Clinical trial · Interventional
Monoclonal Antibody Therapy in Treating Patients With Ovarian Epithelial Cancer, Melanoma, Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Non-Small Cell Lung Cancer
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
NCT00039091CI-TRIAL-00034713terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (14)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) | — | UNRESOLVED | — |
| Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) | Adult Acute Myeloid Leukemia with t(16;16)(p13.1;q22); CBFB-MYH11 | ALIAS | 0.90 |
| Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) | Acute Myeloid Leukemia with t(8;21)(q22;q22.1); RUNX1-RUNX1T1 | ALIAS | 0.85 |
| Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative | Atypical Chronic Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ipilimumab | Biological | Ipilimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (ipilimumab)
- description
- 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.
- interventionNames
- Biological: ipilimumab
Primary outcomes (1)
- measure
- Toxicities of ipilimumab, based on the National Cancer Institute Common Toxicity Criteria (NCI CTC) v2.0
- timeFrame
- Up to 6 years
Secondary outcomes (2)
- measure
- Overall clinical response rate (complete response [CR] plus partial response [PR]) based on the Response Evaluation Criteria in Solid Tumors (RECIST)
- timeFrame
- Up to 6 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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 * 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 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
References
Publications (0)
Data not yet available
No reference posted for this study.