Clinical trial · Interventional
Chemotherapy Combined With Radiation Therapy for Newly Diagnosed CNS AT/RT
A Phase II Study of Intrathecal and Systemic Chemotherapy With Radiation Therapy for Children With Central Nervous System Atypical Teratoid/Rhabdoid Tumor (AT/RT) Tumor
NCT00084838CI-TRIAL-00020337completedPhase 2Results postedClinicalTrials.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)
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving more than one chemotherapy drug with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving intrathecal and systemic combination chemotherapy together with radiation therapy works in treating young patients with newly diagnosed central nervous system (CNS) atypical teratoid/rhabdoid tumors.
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 |
|---|---|---|---|
| Central Nervous System Tumor, Pediatric | Childhood Central Nervous System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (14)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| cytarabine | Drug | Cytarabine | ALIAS |
| Dactinomycin | Drug | Dactinomycin | ALIAS |
| dexrazoxane hydrochloride | Drug | — | UNRESOLVED |
| doxorubicin hydrochloride | Drug | Doxorubicin | ALIAS |
| etoposide | Drug | Etoposide | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Multi-agent Intrathecal and Systemic CT with RT (mod IRS III)
- description
- Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen \[vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)\] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT. Radiation Therapy: Pts w/ M0 dz OR M+ dz aged \<3y received focal RT (3D conformal or intensity-modulated delivery). Pts \>3y w/ M+ dz rcvd craniospinal irradiation. Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.
- interventionNames
- Biological: filgrastim
- Drug: cisplatin
- Drug: cyclophosphamide
- Drug: cytarabine
- Drug: dexrazoxane hydrochloride
- Drug: doxorubicin hydrochloride
- Drug: etoposide
- Drug: leucovorin calcium
- Drug: methotrexate
- Drug: temozolomide
- Drug: therapeutic hydrocortisone
- Drug: vincristine sulfate
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary intracranial Central Nervous System (CNS) atypical teratoid/rhabdoid tumor OR * Tumor tissue that possesses the INI-1 gene mutation * No metastases that disseminate outside the CNS by abdominal and chest computer tomography (CT) scans, kidney imaging, and bone marrow biopsy * No obstruction of cerebrospinal fluid (CSF) flow by CSF flow study * Definitive surgical resection of tumor within the past 35 days PATIENT CHARACTERISTICS: Age * 18 and under Performance status * Karnofsky 50-100% OR * Lansky 50-100% Life expectancy * Not specified Hematopoietic * Hemoglobin \> 10 g/dL * Absolute neutrophil count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 mg/dL * SGPT \< 10 times normal Renal * Creatinine ≤ 1.5 times normal Other * Willing to have placement of central venous access line PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Prior steroids allowed Radiotherapy * No prior radiotherapy Surgery * See Disease Characteristics Other * No other prior or concurrent investigational agents * Concurrent anticonvulsant agents allowed
References
Publications (1)
- RESULTChi SN, Zimmerman MA, Yao X, Cohen KJ, Burger P, Biegel JA, Rorke-Adams LB, Fisher MJ, Janss A, Mazewski C, Goldman S, Manley PE, Bowers DC, Bendel A, Rubin J, Turner CD, Marcus KJ, Goumnerova L, Ullrich NJ, Kieran MW. Intensive multimodality treatment for children with newly diagnosed CNS atypical teratoid rhabdoid tumor. J Clin Oncol. 2009 Jan 20;27(3):385-9. doi: 10.1200/JCO.2008.18.7724. Epub 2008 Dec 8. PMID 19064966