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506U78 in Treating Patients With Refractory Hematologic Cancer

This study is no longer recruiting patients.

Sponsored by: National Cancer Institute (NCI)
Children's Cancer Group
Pediatric Oncology Group
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients with recurrent or refractory hematologic cancer.

Condition Treatment or Intervention Phase
recurrent childhood lymphoblastic lymphoma
T-cell childhood acute lymphoblastic leukemia
recurrent childhood acute lymphoblastic leukemia
 Procedure: chemotherapy
 Drug: U78
 Drug: cytarabine
 Drug: hydrocortisone
 Drug: methotrexate
Phase II

MedlinePlus related topics:  Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Compound 506U78 in Patients with Refractory T-Cell Malignancies

Further Study Details: 

Study start: August 1998

OBJECTIVES: I. Determine the response rate to compound 506U78 (2-amino-9-b-D-arabinofuranosyl-6-methoxy-9H-purine) administered as a 1 hour infusion daily for 5 days in patients with recurrent T-cell malignancies. II. Determine the toxicities of compound 506U78 in this group of patients. III. Correlate the biochemical pharmacology of compound 506U78 (e.g., ara-G nucleotides in leukemic blasts and CSF concentrations) with clinical response. IV. Determine the impact of compound 506U78 therapy on survival and duration of response of patients with recurrent T-cell malignancies.

PROTOCOL OUTLINE: Patients are stratified according to disease characteristics: Group 1: T-cell ALL or NHL in first relapse (greater than 25% bone marrow blasts, with or without concomitant extramedullary relapse other than CNS) Group 2: T-cell ALL or NHL in second or later relapse (greater than 25% bone marrow blasts, with or without concomitant extramedullary relapse other than CNS) Group 3: T-cell ALL or NHL with positive bone marrow and CSF (greater than 5% bone marrow blasts and CNS 2 or 3 involvement) Group 4: Extramedullary relapse and less than 25% blasts in the bone marrow (excluding isolated CNS relapse) Group 1 receives a 1 hour infusion of compound 506U78 daily for 5 days in the absence of neurologic toxicity. The course repeats every 21 days. If a first relapse T-cell ALL study of higher priority is not open, then the patient may continue to receive the drug every 21 days for a maximum of 2 years provided that the patient has achieved a second complete response. Groups 2 and 4 receive compound 506U78 every 21 days for a maximum of 2 years, in the absence of disease progression. After 3 courses a patient may be given CNS prophylaxis with triple intrathecal therapy (TIT), consisting of methotrexate, cytarabine and hydrocortisone after consultation with study coordinator. TIT should be given every 12 weeks. Group 3 receives compound 506U78 every 21 days for a maximum of 2 years, in the absence of disease progression. TIT will be given on day 1 of weeks 1-4, 6, 9 and every 6 weeks for 12 weeks, and then every 9 weeks thereafter. This stratum is open.

PROJECTED ACCRUAL: A maximum of 148 patients (37 patients per stratum) will be accrued for this study.

Eligibility

Ages Eligible for Study:  up to  21 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

Biologic therapy: No concurrent biologic therapy

Chemotherapy:

Endocrine therapy: No concurrent endocrine therapy

Radiotherapy: At least 6 weeks from administration of craniospinal or hemipelvic radiotherapy

Surgery: Not specified

--Patient Characteristics--

Age: 21 and under

Performance status: Karnofsky 50-100%

Life expectancy: At least 8 weeks

Hematopoietic: Not specified

Hepatic:

Renal:

Other: No severe uncontrolled infection


Location Information


Alabama
      MBCCOP - Gulf Coast, Mobile,  Alabama,  36688,  United States

      University of Alabama at Birmingham Comprehensive Cancer Center, Birmingham,  Alabama,  35294-3300,  United States

Arkansas
      University of Arkansas for Medical Sciences, Little Rock,  Arkansas,  72205,  United States

California
      Lucile Packard Children's Hospital at Stanford, Palo Alto,  California,  94304,  United States

      University of California Davis Medical Center, Sacramento,  California,  95817,  United States

      University of California San Diego Cancer Center, La Jolla,  California,  92093-0658,  United States

Connecticut
      Yale Comprehensive Cancer Center, New Haven,  Connecticut,  06520-8028,  United States

District of Columbia
      Walter Reed Army Medical Center, Washington,  District of Columbia,  20307-5000,  United States

Florida
      CCOP - Florida Pediatric, Tampa,  Florida,  33682-7757,  United States

      Miami Children's Hospital, Miami,  Florida,  33155,  United States

      Shands Hospital and Clinics, University of Florida, Gainesville,  Florida,  32610-100277,  United States

      Sylvester Cancer Center, University of Miami, Miami,  Florida,  33136,  United States

Georgia
      Emory University Hospital - Atlanta, Atlanta,  Georgia,  30322,  United States

Hawaii
      Cancer Research Center of Hawaii, Honolulu,  Hawaii,  96813,  United States

Illinois
      Children's Memorial Hospital, Chicago, Chicago,  Illinois,  60614,  United States

