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

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Locations

United States, Alabama
MBCCOP - Gulf Coast
Mobile, Alabama, United States, 36688
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94304
University of California Davis Medical Center
Sacramento, California, United States, 95817
University of California San Diego Cancer Center
La Jolla, California, United States, 92093-0658
United States, Connecticut
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States, 06520-8028
United States, District of Columbia
Walter Reed Army Medical Center
Washington, District of Columbia, United States, 20307-5000
United States, Florida
CCOP - Florida Pediatric
Tampa, Florida, United States, 33682-7757
Miami Children's Hospital
Miami, Florida, United States, 33155
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, United States, 32610-100277
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Emory University Hospital - Atlanta
Atlanta, Georgia, United States, 30322
United States, Hawaii
Cancer Research Center of Hawaii
Honolulu, Hawaii, United States, 96813
United States, Illinois
Children's Memorial Hospital, Chicago
Chicago, Illinois, United States, 60614
United States, Kansas
CCOP - Wichita
Wichita, Kansas, United States, 67214-3882
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160-7357
United States, Louisiana
CCOP - Ochsner
New Orleans, Louisiana, United States, 70121
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Ochsner Clinic
New Orleans, Louisiana, United States, 70121
United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Boston Floating Hospital Infants and Children
Boston, Massachusetts, United States, 02111
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01655
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216-4505
United States, Missouri
Cardinal Glennon Children's Hospital
Saint Louis, Missouri, United States, 63104
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Saint Peter's University Hospital
New Brunswick, New Jersey, United States, 08901-1780
Tomorrows Children's Institute
Hackensack, New Jersey, United States, 07601
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Schneider Children's Hospital
New Hyde Park, New York, United States, 11042
State University of New York - Upstate Medical University
Syracuse, New York, United States, 13210
University of Rochester Cancer Center
Rochester, New York, United States, 14642
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
East Carolina University School of Medicine
Greenville, North Carolina, United States, 27858-4354
Mission Saint Joseph's Health System
Asheville, North Carolina, United States, 28801
Presbyterian Healthcare
Charlotte, North Carolina, United States, 28233-3549
United States, Oklahoma
Oklahoma Memorial Hospital
Oklahoma City, Oklahoma, United States, 73126-0307
United States, Oregon
CCOP - Columbia River Program
Portland, Oregon, United States, 97213
United States, Pennsylvania
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134-1095
United States, South Carolina
Children's Hospital of Greenville Hospital System
Greenville, South Carolina, United States, 29605
Medical University of South Carolina
Charleston, South Carolina, United States, 29425-0721
United States, Tennessee
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105-2794
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
MBCCOP - South Texas Pediatric
San Antonio, Texas, United States, 78229-3900
Simmons Cancer Center - Dallas
Dallas, Texas, United States, 75235-9154
Texas Children's Cancer Center
Houston, Texas, United States, 77030-2399
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78284-7811
United States, Virginia
Cancer Center at the University of Virginia
Charlottesville, Virginia, United States, 22908
Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States, 23708-2197
United States, Wisconsin
Midwest Children's Cancer Center
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Ontario
Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Hopital Sainte Justine
Montreal, Quebec, Canada, H3T 1C5
McGill University Health Center - Montreal Children's Hospital
Montreal, Quebec, Canada, H3H 1P3
Switzerland
Swiss Pediatric Oncology Group Bern
Bern, Switzerland, CH 3010

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 27, 2009