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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00047164 |
Purpose
RATIONALE: Monoclonal antibodies such as anti-cytotoxic T-lymphocyte-associated antigen-4 can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: This phase II trial is studying anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody to see how well it works in treating patients with lymphoma or colon cancer that has not responded to vaccine therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: ipilimumab |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Pilot Study of Ipilimumab (MDX-CTLA4, MDX-010) in Lymphoma |
| Estimated Enrollment: | 89 |
| Study Start Date: | September 2002 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a pilot, partial dose-escalation study.
Cohorts of 3-6 patients receive escalating doses of MDX-CTLA4 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.
NOTE: No dose-escalation for lymphoma patients who have previously been treated with an allogeneic stem cell transplantation.
Patients are followed every other month.
PROJECTED ACCRUAL: A total of 89 patients 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:
Histologically confirmed prostate cancer (closed to accrual as of 3/9/2005)
Progressive androgen-independent disease
Histologically confirmed follicular or mantle cell non-Hodgkin's lymphoma (mantle cell lymphoma closed to accrual as of 3/9/2005)
Histologically confirmed colon cancer (colon cancer closed to accrual as of 9/28/05)
Histologically confirmed non-Hodgkin's lymphoma or Hodgkin's lymphoma
Prior allogeneic stem cell transplantation from a matched sibling or matched unrelated donor for an aggressive lymphoma allowed
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
No positive antibody titers to autoimmune diseases
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
No prior anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-CTLA4) for patients in part I of study
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
| Bethesda, Maryland, United States, 20892-1182 | |
| Contact: Patient Recruitment 888-NCI-1937 | |
| Study Chair: | John E. Janik, MD | NCI - Metabolism Branch;MET |
More Information
| Responsible Party: | NCI - Metabolism Branch;MET ( John Edward Janik ) |
| Study ID Numbers: | CDR0000257563, NCI-02-C-0284, NCI-5744 |
| Study First Received: | October 3, 2002 |
| Last Updated: | July 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00047164 History of Changes |
| Health Authority: | Unspecified |
|
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma contiguous stage II adult lymphoblastic lymphoma noncontiguous stage II adult lymphoblastic lymphoma recurrent adult lymphoblastic lymphoma stage I adult lymphoblastic lymphoma stage III adult lymphoblastic lymphoma stage IV adult lymphoblastic lymphoma noncontiguous stage II grade 3 follicular lymphoma recurrent grade 3 follicular lymphoma stage I grade 3 follicular lymphoma stage III grade 3 follicular lymphoma stage IV grade 3 follicular lymphoma contiguous stage II grade 3 follicular lymphoma contiguous stage II grade 2 follicular lymphoma |
contiguous stage II grade 1 follicular lymphoma contiguous stage II adult diffuse mixed cell lymphoma noncontiguous stage II adult diffuse mixed cell lymphoma recurrent adult diffuse mixed cell lymphoma stage I adult diffuse mixed cell lymphoma stage III adult diffuse mixed cell lymphoma stage IV adult diffuse mixed cell lymphoma contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma recurrent adult diffuse large cell lymphoma stage I adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma contiguous stage II adult immunoblastic large cell lymphoma noncontiguous stage II adult immunoblastic large cell lymphoma |
|
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type Immune System Diseases |
Lymphoma, Large-Cell, Immunoblastic Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |