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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Toxicities of ipilimumab, based on the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
This phase I trial is studying the side effects of monoclonal antibody therapy in treating patients with ovarian epithelial cancer, melanoma, acute myeloid leukemia, myelodysplastic syndrome, or non-small cell lung cancer. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells
Detailed Description
PRIMARY OBJECTIVES: 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. OUTLINE: 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients previously vaccinated with GM-CSF-based vaccines using lethally irradiated, autologous melanoma, ovarian cancer, acute myelogenous leukemia/myelodysplasia, or non-small cell lung cancer cells; patients with acute myelogenous leukemia/myelodysplasia or non-small cell lung cancer who have not been vaccinated with an autologous, GM-CSF based vaccine
- •\>= 4 weeks since treatment (chemo-, radiation, hormone, immuno-, etc., therapy)
- •Patients must have recovered from any acute toxicity associated with prior therapy
- •Measurable epithelial ovarian cancer, melanoma, AML/MDS, or non-small cell lung cancer
- •No standard curative treatment options
- •Not require immediate palliative therapy
- •Patients with epithelial ovarian cancer must have persistent or recurrent disease following primary surgery and primary chemotherapy
- •Patients with melanoma must be stage IV disease
- •Patients with AML/MDS, but without MDS, must be: a) in second relapse or b) first relapse with no option for bone marrow transplant or c) not a candidate for immunosuppressive chemotherapy due to age or comorbid disease
- •Patients with non-small cell lung cancer must be not curable by standard surgery, chemotherapy, and/or radiation
Exclusion Criteria
- •Active infection
- •Autoimmune disease requiring immunosuppressive treatment
- •Any underlying medical condition which, in the principal investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of adverse events
- •Any concurrent medical condition requiring the use of systemic steroids (use of inhaled or topical steroids is acceptable)
- •CNS metastases, unless previously treated and stable for at least three months
- •Patients who have received prior treatment with MDX-CTLA-4
Outcomes
Primary Outcomes
Toxicities of ipilimumab, based on the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
Time Frame: Up to 6 years
Secondary Outcomes
- Proportion of patients who mount a brisk immune response, graded as absent, non-brisk, and brisk as described by Mihm(Up to 2 months post-treatment)
- Overall clinical response rate (complete response [CR] plus partial response [PR]) based on the Response Evaluation Criteria in Solid Tumors (RECIST)(Up to 6 years)