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| Sponsor: | Dana-Farber Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00039091 |
Purpose
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lung Cancer Melanoma (Skin) Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Ovarian Cancer |
Biological: ipilimumab |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | 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 Prior Vaccine |
| Estimated Enrollment: | 48 |
| Study Start Date: | March 2002 |
| Estimated Primary Completion Date: | July 2003 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Ovarian epithelial cancer
Melanoma
Acute myeloid leukemia (AML) meeting 1 of the following criteria:
Non-small cell lung cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Immunologic
No significant history of autoimmune disease that could be reactivated, including any of the following:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Massachusetts | |
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| Study Chair: | F. Stephen Hodi, MD | Dana-Farber Cancer Institute |
More Information
| Study ID Numbers: | CDR0000069349, DFCI-NCI-5708, NCI-5708 |
| Study First Received: | June 6, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00039091 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent ovarian epithelial cancer recurrent adult acute myeloid leukemia stage IV melanoma recurrent melanoma previously treated myelodysplastic syndromes recurrent non-small cell lung cancer stage IV non-small cell lung cancer |
atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with t(15;17)(q22;q12) |
|
Thoracic Neoplasms Immunologic Factors Precancerous Conditions Gonadal Disorders Physiological Effects of Drugs Neoplasms, Nerve Tissue Urogenital Neoplasms Ovarian Diseases Leukemia, Myeloid, Acute Melanoma Antibodies, Monoclonal Genital Diseases, Female Leukemia Preleukemia Pathologic Processes |
Neoplasms by Site Respiratory Tract Diseases Lung Neoplasms Syndrome Neoplasms, Germ Cell and Embryonal Nevi and Melanomas Endocrine Gland Neoplasms Respiratory Tract Neoplasms Disease Ovarian Neoplasms Neoplasms by Histologic Type Hematologic Diseases Myelodysplastic Syndromes Genital Neoplasms, Female Myeloproliferative Disorders |