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| Sponsor: | 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 |
Biological: daclizumab Drug: pentetic acid calcium |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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: | 95 |
| Study Start Date: | April 1997 |
| Estimated Primary Completion Date: | December 2009 (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. Treatment may repeat every 6 weeks for up to 7 courses.
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 65 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:
Histologically confirmed Hodgkin's lymphoma, non-Hodgkin's lymphoma, or lymphoid leukemia with at least 10% of malignant cells reacting with anti-Tac monoclonal antibody (waived for Hodgkin's lymphoma)
Hodgkin's lymphoma meeting the following criteria:
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
| Responsible Party: | NCI - Metabolism Branch;MET ( Thomas A. Waldmann ) |
| Study ID Numbers: | CDR0000065530, NCI-97-C-0110 |
| Study First Received: | July 11, 2001 |
| Last Updated: | February 4, 2010 |
| ClinicalTrials.gov Identifier: | NCT00019305 History of Changes |
| Health Authority: | Unspecified |
|
recurrent adult Hodgkin lymphoma recurrent mycosis fungoides/Sezary syndrome recurrent small lymphocytic lymphoma |
splenic marginal zone lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma stage IV mycosis fungoides/Sezary syndrome |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Daclizumab Physiological Effects of Drugs Iron Chelating Agents Immunosuppressive Agents Protective Agents |
Pharmacologic Actions Pentetic Acid Lymphatic Diseases Neoplasms Chelating Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Hodgkin Disease Lymphoma Antidotes |