Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer

Stopped early · Phase 1

Conditions studied: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), 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 Negative, Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Myeloid Leukemia, Recurrent Melanoma, Recurrent Non-small Cell Lung Cancer, Recurrent Ovarian Epithelial Cancer, Stage IV Melanoma, Stage IV Non-small Cell Lung Cancer

In brief

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

Key facts

Study ID

NCT00039091

Run by

National Cancer Institute (NCI)

People needed

26

Starts

2002-03-01

Expected to finish

2007-11-21

Last updated by the study team

2018-09-05

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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