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506U78 in Treating Patients With Refractory Hematologic Cancer
This study is ongoing, but not recruiting participants.
Study NCT00002970   Information provided by National Cancer Institute (NCI)
First Received: November 1, 1999   Last Updated: July 23, 2008   History of Changes

November 1, 1999
July 23, 2008
June 1997
 
 
 
Complete list of historical versions of study NCT00002970 on ClinicalTrials.gov Archive Site
 
 
 
506U78 in Treating Patients With Refractory Hematologic Cancer
A Phase II Study of Compound 506U78 in Patients With Refractory T-Cell Malignancies - POG/CCG Intergroup Study

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.

OBJECTIVES:

  • 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.
  • Determine the toxicities of compound 506U78 in this group of patients.
  • Correlate the biochemical pharmacology of compound 506U78 (e.g., ara-G nucleotides in leukemic blasts and CSF concentrations) with clinical response.
  • Determine the impact of compound 506U78 therapy on survival and duration of response of patients with recurrent T-cell malignancies.

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

  • Patients receive 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

  • Patients 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

  • Patients receive 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.

Phase II
Interventional
Primary Purpose:  Treatment
  • Leukemia
  • Lymphoma
  • Drug: cytarabine
  • Drug: methotrexate
  • Drug: nelarabine
  • Drug: therapeutic hydrocortisone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
148
 
 

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

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

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
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Switzerland
 
NCT00002970
 
CDR0000065478, POG-9673, CCG-P9673
Pediatric Oncology Group
  • National Cancer Institute (NCI)
  • Children's Cancer Group
Study Chair: Stacey L. Berg, MD Texas Children's Cancer Center
Study Chair: Gregory H. Reaman, MD Children's Research Institute
National Cancer Institute (NCI)
October 2007

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