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Monoclonal Antibody Therapy in Treating Patients With Leukemia

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma; Radiation Toxicity

Intervention: pentetic acid calcium (Drug); yttrium Y 90 daclizumab (Radiation)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: National Cancer Institute (NCI)

Official(s) and/or principal investigator(s):
Thomas A. Waldmann, MD, Study Chair, Affiliation: NCI - Metabolism Branch;MET

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.

Clinical Details

Official title: PHASE I/II STUDY OF TAC-EXPRESSING ADULT T-CELL LEUKEMIA (ATL) WITH YTTRIUM-90 (90Y)-RADIOLABELED HUMANIZED ANTI-TAC AND CALCIUM-DTPA

Study design: Primary Purpose: Treatment

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland 20892-1182, United States
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: October 1996
Last updated: June 19, 2013

Page last updated: August 23, 2015

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