Full Text View
Tabular View
No Study Results Posted
Related Studies
Monoclonal Antibody Therapy in Treating Patients With Leukemia
This study has been completed.
Study NCT00019227   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: May 9, 2009   History of Changes

July 11, 2001
May 9, 2009
October 1996
 
 
 
Complete list of historical versions of study NCT00019227 on ClinicalTrials.gov Archive Site
 
 
 
Monoclonal Antibody Therapy in Treating Patients With Leukemia
PHASE I/II STUDY OF TAC-EXPRESSING ADULT T-CELL LEUKEMIA (ATL) WITH YTTRIUM-90 (90Y)-RADIOLABELED HUMANIZED ANTI-TAC AND CALCIUM-DTPA

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.

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.

Phase I, Phase II
Interventional
Treatment
  • Lymphoma
  • Radiation Toxicity
  • Drug: pentetic acid calcium
  • Radiation: yttrium Y 90 daclizumab
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00019227
 
CDR0000065240, NCI-96-C-0147K
National Cancer Institute (NCI)
 
Study Chair: Thomas A. Waldmann, MD NCI - Metabolism Branch;MET
National Cancer Institute (NCI)
March 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP