NCT00019409

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Giving radiation therapy to the head or intrathecal chemotherapy may prevent cancer cells from spreading to the brain. It is not yet known which treatment regimen is more effective for acute lymphoblastic leukemia. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the head or intrathecal chemotherapy plus high dose cytarabine in preventing CNS disease in children who have acute lymphoblastic leukemia.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 1999

Shorter than P25 for phase_3 leukemia

Geographic Reach
2 countries

6 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2001

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
2.6 years until next milestone

First Posted

Study publicly available on registry

February 27, 2004

Completed
Last Updated

March 23, 2012

Status Verified

March 1, 2012

First QC Date

July 11, 2001

Last Update Submit

March 21, 2012

Conditions

Leukemia

Keywords

untreated childhood acute lymphoblastic leukemiachildhood acute lymphoblastic leukemia in remissionL1 childhood acute lymphoblastic leukemiaL2 childhood acute lymphoblastic leukemia

Interventions

asparaginaseDRUG
cyclophosphamideDRUG
cytarabineDRUG
daunorubicin hydrochlorideDRUG
mercaptopurineDRUG
methotrexateDRUG
prednisoneDRUG
therapeutic hydrocortisoneDRUG
vincristine sulfateDRUG
radiation therapyRADIATION

Eligibility Criteria

Age1 Year - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: Cytologically confirmed acute lymphoblastic leukemia Greater than 25% lymphoblasts in bone marrow No mediastinal or localized lymphoblastic lymphoma No single node or extranodal site without bone marrow involvement No B cell lymphoma (Burkitt's or L3 FAB) No blast cells positive for myeloperoxidase No CNS disease PATIENT CHARACTERISTICS: Age: 1-20 Performance status: Not specified Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Not specified Renal: Not specified Other: HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No prior corticosteroids Radiotherapy: No prior radiotherapy Surgery: Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

Pediatric Oncology Branch

Bethesda, Maryland, 20892, United States

Location

Texas Tech University Health Sciences Center School of Medicine

Amarillo, Texas, 79106, United States

Location

Kidwai Memorial Institute of Oncology

Bangalore, 560029, India

Location

Cancer Institute (W.I.A.)

Madras, 600020, India

Location

Tata Memorial Centre

Mumbai, 400012, India

Location

All-India Institute of Medical Sciences

New Delhi, 110029, India

Location

MeSH Terms

Conditions

LeukemiaPrecursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

AsparaginaseCyclophosphamideCytarabineDaunorubicinMercaptopurineMethotrexatePrednisoneHydrocortisoneVincristineRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

AmidohydrolasesHydrolasesEnzymesEnzymes and CoenzymesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesSulfhydryl CompoundsSulfur CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingAminopterinPterinsPteridinesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPregnenedionesPregnenes11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-HydroxycorticosteroidsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesIndolizidinesIndolizinesTherapeutics

Study Officials

  • Ian Trevor Magrath, MD, FRCP, FRCPath

    National Cancer Institute (NCI)

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

February 27, 2004

Study Start

October 1, 1999

Study Completion

July 1, 2001

Last Updated

March 23, 2012

Record last verified: 2012-03

Locations

US(2)IN(4)