Monoclonal Antibody Therapy in Treating Patients With Leukemia

NCT ID: NCT00019227

Last Updated: 2013-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1996-10-31
• Study Completion Date: 2006-07-31

Brief Summary

RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody plus pentetic acid calcium in patients with leukemia.

Detailed Description

OBJECTIVES:

• Determine the maximum tolerated dose of yttrium Y 90 daclizumab (90Y daclizumab) when combined with pentetic acid calcium in adults with Tac-expressing T-cell leukemia.
• Determine the therapeutic efficacy and toxicity of this regimen in these patients.
• Monitor patients treated on this regimen for circulating infused antibody (free and labeled) and for the serum concentration of soluble interleukin-2 receptor.
• Evaluate, in a preliminary manner, the immunogenicity of daclizumab.
• Determine the effect of 90Y daclizumab on various components of the circulating cellular immune system.
• Determine whether there is additional urinary excretion of yttrium Y 90 when compared to that observed previously in patients treated without pentetic acid calcium.

OUTLINE: This is a dose escalation study of yttrium Y 90 daclizumab (90Y daclizumab).

Patients receive 90Y daclizumab IV over 2 hours on day 1 and a fixed dose of pentetic acid calcium IV over 5 hours for 3 days. Treatment repeats every 6 weeks for a maximum of 9 courses in the absence of disease progression or circulating antibodies to humanized anti-Tac.

Cohorts of 3-6 patients receive escalating doses of 90Y daclizumab until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Additional patients are treated at the MTD.

Patients are followed at 4-6 weeks.

PROJECTED ACCRUAL: Up to 15 patients will be accrued for the phase I portion of the study. A total of 30 patients will be accrued for the phase II portion of the study.

Conditions

Lymphoma; Radiation Toxicity

Study Design

• Primary Study Purpose: TREATMENT

Interventions

pentetic acid calcium

Intervention Type: DRUG

yttrium Y 90 daclizumab

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Smoldering ATL patients are eligible only if the symptoms and sites of involvement by ATL are such that there is a medical indication to treat

• Smoldering ATL, defined as:

• Lymphocyte count less than 4,000/mm^3
• Less than 5% abnormal lymphocytes on morphologic exam of peripheral blood
• No hypercalcemia
• Lactate dehydrogenase no greater than 1.5 times normal
• No lymphadenopathy
• No involvement of extranodal organs except skin or lung
• No malignant pleural effusion or ascites
• No symptomatic CNS disease due to ATL

• Concurrent diagnosis of tropical spastic paraparesis allowed
• No detectable levels (i.e., greater than 250 ng/mL) of antibody to study drug as assessed by ELISA

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Not specified

Life expectancy:

• Greater than 2 months

Hematopoietic:

• Absolute granulocyte count at least 1,000/mm^3
• Platelet count at least 75,000/mm^3

Hepatic:

• Bilirubin less than 2.0 mg/dL (unless directly due to ATL)
• AST/ALT less than 2.5 times normal

Renal:

• Creatinine less than 1.5 mg/dL OR
• Creatinine clearance greater than 35 mL/min

Cardiovascular:

• No clinical cardiac failure

Pulmonary:

• No symptomatic pulmonary dysfunction unless due to underlying malignancy

Other:

• HIV negative
• Not pregnant or nursing
• Negative pregnancy test

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• At least 4 weeks since prior cytotoxic chemotherapy

Endocrine therapy

• Concurrent corticosteroids allowed

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• Not specified

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Thomas A. Waldmann, MD

Role: STUDY_CHAIR

NCI - Metabolism Branch;MET

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

NCI-96-C-0147K

Identifier Type: -

Identifier Source: secondary_id

CDR0000065240

Identifier Type: -

Identifier Source: org_study_id

NCT00001514

Identifier Type: -

Identifier Source: nct_alias