Trials / Terminated
TerminatedNCT00039091
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
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- 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
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | ipilimumab | Given IV |
Timeline
- Start date
- 2002-03-01
- Primary completion
- 2007-11-01
- Completion
- 2007-11-21
- First posted
- 2003-01-27
- Last updated
- 2018-09-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00039091. Inclusion in this directory is not an endorsement.