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506U78 in Treating Patients With Refractory Hematologic Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Pediatric Oncology Group
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

MedlinePlus related topics:   Cancer    Leukemia, Adult Acute    Leukemia, Adult Chronic    Leukemia, Childhood    Lymphoma   

Drug Information available for:   Cytarabine    Cytarabine hydrochloride    Hydrocortisone    Cortisol 21-phosphate    Cortisol succinate    Hydrocortamate    Hydrocortisone 21-sodium succinate    Hydrocortisone acetate    Hydrocortisone cypionate    Hydrocortisone hemisuccinate    Proctofoam-HC    Methotrexate    Nelarabine   

U.S. FDA Resources

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

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  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     Childrens Research Institute    
  More Information


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

Study ID Numbers:   CDR0000065478, POG-9673, CCG-P9673
First Received:   November 1, 1999
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00002970
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  

Study placed in the following topic categories:
Leukemia, Lymphoid
Hydrocortisone
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Hematologic Neoplasms
Cortisol succinate
Lymphoblastic lymphoma
Recurrence
Folic Acid
Leukemia
Lymphatic Diseases
Methotrexate
Hydrocortisone acetate
Lymphoproliferative Disorders
Lymphoma
Cytarabine

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Reproductive Control Agents
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Therapeutic Uses
Abortifacient Agents
Antirheumatic Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 20, 2008




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