Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

506U78 in Treating Patients With Refractory Hematologic Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	21 and below	NCI	POG-9673 CCG-P9673, NCT00002970, P9673

Objectives

1. 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.
2. Determine the toxicities of compound 506U78 in this group of patients.
3. Correlate the biochemical pharmacology of compound 506U78 (e.g., ara-G nucleotides in leukemic blasts and CSF concentrations) with clinical response.
4. Determine the impact of compound 506U78 therapy on survival and duration of response of patients with recurrent T-cell malignancies.

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

Pediatric Oncology Group

Stacey Berg, MD, Protocol chair		Ph: 832-824-4588

Children's Cancer Group

Gregory Reaman, MD, Protocol chair		Ph: 202-884-2147 Email: greaman@childrensoncologygroup.org

Registry Information
Official Title		A Phase II Study of Compound 506U78 in Patients With Refractory T-Cell Malignancies - POG/CCG Intergroup Study
Trial Start Date		1997-06-01
Registered in ClinicalTrials.gov		NCT00002970
Date Submitted to PDQ		1997-06-01
Information Last Verified		2007-10-31
NCI Grant/Contract Number		CA30969

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