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| Sponsor: | University of California, San Diego |
|---|---|
| Collaborator: |
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 |
Biological: ipilimumab Biological: therapeutic allogeneic lymphocytes Procedure: adjuvant therapy |
Phase I |
| 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 | |
| Study Chair: | Asad Bashey, MD, PhD | Blood and Marrow Transplant Group of Georgia |
More Information
| Study ID Numbers: | CDR0000301644, UCSD-040749, NCI-6082 |
| Study First Received: | May 6, 2003 |
| Last Updated: | May 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00060372 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
relapsing chronic myelogenous leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia previously treated myelodysplastic syndromes refractory chronic lymphocytic leukemia recurrent adult Hodgkin lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult Burkitt lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma Philadelphia chromosome positive chronic myelogenous leukemia refractory multiple myeloma |
recurrent malignant testicular germ cell tumor stage III malignant testicular germ cell tumor disseminated neuroblastoma recurrent neuroblastoma stage II ovarian epithelial cancer recurrent ovarian epithelial cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian germ cell tumor stage IIIA breast cancer stage IV breast cancer ovarian choriocarcinoma ovarian embryonal carcinoma ovarian yolk sac tumor ovarian immature teratoma |
|
Neuroectodermal Tumors, Primitive Precancerous Conditions Gonadal Disorders Blood Protein Disorders Neoplasms, Nerve Tissue Urogenital Neoplasms Paraproteinemias Ovarian Diseases Hemostatic Disorders Neuroblastoma Genital Diseases, Female Leukemia Preleukemia Pathologic Processes Hemorrhagic Disorders |
Neoplasms by Site Neoplasms, Germ Cell and Embryonal Syndrome Cardiovascular Diseases Lymphoma Breast Diseases Endocrine Gland Neoplasms Disease Ovarian Neoplasms Neoplasms by Histologic Type Immunoproliferative Disorders Skin Diseases Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes |