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A Multicenter Study to Assess the Efficacy of 506U78 in Patients With Chronic Lymphocytic Leukemia Who Are Refractory to Fludarabine and Alkylator Therapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia

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Trial Information

A Multicenter Study to Assess the Efficacy of 506U78 in Patients With Chronic Lymphocytic Leukemia Who Are Refractory to Fludarabine and Alkylator Therapy


OBJECTIVES: I. Determine the anticancer efficacy of 506U78 in patients with chronic
lymphocytic leukemia refractory to fludarabine and alkylator therapy. II. Determine the
safety (including incidence of infection) of this drug in these patients. III. Evaluate the
pharmacokinetics of 506U78 and ara-G, and assess the intracellular pharmacokinetics of
ara-GTP in patients receiving multiple treatment courses (at M.D. Anderson Cancer Center
only). IV. Determine the response rate, time to maximal response, and duration of response
in patients treated with this drug. V. Determine two-year survival and progression-free
survival of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to cellular type of
disease (B cell vs T cell). Patients receive 506U78 IV over 2 hours on days 1, 3, and 5.
Treatment repeats every 28 days for a maximum of 8 courses in the absence of disease
progression or unacceptable toxicity. Patients are followed at 28 days and then every 2
months for 2 years until disease progression. After disease progression, patients are
followed every 3 months for 2 years.

PROJECTED ACCRUAL: Approximately 14-100 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Diagnosis of refractory chronic lymphocytic leukemia Evidence of
active disease after fludarabine or alkylator therapy Must meet one or more of the
following criteria for active disease: Minimum of one of the following disease-related
symptoms: Weight loss of 10% or more within the previous 6 months Extreme fatigue (e.g.,
unable to work or perform usual activities) Fevers greater than 100.5 degrees F for 2
weeks or more without evidence of infection Night sweats without evidence of infection
Evidence of progressive marrow failure manifested by the development or worsening of
autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroid
therapy Massive (e.g., greater than 6 cm below the left costal margin) or progressive
splenomegaly Massive nodes or clusters (e.g., greater than 10 cm in longest diameter) or
progressive lymphadenopathy Progressive lymphocytosis with an increase of more than 50%
over a 2-month period or an anticipated doubling time of less than 6 months Ineligible if
marked hypogammaglobulinemia or development of monoclonal protein in the absence of the
above criteria for active disease Must have one of the following resulting from prior
fludarabine or alkylator-containing therapy: Disease progression during therapy Failure to
respond or obtained less than a partial response to therapy Disease progression within 6
months of the last course of therapy after an initial response Failure to respond or
disease progression allowed at any time after the final dose if alkylator agent was not
the most recent therapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life
expectancy: At least 12 weeks Hematopoietic: See Disease Characteristics Hepatic: See
Disease Characteristics Bilirubin no greater than 2 times upper limit of normal No liver
dysfunction due to organ infiltration by lymphocytes Renal: Creatinine clearance at least
50 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception during and for up to 28 days after study No neurotoxicity of grade
2 or higher No history of significant neurologic toxicity (grade 2 or greater motor or
sensory impairment) due to prior chemotherapy or radiotherapy No history of seizure
disorder No active infection No other malignancy within the past 2 years (except
adequately treated non- melanomatous skin cancer or carcinoma in situ) that would preclude
study No systemic nonmalignant comorbid disease that would preclude study No
psychological, sociological, or geographical condition that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow or peripheral blood stem
cell transplantation Recovered from prior immunotherapy At least 4 weeks since prior
biologic therapy and recovered Concurrent growth factors allowed Chemotherapy: See Disease
Characteristics At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or
mitomycin) and recovered No prior 506U78 therapy No other concurrent chemotherapy
Endocrine therapy: See Disease Characteristics No concurrent corticosteroid therapy
greater than 10 mg/day of prednisone equivalent No concurrent corticosteroids as
antiemetics Concurrent hormone replacement therapy or oral contraceptives allowed
Concurrent hydrocortisone as prophylaxis or treatment of transfusion reactions allowed
Radiotherapy: At least 4 weeks since prior radiotherapy and recovered No concurrent
radiotherapy Surgery: Not specified Other: No other concurrent anticancer agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Tonya M. Peele, MS

Investigator Role:

Study Chair

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Federal Government

Study ID:

CDR0000066719

NCT ID:

NCT00003635

Start Date:

January 1999

Completion Date:

Related Keywords:

  • Leukemia
  • refractory chronic lymphocytic leukemia
  • T-cell large granular lymphocyte leukemia
  • B-cell chronic lymphocytic leukemia
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
University of Chicago Cancer Research CenterChicago, Illinois  60637
Johns Hopkins Oncology CenterBaltimore, Maryland  21287
Washington University School of MedicineSaint Louis, Missouri  63110
Ireland Cancer CenterCleveland, Ohio  44106-5065
Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Holden Comprehensive Cancer Center at The University of IowaIowa City, Iowa  52242-1009
Lombardi Cancer CenterWashington, District of Columbia  20007
Cedars-Sinai Medical CenterLos Angeles, California  90048
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Scripps ClinicLa Jolla, California  92037
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
Sidney Kimmel Cancer CenterSan Diego, California  92121
Greenville Hospital SystemGreenville, South Carolina  29605
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Medicine BranchBethesda, Maryland  20892
Clinical Studies, Ltd.Denver, Colorado  80222
Physician Reliance Network, Inc.Dallas, Texas  75246