Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer
- Conditions
- Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Atypical Chronic Myeloid Leukemia, BCR-ABL1 NegativeRecurrent Adult Acute Myeloid LeukemiaRecurrent MelanomaStage IV MelanomaStage IV Non-small Cell Lung CancerAdult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Inv(16)(p13;q22)
- Interventions
- Biological: ipilimumab
- Registration Number
- NCT00039091
- Lead Sponsor
- National Cancer Institute (NCI)
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 26
- 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
- Life expectancy >= 12 weeks
- ECOG performance status of 0, 1 or 2
- Written informed consent
- Due to the unknown effects of MDX-CTLA-4 on the fetus or nursing infant, pregnant or nursing women should not be included; women should be either: post-menopausal for at least 1 year; surgically incapable of bearing children; or utilizing an intrauterine device, and/or spermicide and barrier, for contraception; during the study, use of oral contraception alone is not acceptable; women of childbearing potential must have a negative serum beta-HCG pregnancy test conducted during screening, and a negative urinary beta-HCG pregnancy test conducted within 24 hours prior to treatment; due to the unknown effects of MDX-CTLA-4 on the fetus, men should not father children during the study
- WBC > 1,000 cells/mm^3 (except for AML/MDS patients)
- Serum creatinine < 2 mg/dL
- Platelets > 75,000 cells/mm^3 (except for AML/MDS patients)
- AST and ALT < 2 x UNL
- Total bilirubin < 2 x UNL
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment (ipilimumab) ipilimumab 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.
- Primary Outcome Measures
Name Time Method Toxicities of ipilimumab, based on the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0 Up to 6 years
- Secondary Outcome Measures
Name Time Method 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 90% confidence intervals will be estimated.
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 90% confidence intervals will be estimated.
Trial Locations
- Locations (1)
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States