Expired Study
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Boston, Massachusetts 02215


Purpose:

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Interleukin-2 may stimulate a person's white blood cells to kill leukemia or lymphoma cells. Combining these two therapies may be an effective treatment for leukemia and lymphoma. PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy plus interleukin-2 in treating patients who have leukemia or lymphoma.


Study summary:

OBJECTIVES: - Assess the safety and tolerability of a multidose regimen of humanized anti-Tac monoclonal antibody (HAT) and interleukin-2 (IL-2) in patients with leukemia and lymphoma. - Describe the pharmacokinetics/pharmacodynamics of HAT and IL-2 in a multidose schedule, including serum half-life of free HAT, area under the curve, and volume of distribution. - Evaluate the immunogenicity of HAT. - Identify immunologic parameters that correlate with efficacy. - Evaluate the preliminary efficacy of HAT in these patients. - Monitor patients receiving indium-111-labeled HAT for circulating infused antibody for pharmacokinetics, tumor imaging, and bioactivity (binding ability). OUTLINE: Patients are stratified according to disease (Hodgkin's lymphoma vs acute myelogenous leukemia vs chronic myelogenous leukemia). Patients receive humanized anti-TAC monoclonal antibody (HAT) IV over 30 minutes on day 1, then IV over 30 minutes every 7 days and interleukin-2 subcutaneously daily. Treatment continues for up to 1 year in the absence of disease progression, unacceptable toxicity, or development of neutralizing antibodies. Patients are followed weekly for 2 months. PROJECTED ACCRUAL: A total of 25 patients with Hodgkin's lymphoma and 14 each with AML and CML will be accrued for this study.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed diagnosis of one of the following malignancies: - Hodgkin's lymphoma - Acute myelogenous leukemia - Chronic myelogenous leukemia - Failed standard therapy or in chronic phase if on standard therapy - At least 30% of malignant cells reactive with anti-Tac as determined by immunofluorescence studies - All Hodgkin's lymphoma patients eligible due to 100% Tac-positivity of Reed-Sternberg cells - Measurable disease - No symptomatic CNS disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - 0-2 Life expectancy: - Greater than 2 months Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 3 times normal - No significant hepatic disease Renal: - Creatinine no greater than 3 times normal - No significant renal disease Cardiovascular: - No significant cardiovascular disease Pulmonary: - No significant pulmonary disease Other: - No significant endocrine, rheumatologic, or allergic disease - No HIV-I antibody - No active disease due to any of the following: - Cytomegalovirus Herpes simplex virus I/II - Hepatitis B or C Tuberculosis - Negative pregnancy test required of fertile women PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior murine anti-Tac monoclonal antibody Chemotherapy: - At least 4 weeks since chemotherapy Endocrine therapy: - Not specified Radiotherapy: - At least 4 weeks since radiotherapy Surgery: - Not specified Other: - Concurrent treatment allowed for complications of primary disease


NCT ID:

NCT00002681


Primary Contact:

Study Chair
Richard P. Junghans, MD, PhD
Beth Israel Deaconess Medical Center


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02215
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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