![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00089076 |
RATIONALE: Biological therapies, such as MDX-010, work in different ways to stimulate the immune system and stop cancer cells from growing.
PURPOSE: This phase I/II trial is studying the side effects and best dose of MDX-010 and to see how well it works in treating patients with recurrent or refractory B-cell non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: ipilimumab |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase I/II Study Of Anti CTLA-4 Monoclonal Antibody (MDX-010) In B-Cell Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 36 |
Study Start Date: | July 2004 |
Estimated Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, open-label, phase I, dose-escalation study followed by a phase II study. Patients are grouped according to prior treatment with a vaccine therapy for lymphoma (yes vs no).
Cohorts of 6 patients from each group receive escalating doses of MDX-010 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 12-36 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed B-cell lymphoma
Recurrent or refractory disease after ≥ 1 prior conventional therapy, including chemotherapy or monoclonal antibody therapy
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Immunologic
No history of autoimmune disease requiring systemic therapy with immunosuppressive drugs, including, but not limited to, any of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Jonsson Comprehensive Cancer Center at UCLA | |
Los Angeles, California, United States, 90095-1781 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 |
Study Chair: | Stephen M. Ansell, MD, PhD | Mayo Clinic |
Study ID Numbers: | CDR0000378036, MAYO-MC0312, NCI-6359, UCLA-0406055-01 |
Study First Received: | August 4, 2004 |
Last Updated: | January 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00089076 |
Health Authority: | United States: Food and Drug Administration |
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma stage IV adult diffuse large cell lymphoma |
stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma stage IV grade 3 follicular lymphoma stage IV mantle cell lymphoma stage IV marginal zone lymphoma recurrent grade 3 follicular lymphoma recurrent adult immunoblastic large cell lymphoma stage IV adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma stage IV adult lymphoblastic lymphoma |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Lymphoma, Mantle-Cell Lymphoma, Follicular Lymphoma, small cleaved-cell, diffuse Lymphoblastic lymphoma Mantle cell lymphoma Cytotoxic T-lymphocyte antigen 4 Lymphoma, large-cell, immunoblastic Recurrence Antibodies, Monoclonal |
Lymphoma, large-cell Lymphoma, B-Cell Lymphatic Diseases Antibodies B-cell lymphomas Lymphoma, Large-Cell, Immunoblastic Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Follicular lymphoma Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |