Humanized Anti-Tac Antibody Therapy In Hodgkin's Disease, A Phase Ib/II Trial
aldesleukin
+ daclizumab
Bone Marrow Diseases+20
+ Chronic Disease
+ Hematologic Diseases
Treatment Study
Summary
Study start date: July 1, 1995
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Beth Israel Deaconess Medical Center
Boston, United StatesOpen Beth Israel Deaconess Medical Center in Google Maps