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Home > "5" Clinical Trials Conditions > 506U78 in Treating Patients With Refractory Hematologic Cancer  506U78 in Treating Patients With Refractory Hematologic Cancer
506U78 in Treating Patients With Refractory Hematologic Cancer
For Condition: recurrent childhood acute lymphoblastic leukemia,recurrent childhood lymphoblastic lymphoma,T-cell childhood acute lymphoblastic leukemia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Children's Cancer Group,Pediatric Oncology Group
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Refractory or recurrent acute lymphocytic leukemia (ALL) or non-Hodgkin's lymphoma (NHL) with bone marrow involvement (T-cell disease only) - Isolated CNS relapse not eligible --Prior/Concurrent Therapy-- Biologic therapy: No concurrent biologic therapy Chemotherapy: - Recovered from toxic effects - At least 6 weeks from administration of nitrosoureas 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: - Bilirubin no greater than 1.5 mg/dL - SGPT less than 5 times normal Renal: - Creatinine normal for age - Creatinine clearance or GFR at least 60 mL/min/1.73m2 Other: No severe uncontrolled infection
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StaceyBerg, Study Chair, Pediatric Oncology Group
Tomorrows Children's Institute
Hackensack, New Jersey, 07601
United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, 38105-2794
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
MBCCOP - South Texas Pediatric
San Antonio, Texas, 78229-3900
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
MBCCOP - Gulf Coast
Mobile, Alabama, 36688
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Oklahoma Memorial Hospital
Oklahoma City, Oklahoma, 73126-0307
United States
East Carolina University School of Medicine
Greenville, North Carolina, 27858-4354
United States
Naval Medical Center, Portsmouth
Portsmouth, Virginia, 23708-2197
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
Swiss Pediatric Oncology Group Bern
BERN, , CH 3010
Switzerland
Texas Children's Cancer Center
Houston, Texas, 77030-2399
United States
Mission Saint Joseph's Health System
Asheville, North Carolina, 28801
United States
State University of New York - Upstate Medical University
Syracuse, New York, 13210
United States
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
United States
Children's Memorial Hospital, Chicago
Chicago, Illinois, 60614
United States
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Canada
Miami Children's Hospital
Miami, Florida, 33155
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Cancer Research Center of Hawaii
Honolulu, Hawaii, 96813
United States
Mount Sinai School of Medicine
New York City, New York, 10029
United States
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, 32610-100277
United States
Children's Hospital
Hamilton, Ontario, L8N 3Z5
Canada
CCOP - Columbia River Program
Portland, Oregon, 97213
United States
Schneider Children's Hospital
New Hyde Park, New York, 11042
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
University of Rochester Cancer Center
Rochester, New York, 14642
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7357
United States
Ochsner Clinic
New Orleans, Louisiana, 70121
United States
Cardinal Glennon Children's Hospital
St. Louis, Missouri, 63104
United States
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Canada
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
United States
Massey Cancer Center
Richmond, Virginia, 23298-0037
United States
CCOP - Florida Pediatric
Tampa, Florida, 33682-7757
United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Presbyterian Healthcare
Charlotte, North Carolina, 28233-3549
United States
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134-1095
United States
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
United States
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, 29605
United States
Hopital Sainte Justine
Montreal, Quebec, H3T 1C5
Canada
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
University of California Davis Medical Center
Sacramento, California, 95817
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
University of California San Diego Cancer Center
La Jolla, California, 92093-0658
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
United States
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, H3H 1P3
Canada
Boston Floating Hospital Infants and Children
Boston, Massachusetts, 02111
United States
Midwest Children's Cancer Center
Milwaukee, Wisconsin, 53226
United States
Saint Peter's University Hospital
New Brunswick, New Jersey, 08901-1780
United States
CCOP - Ochsner
New Orleans, Louisiana, 70121
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Additional Information:
Study ID Numbers: CDR0000065478; POG-9673
Study Start Date: August 1998
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002970
Other Recurrent Childhood Acute Lymphoblastic Leukemia Studies:
1. 506U78 in Treating Patients With Refractory Hematologic Cancer
2. 506U78 in Treating Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
3. Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
4. Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia
Related Studies:
Other recurrent childhood acute lymphoblastic leukemia Clinical Trials
Other Ontario Clinical Trials
Other Hamilton Clinical Trials
506U78 in Treating Patients With Refractory Hematologic Cancer
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