Humanized Anti-Tac Antibody Therapy In Hodgkin's Disease, A Phase Ib/II Trial
18 Years
N/A
Both
Leukemia, Lymphoma
Trial Information
Humanized Anti-Tac Antibody Therapy In Hodgkin's Disease, A Phase Ib/II Trial
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Richard P. Junghans, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Beth Israel Deaconess Medical Center
Authority:
United States: Federal Government
Study ID:
CDR0000064351
NCT ID:
NCT00002681
Start Date:
July 1995
Completion Date:
December 2003
Related Keywords:
- Leukemia
- Lymphoma
- recurrent adult Hodgkin lymphoma
- recurrent adult acute myeloid leukemia
- relapsing chronic myelogenous leukemia
- chronic phase chronic myelogenous leukemia
- atypical chronic myeloid leukemia, BCR-ABL negative
- Leukemia
- Lymphoma
Name | Location |
|---|---|
| Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
