Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 (Anti-CTLA-4) Humanized Monoclonal Antibody (MDX-CTLA-4 NSC# 732442, Previously 720801) in Patients Previously Vaccinated With GM-CSF-Based Autologous Tumor Vaccines (CTEP Protocol Number P-5708) and Patients With Acute Myelogenous Leukemia/ Myelodysplasia, and Non-Small Cell Lung Cancer Who Have Not Received a Prior Vaccine
I. To determine the safety of MDX-CTLA-4 in patients previously and not previously
vaccinated with GM-CSF-based vaccines using lethally irradiated, autologous melanoma,
ovarian cancer, acute myelogenous leukemia/myelodysplasia or lung cancer cells.
II. To identify preliminary evidence of biologic activity and efficacy.
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody IV
over 90 minutes on day 1. Courses repeat every 2 months in the absence of disease
progression or unacceptable toxicity.
Patients are followed monthly until disease progression.
PROJECTED ACCRUAL: A total of 48 patients (12 per disease type; 36 previously treated with a
sargramostim (GM-CSF)-expressing autologous tumor cell vaccine and 12 not previously treated
with this vaccine) will be accrued for this study.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Toxicities of ipilimumab, based on the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
Up to 6 years
Dana-Farber Cancer Institute
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|