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| Sponsored by: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00019305 |
Purpose
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.
| Condition | Intervention | Phase |
|
Lymphoma Radiation Toxicity |
Drug: daclizumab Drug: pentetic acid calcium |
Phase I Phase II |
| MedlinePlus related topics: | Cancer Hodgkin's Disease Lymphoma |
| ChemIDplus related topics: | Calcium gluconate Pentetic acid Calcium DTPA Calcium trisodium pentetate Zinc-DTPA Dacliximab |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I/II of Tac-Expressing Malignancies [Other Than ATL] With Yttrium-90 (90-Y)-Radiolabeled Humanized Anti-Tac and Calcium-DTPA |
| Estimated Enrollment: | 55 |
| Study Start Date: | April 1997 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Must meet the following disease specific criteria:
Non-Hodgkin's lymphoma (NHL)
Hodgkin's lymphoma
Cutaneous T-cell lymphoma
Peripheral T-cell lymphoma
Other lymphoid leukemia or lymphoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Maryland | |||||
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting | ||||
| Bethesda, Maryland, United States, 20892-1182 | |||||
| Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |||||
| Study Chair: | Thomas A. Waldmann, MD | NCI - Metabolism Branch;MET |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000065530, NCI-97-C-0110Q |
| First Received: | July 11, 2001 |
| Last Updated: | May 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00019305 |
| Health Authority: | Unspecified |
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