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Home > "M" Clinical Trials Conditions > Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or Lymphoma  Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or Lymphoma
Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or Lymphoma
For Condition: recurrent adult Hodgkin's lymphoma,recurrent adult acute myeloid leukemia,relapsing chronic myelogenous leukemia,chronic phase chronic myelogenous leukemia,atypical chronic myeloid leukemia
Status: No longer recruiting
Sponsor(s): Beth Israel Deaconess Medical Center , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardJunghans, Study Chair, Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Additional Information:
Study ID Numbers: CDR0000064351; BIDMC-92020534,NEDH-92020534,BIDMC-FDR001054,NCI-H95-0732
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002681
Other Chronic Phase Chronic Myelogenous Leukemia Studies:
1. Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Relapsed Hodgkin's Lymphoma
2. Rituximab in Treating Patients With Hodgkin's Lymphoma
3. Monoclonal Antibody Therapy in Treating Patients With Refractory Anaplastic Large Cell Lymphoma or Hodgkin's Lymphoma
4. MDX-060 Monoclonal Antibody in Treating Patients With Refractory or Relapsed Lymphoma
5. Monoclonal Antibody Therapy in Treating Patients With Recurrent Hodgkin's Lymphoma
Related Studies:
Other chronic phase chronic myelogenous leukemia Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or Lymphoma
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