Clinical trial · Interventional
Oxaliplatin in Treating Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumor, or Atypical Teratoid Rhabdoid Tumor
A Phase II Study of Oxaliplatin in Children With Recurrent or Refractory Medulloblastoma, Supratentorial Primitive Neuroectodermal Tumors and Atypical Teratoid Rhabdoid Tumors
NCT00047177CI-TRIAL-00002710completedPhase 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)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of oxaliplatin in treating children who have recurrent or refractory medulloblastoma, supratentorial primitive neuroectodermal or atypical teratoid rhabdoid tumor.
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 |
|---|---|---|---|
| Brain and Central Nervous System Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Objective response rate to oxaliplatin in recurrent or progressive medulloblastoma at first progression
- measure
- Objective response rate to oxaliplatin in recurrent or refractory medulloblastoma at second or later relapse
Secondary outcomes (2)
- measure
- Objective response rate to oxaliplatin in recurrent or progressive supratentorial PNETs or atypical teratoid rhabdoid tumor (ATRT)
- measure
- Pharmacokinetics of oxaliplatin in the serum and CSF
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed medulloblastoma, supratentorial primitive neuroectodermal tumor (including pineoblastomas and ependymoblastomas), or atypical teratoid rhabdoid tumor * Recurrent or refractory disease * Measurable disease by radiography * Patients with positive cerebrospinal fluid cytology or linear leptomeningeal disease are eligible PATIENT CHARACTERISTICS: Age * 21 and under Performance status * Karnofsky 50-100% OR * Lansky 50-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 100,000/mm\^3 (transfusion independent) * Hemoglobin at least 8.0 g/dL (RBC transfusions allowed) Hepatic * Bilirubin no greater than 1.5 times normal * ALT less than 2.5 times normal Renal * Creatinine no greater than 1.5 times normal OR * Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min Cardiovascular * Shortening fraction at least 27% by echocardiogram OR * Ejection fraction at least 50% by MUGA Pulmonary * No dyspnea at rest * No exercise intolerance * Pulse oximetry greater than 94% Other * No uncontrolled infection * No active graft-versus-host disease * No uncontrolled seizure disorders * Seizure disorders well controlled with anticonvulsants allowed * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * At least 2 weeks since prior growth factors * At least 6 months since prior allogeneic stem cell transplantation * No concurrent colony-stimulating factors during the first course of study * No concurrent immunomodulating agents Chemotherapy * At least 3 weeks since prior myelosuppressive therapy (6 weeks for nitrosoureas) and recovered * No other concurrent anticancer chemotherapy Endocrine therapy * If concurrent corticosteroids necessary for intracranial pressure, must be on stable or decreasing dose for at least 1 week prior to study * No other concurrent corticosteroids Radiotherapy * At least 2 weeks since prior local palliative radiotherapy (small port) to symptomatic metastatic sites * At least 3 months since prior craniospinal radiotherapy * No concurrent palliative radiotherapy * Recovered from prior radiotherapy Surgery * Not specified Other * No other concurrent anticancer or experimental drugs
References
Publications (1)
- RESULTFouladi M, Blaney SM, Poussaint TY, Freeman BB 3rd, McLendon R, Fuller C, Adesina AM, Hancock ML, Danks MK, Stewart C, Boyett JM, Gajjar A. Phase II study of oxaliplatin in children with recurrent or refractory medulloblastoma, supratentorial primitive neuroectodermal tumors, and atypical teratoid rhabdoid tumors: a pediatric brain tumor consortium study. Cancer. 2006 Nov 1;107(9):2291-7. doi: 10.1002/cncr.22241. PMID 17019740