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Humanized Anti-Tac Antibody Therapy In Hodgkin's Disease, A Phase Ib/II Trial


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphoma

Thank you

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 CenterBoston, Massachusetts  02215