506U78 in Treating Patients With Refractory Hematologic Cancer - Full Text View

Sponsor:	Pediatric Oncology Group
Collaborators:	National Cancer Institute (NCI) Children's Cancer Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002970

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	Intervention	Phase
Leukemia Lymphoma	Drug: cytarabine Drug: methotrexate Drug: nelarabine Drug: therapeutic hydrocortisone	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase II Study of Compound 506U78 in Patients With Refractory T-Cell Malignancies - POG/CCG Intergroup Study

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	148
Study Start Date:	June 1997

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.

Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002970

Show 65 Study Locations

Sponsors and Collaborators

Pediatric Oncology Group

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	Children's Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000065478, POG-9673, CCG-P9673
Study First Received:	November 1, 1999
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00002970 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent childhood acute lymphoblastic leukemia
recurrent childhood lymphoblastic lymphoma
T-cell childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:

Antimetabolites
Anti-Inflammatory Agents
Anti-Infective Agents
Hydrocortisone
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Leukemia
Therapeutic Uses
Abortifacient Agents
Methotrexate
Dermatologic Agents

Lymphoma
Nucleic Acid Synthesis Inhibitors
Cytarabine
Immunoproliferative Disorders
Neoplasms by Histologic Type
Cortisol succinate
Immune System Diseases
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms

ClinicalTrials.gov processed this record on November 30, 2009