ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
506U78 in Treating Patients With Refractory Hematologic Cancer

This study is ongoing, but not recruiting participants.
Study NCT00002970.   Last updated on July 23, 2008.   Information provided by National Cancer Institute (NCI)

This Tabular View shows the required WHO registration data elements as marked by

Descriptive Information Fields
Brief Title  506U78 in Treating Patients With Refractory Hematologic Cancer
Official Title  A Phase II Study of Compound 506U78 in Patients With Refractory T-Cell Malignancies - POG/CCG Intergroup Study
Brief Summary

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.

Detailed Description

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.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Leukemia
Lymphoma
Intervention  Drug: cytarabine
Drug: methotrexate
Drug: nelarabine
Drug: therapeutic hydrocortisone
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  148
Start Date  June 1997
Completion Date
Eligibility 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

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
Gender Both
Ages up to 21 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Canada,   Switzerland
Administrative Information Fields
NCT ID  NCT00002970
Organization ID CDR0000065478
Secondary IDs †† POG-9673, CCG-P9673
Study Sponsor  Pediatric Oncology Group
Collaborators †† National Cancer Institute (NCI)
Children's Cancer Group
Investigators 
Study Chair:     Stacey L. Berg, MD     Texas Children's Cancer Center    
Study Chair:     Gregory H. Reaman, MD     Childrens Research Institute    
Information Provided By National Cancer Institute (NCI)
Verification Date October 2007
First Received Date  November 1, 1999
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




Links to all studies - primarily for crawlers