Kansas
      CCOP - Wichita, Wichita,  Kansas,  67214-3882,  United States

      University of Kansas Medical Center, Kansas City,  Kansas,  66160-7357,  United States

Louisiana
      CCOP - Ochsner, New Orleans,  Louisiana,  70121,  United States

      MBCCOP - LSU Health Sciences Center, New Orleans,  Louisiana,  70112,  United States

      Ochsner Clinic, New Orleans,  Louisiana,  70121,  United States

Maryland
      Marlene & Stewart Greenebaum Cancer Center, University of Maryland, Baltimore,  Maryland,  21201,  United States

      Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore,  Maryland,  21231-2410,  United States

Massachusetts
      Boston Floating Hospital Infants and Children, Boston,  Massachusetts,  02111,  United States

      Dana-Farber Cancer Institute, Boston,  Massachusetts,  02115,  United States

      University of Massachusetts Memorial Medical Center, Worcester,  Massachusetts,  01655,  United States

Michigan
      Children's Hospital of Michigan, Detroit,  Michigan,  48201,  United States

Mississippi
      University of Mississippi Medical Center, Jackson,  Mississippi,  39216-4505,  United States

Missouri
      Cardinal Glennon Children's Hospital, Saint Louis,  Missouri,  63104,  United States

      Washington University School of Medicine, Saint Louis,  Missouri,  63110,  United States

New Jersey
      CCOP - Northern New Jersey, Hackensack,  New Jersey,  07601,  United States

      Hackensack University Medical Center, Hackensack,  New Jersey,  07601,  United States

      Saint Peter's University Hospital, New Brunswick,  New Jersey,  08901-1780,  United States

      Tomorrows Children's Institute, Hackensack,  New Jersey,  07601,  United States

New York
      Mount Sinai School of Medicine, New York,  New York,  10029,  United States

      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States

      Schneider Children's Hospital, New Hyde Park,  New York,  11042,  United States

      State University of New York - Upstate Medical University, Syracuse,  New York,  13210,  United States

      University of Rochester Cancer Center, Rochester,  New York,  14642,  United States

North Carolina
      Carolinas Medical Center, Charlotte,  North Carolina,  28232-2861,  United States

      Comprehensive Cancer Center at Wake Forest University, Winston Salem,  North Carolina,  27157-1082,  United States

      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States

      East Carolina University School of Medicine, Greenville,  North Carolina,  27858-4354,  United States

      Mission Saint Joseph's Health System, Asheville,  North Carolina,  28801,  United States

      Presbyterian Healthcare, Charlotte,  North Carolina,  28233-3549,  United States

Oklahoma
      Oklahoma Memorial Hospital, Oklahoma City,  Oklahoma,  73126-0307,  United States

Oregon
      CCOP - Columbia River Program, Portland,  Oregon,  97213,  United States

Pennsylvania
      St. Christopher's Hospital for Children, Philadelphia,  Pennsylvania,  19134-1095,  United States

South Carolina
      Children's Hospital of Greenville Hospital System, Greenville,  South Carolina,  29605,  United States

      Medical University of South Carolina, Charleston,  South Carolina,  29425-0721,  United States

Tennessee
      Saint Jude Children's Research Hospital, Memphis,  Tennessee,  38105-2794,  United States

Texas
      Baylor College of Medicine, Houston,  Texas,  77030,  United States

      MBCCOP - South Texas Pediatric, San Antonio,  Texas,  78229-3900,  United States

      Simmons Cancer Center - Dallas, Dallas,  Texas,  75235-9154,  United States

      Texas Children's Cancer Center, Houston,  Texas,  77030-2399,  United States

      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78284-7811,  United States

Virginia
      Cancer Center at the University of Virginia, Charlottesville,  Virginia,  22908,  United States

      Massey Cancer Center, Richmond,  Virginia,  23298-0037,  United States

      Naval Medical Center, Portsmouth, Portsmouth,  Virginia,  23708-2197,  United States

Wisconsin
      Midwest Children's Cancer Center, Milwaukee,  Wisconsin,  53226,  United States

Canada, Alberta
      Cross Cancer Institute, Edmonton,  Alberta,  T6G 1Z2,  Canada

Canada, Ontario
      Children's Hospital, Hamilton,  Ontario,  L8N 3Z5,  Canada

      Hospital for Sick Children, Toronto,  Ontario,  M5G 1X8,  Canada

Canada, Quebec
      Hopital Sainte Justine, Montreal,  Quebec,  H3T 1C5,  Canada

      McGill University Health Center - Montreal Children's Hospital, Montreal,  Quebec,  H3H 1P3,  Canada

Switzerland
      Swiss Pediatric Oncology Group Bern, Bern,  CH 3010,  Switzerland

Study chairs or principal investigators

Stacey L. Berg,  Study Chair,  Pediatric Oncology Group   
W. Archie Bleyer,  Study Chair

More Information

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

Study ID Numbers:  CDR0000065478; POG-9673
Record last reviewed:  August 2003
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002970
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-22
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