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| Sponsors and Collaborators: |
University of California, San Diego National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00060372 |
Purpose
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: This phase I trial is studying how well monoclonal antibody therapy works after allogeneic stem cell transplantation in treating patients with persistent or progressive cancer.
| Condition | Intervention | Phase |
|
Breast Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Neuroblastoma Ovarian Cancer Testicular Germ Cell Tumor |
Drug: ipilimumab Drug: therapeutic allogeneic lymphocytes Procedure: adjuvant therapy |
Phase I |
| Genetics Home Reference related topics: | aceruloplasminemia breast cancer hemophilia |
| MedlinePlus related topics: | Breast Cancer Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma Neuroblastoma Ovarian Cancer |
| ChemIDplus related topics: | Ipilimumab Cytotoxic T-lymphocyte antigen 4 |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | CTLA-4 Blockade With MDX-010 To Induce Graft - Versus - Malignancy Effects Following Allogeneic Hematopoietic Stem Cell Transplantation |
| Estimated Enrollment: | 21 |
| Study Start Date: | April 2003 |
| Estimated Primary Completion Date: | February 2004 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes.
Cohorts of 3-6 patients receive escalating doses of MDX-010 until the maximum tolerated dose (MTD) is determined. The MTD is the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients with persistent or progressive disease at 60 days after MDX-010 administration and no evidence of graft-versus-host disease receive donor lymphocyte infusions every 60 days for a total of 3 infusions.
Patients are followed at 4, 5, 6, 9, and 12 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 18-21 patients will be accrued for this study within 24-30 months.
Eligibility
| Ages Eligible for Study: | 14 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of persistent or progressive hematologic malignancy or solid tumor after allogeneic hematopoietic stem cell transplantation (AHSCT)
The following malignancies are eligible:
Chronic myelogenous leukemia (CML) meeting the following criteria:
Cytogenetic progression or persistence as evidenced by 1 of the following:
Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that meets any of the following criteria:
Myelodysplastic syndromes that meet any of the following criteria:
Chronic lymphocytic leukemia that meets any of the following criteria:
Agressive non-Hodgkin's lymphoma (e.g., diffuse large cell lymphoma, lymphoblastic lymphoma, mantle cell lymphoma, or peripheral T cell lymphoma), Hodgkin's lymphoma, OR solid tumor that meets any of the following criteria:
Multiple myeloma with demonstrated resistance to or intolerance of prior thalidomide and bortezomib unless these agents are contraindicated (e.g., due to peripheral neuropathy) and meeting any of the following criteria:
Measurable or evaluable disease
At least 50% donor chimerism in the T-cell lineage OR full (≥ 90%) donor chimerism in unseparated blood on last assessment within 3 months before study entry
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
No concurrent autoimmune diseases requiring the chronic use of immunosuppressive medications
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, California | |||||
| Ida M. and Cecil H. Green Cancer Center at Scripps Clinic | |||||
| La Jolla, California, United States, 92037-1027 | |||||
| Rebecca and John Moores UCSD Cancer Center | |||||
| La Jolla, California, United States, 92093-0658 | |||||
| United States, Georgia | |||||
| Blood and Marrow Transplant Group of Georgia | |||||
| Atlanta, Georgia, United States, 30342 | |||||
| Northside Hospital Cancer Center | |||||
| Atlanta, Georgia, United States, 30342-1611 | |||||
| United States, Massachusetts | |||||
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |||||
| Boston, Massachusetts, United States, 02115 | |||||
| University of California, San Diego |
| National Cancer Institute (NCI) |
| Study Chair: | Asad Bashey, MD, PhD | Blood and Marrow Transplant Group of Georgia |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000301644, UCSD-040749, NCI-6082 |
| First Received: | May 6, 2003 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00060372 |
| Health Authority: | United States: Food and Drug Administration |
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