Bethesda, Maryland 20892


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.


Study summary:

OBJECTIVES: - Assess the toxicity and therapeutic efficacy of yttrium Y 90 radiolabeled humanized anti-Tac (HAT) monoclonal antibody in patients with Tac expressing hematologic malignancies. - Define the pharmacokinetics of indium In 111 and yttrium Y 90 HAT monoclonal antibodies. 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.


Criteria:

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: - Stages II-IV that relapsed or failed to achieve complete remission after first line chemotherapy, and not eligible for or refused salvage chemotherapy or bone marrow transplantation PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 50-100% Life expectancy: - Greater than 1 month Hematopoietic: - Granulocyte count at least 1,200/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - SGOT and SGPT less than 5 times upper limit of normal (ULN) - Bilirubin less than 3 times ULN Renal: - Creatinine less than 2.0 mg/dL OR - Creatinine clearance greater than 50 mL/min Cardiovascular: - No clinical evidence of cardiac failure Pulmonary: - No symptomatic pulmonary dysfunction unless due to malignancy Other: - Not pregnant or nursing - Negative pregnancy test - HIV negative - No active second primary malignancy other than basal cell skin cancer - No symptomatic disease due to CNS involvement PRIOR CONCURRENT THERAPY: Biologic therapy: - No anticoagulant therapy Chemotherapy: - At least 3 weeks since prior chemotherapy - No concurrent chemotherapy Endocrine therapy: - Corticosteroids allowed if dose is stable for at least 3 weeks Radiotherapy: - At least 3 weeks since prior radiotherapy - No concurrent radiotherapy Surgery: - Not specified


NCT ID:

NCT00019305


Primary Contact:

Study Chair
Thomas A. Waldmann, MD
NCI - Metabolism Branch;MET


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States

Clinical Trials Office - Warren Grant Magnusen Clinical Center
Phone: 888-NCI-1937

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 21, 2017

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