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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 11, 2001 | ||||
| Last Updated Date | July 7, 2009 | ||||
| Start Date ICMJE | April 1997 | ||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Response rate after completion of treatment [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Response rate after completion of treatment | ||||
| Change History | Complete list of historical versions of study NCT00019305 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Survival at 2 years [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Survival at 2 years | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Radiolabeled Monoclonal Antibody Therapy in Treating Adult Patients Who Have Recurrent Hodgkin's Lymphoma or Non-Hodgkin's Lymphoma | ||||
| Official Title ICMJE | Phase I/II of Tac-Expressing Malignancies [Other Than ATL] With Yttrium-90 (90-Y)-Radiolabeled Humanized Anti-Tac and Calcium-DTPA | ||||
| Brief Summary | 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/II trial is studying the side effects and best dose of radiolabeled monoclonal antibody when given together with pentetic acid calcium and to see how well they work in treating patients with recurrent Hodgkin's lymphoma or non-Hodgkin's lymphoma. |
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| Detailed Description | OBJECTIVES:
OUTLINE: This is a dose escalation study. Patients are given yttrium Y 90 labeled humanized anti-Tac monoclonal antibody (Y-HAT) according to an escalating dose schedule along with a fixed dose of pentetic acid calcium (Ca-DTPA) and indium In 111 labeled humanized anti-Tac monoclonal antibody (In-HAT). On day 1, Y-HAT and In-HAT are administered IV over 2 hours followed by a 5 hour infusion of Ca-DTPA. Additional 5 hour infusions of Ca-DTPA are given on days 2 and 3. On day 42 the treatment course may be repeated at the same dosage level. Cohorts of 3 to 6 patients are enrolled at each dose level. Dose escalation continues until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity. After the MTD is defined the phase II portion of the study begins. PROJECTED ACCRUAL: Approximately 55 patients will be accrued in phase I and an additional 30 patients in phase II. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Lymphoma | ||||
| Intervention ICMJE |
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| 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 | 90 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
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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 | NCT00019305 | ||||
| Responsible Party | Thomas A. Waldmann, NCI - Metabolism Branch;MET | ||||
| Study ID Numbers ICMJE | CDR0000065530, NCI-97-C-0110 | ||||
| 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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