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| Tracking Information | |||||
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| First Received Date ICMJE | July 5, 2000 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | April 2001 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00006009 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Monoclonal Antibody Therapy in Treating Patients With Advanced or Recurrent Lymphoma | ||||
| Official Title ICMJE | A Phase I, Multiple Dose Escalation Trial of Intravenous Humanized Anti-CD3 Antibody (HuM291) in Patients With CD3+ T-Cell Lymphomas | ||||
| Brief Summary | RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I trial to study the effectiveness of monoclonal antibody therapy in treating patients who have advanced or recurrent lymphoma. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a dose-escalation study. Patients receive monoclonal antibody HuM291 IV over 3 hours on days 1-4 in the absence of unacceptable toxicity. Patients achieving a partial response, complete response with recurrence, or stable disease may receive further therapy. Cohorts of 3-6 patients receive escalating doses of monoclonal antibody HuM291 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed weekly for 1 month and then monthly for 3 months. PROJECTED ACCRUAL: A total of 12-15 patients will be accrued for this study. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE |
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| Intervention ICMJE | Biological: monoclonal antibody HuM291 | ||||
| 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 | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
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 | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00006009 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068017, SUMC-NCI-102, NCI-102 | ||||
| Study Sponsor ICMJE | Stanford University | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | April 2003 | ||||
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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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