusion of autologous
HER2 specific T cells.
II. To investigate the potential anti-tumor effects of HER2 specific T cells in patients
with HER2 overexpressing advanced-stage cancers.
III. To evaluate how long tumor antigen specific T cell immune augmentation persists in vivo
after a single dose of cyclophosphamide or ONTAK followed by infusion of autologous HER2
specific T cells.
OUTLINE: This is a dose-escalation study of ex vivo-expanded HER2-specific T cells. Patients
are assigned to 1 of 2 treatment groups.
GROUP A: Patients receive low-dose cyclophosphamide intravenously (IV) on day -1 and 3
escalating doses of autologous ex vivo-expanded HER2-specific T cells IV over 30 minutes on
days 1, 10, and 20.
GROUP B: Patients receive ONTAK (denileukin diftitox) IV over 1 hour on day -1 and 3
escalating doses of autologous ex vivo-expanded HER2-specific T cells IV over 30 minutes on
days 1, 10, and 20.
After completion of study treatment, patients are followed periodically.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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