Clinical trial NCT00002681: Monoclonal Antibody Plus Interleukin-2 in Treating Patients With Leukemia or Lymphoma
Official title: Humanized Anti-Tac Antibody Therapy In Hodgkin's Disease, A Phase Ib/II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Leukemia
Lymphoma
Keywords: 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
Lead sponsor: Roger Williams Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Beth Israel Deaconess Medical Center
First posted: 2003-01-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Richard P. Junghans, MD, PhD
role: STUDY_CHAIR
References: