Overview

Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With Acute Lymphoblastic Leukemia

Status:
Withdrawn

Trial end date:
2001-07-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

National Institutes of Health Clinical Center (CC)

Collaborator:

National Cancer Institute (NCI)

Treatments:

6-Mercaptopurine
Asparaginase
Cortisol succinate
Cyclophosphamide
Cytarabine
Daunorubicin
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Mercaptopurine
Methotrexate
Prednisone
Vincristine

Criteria

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