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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Jun 30, 2004

Keywords

ClinConnect Summary

OBJECTIVES:

I. Determine the efficacy and toxicity of intensified systemic treatment with delayed central nervous system (CNS) irradiation in children with acute lymphoblastic leukemia and isolated CNS disease.

II. Determine the efficacy of systemic thiotepa in reducing or clearing blasts in the cerebrospinal fluid of these patients.

III. Evaluate the toxicity of single dose thiotepa followed by dexamethasone, vincristine, daunorubicin, and triple intrathecal therapy in these patients.

IV. Determine the response rate of intrathecal sustained release cytarabine (DTC101) in patients with ...

Gender

ALL

Eligibility 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