Monoclonal Antibody Therapy in Treating Patients With Leukemia

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Calcium; Calcium, Dietary; Daclizumab; Edetic Acid; Pentetic Acid

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adult T-cell leukemia or lymphoma (ATL) of any stage

• Tac expression of malignant cells confirmed by one of the following:

• At least 10% of peripheral blood, lymph node, or dermal malignant cells reactive with anti-Tac by immunofluorescent staining

• Soluble interleukin-2 receptor levels greater than 1,000 U/mL (normal geometric mean = 235; 95% confidence intervals = 112-502 U/mL)

• Measurable disease required

• More than 10% (i.e., strongly Tac-expressing) abnormal cells in peripheral blood considered measurable disease

• All stages of Tac-expressing adult T-cell leukemia are eligible

• 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