Radiation Therapy and Chemotherapy in Treating Children With CNS Relapse From Acute Lymphoblastic Leukemia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Phase II trial to study the effectiveness of radiation therapy following chemotherapy in treating children with CNS relapse from acute lymphoblastic leukemia. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more cancer cells.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: 6-Mercaptopurine; Asparaginase; Cortisol succinate; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Etoposide; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Leucovorin; Levoleucovorin; Mercaptopurine; Methotrexate; Thiotepa; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Acute lymphoblastic leukemia in first bone marrow remission (M1) with first isolated initial CNS relapse

• More than 5 WBC/microliter in cerebrospinal fluid (CSF) with blasts on cytospin OR immunophenotypic proof (encouraged) of relapse in CSF

• Identifiable blasts and presence on 2 CSF samples 3 weeks apart

• If B-cell terminal deoxynucleotidyl transferase (TdT) OR CD-10

• If T-cell TdT alone OR with CD-7

PATIENT CHARACTERISTICS:

• Age: Over 6 months and under 21 years at relapse

• Patients receiving sustained release cytarabine

• Performance status: Older than 10 years

• Karnofsky greater than 50% Less than 10 years

• Lansky greater than 50%

• Platelet count greater than 40,000/mm3

• Bilirubin less than 2.0 mg/dL

• SGPT less than 5 times normal

• Creatinine less than 1.5 times normal for age

• Normal metabolic parameters (serum electrolytes, calcium, and phosphorus)

• No clinical evidence of obstructive hydrocephalus, compartmentalization of the CSF flow, ventriculoperitoneal or ventriculoatrial shunt

PRIOR CONCURRENT THERAPY:

• Prior cumulative anthracycline dose less than 375 mg/sqm

• Patients receiving sustained release cytarabine

• At least 7 days since prior investigational drug

• At least 3 weeks since prior CNS directed therapy (6 weeks is prior nitrosourea)

• At least 1 week since intrathecal chemotherapy

• At least 8 weeks since prior craniospinal radiotherapy