Expired Study
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Bethesda, Maryland 20892


Purpose:

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/II trial to study the effectiveness of radiolabeled monoclonal antibody plus pentetic acid calcium in patients with leukemia.


Study summary:

OBJECTIVES: - Determine the maximum tolerated dose of yttrium Y 90 daclizumab (90Y daclizumab) when combined with pentetic acid calcium in adults with Tac-expressing T-cell leukemia. - Determine the therapeutic efficacy and toxicity of this regimen in these patients. - Monitor patients treated on this regimen for circulating infused antibody (free and labeled) and for the serum concentration of soluble interleukin-2 receptor. - Evaluate, in a preliminary manner, the immunogenicity of daclizumab. - Determine the effect of 90Y daclizumab on various components of the circulating cellular immune system. - Determine whether there is additional urinary excretion of yttrium Y 90 when compared to that observed previously in patients treated without pentetic acid calcium. OUTLINE: This is a dose escalation study of yttrium Y 90 daclizumab (90Y daclizumab). Patients receive 90Y daclizumab IV over 2 hours on day 1 and a fixed dose of pentetic acid calcium IV over 5 hours for 3 days. Treatment repeats every 6 weeks for a maximum of 9 courses in the absence of disease progression or circulating antibodies to humanized anti-Tac. Cohorts of 3-6 patients receive escalating doses of 90Y daclizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Additional patients are treated at the MTD. Patients are followed at 4-6 weeks. PROJECTED ACCRUAL: Up to 15 patients will be accrued for the phase I portion of the study. A total of 30 patients will be accrued for the phase II portion of the study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed adult T-cell leukemia or lymphoma (ATL) of any stage - Tac expression of malignant cells confirmed by one of the following: - At least 10% of peripheral blood, lymph node, or dermal malignant cells reactive with anti-Tac by immunofluorescent staining - Soluble interleukin-2 receptor levels greater than 1,000 U/mL (normal geometric mean = 235; 95% confidence intervals = 112-502 U/mL) - Measurable disease required - More than 10% (i.e., strongly Tac-expressing) abnormal cells in peripheral blood considered measurable disease - All stages of Tac-expressing adult T-cell leukemia are eligible - Smoldering ATL patients are eligible only if the symptoms and sites of involvement by ATL are such that there is a medical indication to treat - Smoldering ATL, defined as: - Lymphocyte count less than 4,000/mm^3 - Less than 5% abnormal lymphocytes on morphologic exam of peripheral blood - No hypercalcemia - Lactate dehydrogenase no greater than 1.5 times normal - No lymphadenopathy - No involvement of extranodal organs except skin or lung - No malignant pleural effusion or ascites - No symptomatic CNS disease due to ATL - Concurrent diagnosis of tropical spastic paraparesis allowed - No detectable levels (i.e., greater than 250 ng/mL) of antibody to study drug as assessed by ELISA PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Not specified Life expectancy: - Greater than 2 months Hematopoietic: - Absolute granulocyte count at least 1,000/mm^3 - Platelet count at least 75,000/mm^3 Hepatic: - Bilirubin less than 2.0 mg/dL (unless directly due to ATL) - AST/ALT less than 2.5 times normal Renal: - Creatinine less than 1.5 mg/dL OR - Creatinine clearance greater than 35 mL/min Cardiovascular: - No clinical cardiac failure Pulmonary: - No symptomatic pulmonary dysfunction unless due to underlying malignancy Other: - HIV negative - Not pregnant or nursing - Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 4 weeks since prior cytotoxic chemotherapy Endocrine therapy - Concurrent corticosteroids allowed Radiotherapy - Not specified Surgery - Not specified Other - Not specified


NCT ID:

NCT00019227


Primary Contact:

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


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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