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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | October 3, 2002 | ||||
| Last Updated Date | July 7, 2009 | ||||
| Start Date ICMJE | September 2002 | ||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Toxicity after every 3 courses of treatment and every month for up to a year after completion of study treatment [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE |
Toxicity after every 3 courses of treatment and every month for up to a year after completion of study treatment | ||||
| Change History | Complete list of historical versions of study NCT00047164 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
T-cell response after every 3 courses of treatment and every month for up to a year after completion of study treatment [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
T-cell response after every 3 courses of treatment and every month for up to a year after completion of study treatment | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Monoclonal Antibody Therapy in Treating Patients With Lymphoma or Colon Cancer That Has Not Responded to Vaccine Therapy | ||||
| Official Title ICMJE | A Pilot Study of Ipilimumab (MDX-CTLA4, MDX-010) in Lymphoma | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Open Label | ||||
| Condition ICMJE | Lymphoma | ||||
| Intervention ICMJE | Biological: ipilimumab | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 89 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Immunologic
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | |||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00047164 | ||||
| Responsible Party | John Edward Janik, NCI - Metabolism Branch;MET | ||||
| Study ID Numbers ICMJE | CDR0000257563, NCI-02-C-0284, NCI-5744 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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