drugset / Trial / NCT00019409
Radiation Therapy to the Head or Intrathecal Chemotherapy Plus High Dose Cytarabine in Preventing CNS Disease in Children With Acute Lymphoblastic Leukemia
Phase 3
Withdrawn
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI) · collab
RandomizedTreatment
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.
Timeline
- Start
- 1999-10
- Primary completion
- —
- Completion
- 2001-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | — | Intravenous |
| Subject | Hydrocortisone | Other / unclassified | — | Intrathecal |
| Subject | Methotrexate | Small molecule | — | Oral |
| Background | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Background | Daunorubicin | Small molecule | — | Intravenous |
| Background | MERCAPTOPURINE ANHYDROUS | Small molecule | — | Oral |
| Background | Prednisone | Other / unclassified | — | Oral |
| Background | Vincristine | Small molecule | — | Intravenous |
| Background | asparaginase | Protein / enzyme biologic | — | Intramuscular |