Clinical trial · Interventional
Radiation Therapy and Chemotherapy in Treating Children With CNS Relapse From Acute Lymphoblastic Leukemia
TREATMENT OF ISOLATED CNS RELAPSE OF ACUTE LYMPHOBLASTIC LEUKEMIA -- A PEDIATRIC ONCOLOGY GROUP-WIDE PHASE II STUDY
NCT00002704CI-TRIAL-00009252completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (16)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| asparaginase | Drug | Asparaginase | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| daunorubicin hydrochloride | Drug | Daunorubicin | ALIAS |
| dexamethasone | Drug | Dexamethasone | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| liposomal cytarabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Single Agent Chemotherapy. TSPA or DTC101. 3-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. DM/DNR/VCR; plus TIT. 2-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. ARA-C/ASP; plus TIT. 4-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple Intrathecal Therapy. CTX/MP/MTX/VP-16; with CF; plus TIT. 3-Drug Combination Chemotherapy plus Triple Intrathecal Therapy. DM/DNR/VCR; plus TIT. 6-Drug Combination Chemotherapy with Leucovorin Rescue plus Triple Intrathecal Therapy. ARA-C/ASP/CTX/MP/MTX/VP-16; with CF; plus TIT. Radiotherapy plus 3-Drug Combination Chemotherapy. Craniospinal irradiation using x-rays with energies of 4-6 MV (electrons acceptable for spinal cord irradiation); plus ASP/DM/VCR. 2-Drug Combination Chemotherapy Alternating with 2-Drug Combination Chemotherapy. MP/MTX; alternating with CTX/VCR.
- interventionNames
- Biological: filgrastim
- Drug: asparaginase
- Drug: cyclophosphamide
- Drug: daunorubicin hydrochloride
- Drug: dexamethasone
- Drug: etoposide
- Drug: leucovorin calcium
- Drug: liposomal cytarabine
- Drug: mercaptopurine
- Drug: mesna
- Drug: methotrexate
- Drug: therapeutic hydrocortisone
- Drug: thiotepa
- Drug: vincristine sulfate
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 20 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDEapen M, Zhang MJ, Devidas M, Raetz E, Barredo JC, Ritchey AK, Godder K, Grupp S, Lewis VA, Malloy K, Carroll WL, Davies SM, Camitta BM; Children's Oncology Group; Center for International Blood and Marrow Transplant Research. Outcomes after HLA-matched sibling transplantation or chemotherapy in children with acute lymphoblastic leukemia in a second remission after an isolated central nervous system relapse: a collaborative study of the Children's Oncology Group and the Center for International Blood and Marrow Transplant Research. Leukemia. 2008 Feb;22(2):281-6. doi: 10.1038/sj.leu.2405037. Epub 2007 Nov 22. PMID 18033318
- RESULTBarredo JC, Devidas M, Lauer SJ, Billett A, Marymont M, Pullen J, Camitta B, Winick N, Carroll W, Ritchey AK. Isolated CNS relapse of acute lymphoblastic leukemia treated with intensive systemic chemotherapy and delayed CNS radiation: a pediatric oncology group study. J Clin Oncol. 2006 Jul 1;24(19):3142-9. doi: 10.1200/JCO.2005.03.3373. PMID 16809737