Clinical trial · Interventional
Irinotecan Followed by Radiation Therapy and Temozolomide in Treating Children With Newly Diagnosed Brain Tumor
Treatment of Newly Diagnosed High-Grade Gliomas in Patients Ages Greater Than or Equal to 3 and Less Than or Equal to 21 Years With a Phase II Irinotecan Window Followed by Radiation Therapy and Temozolomide
- 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. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of irinotecan followed by radiation therapy and temozolomide in treating children who have newly diagnosed brain 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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 21 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed newly diagnosed brain tumors
* Grade III or IV disease:
* Glioblastoma multiforme
* Anaplastic astrocytoma
* Anaplastic oligodendroglioma
* Anaplastic pleomorphic xanthoastrocytoma
* Anaplastic or malignant oligoastrocytoma
* Gemistocytic astrocytoma
* Malignant glioma
* Grade II glial tumors in unfavorable locations (i.e., imaging evidence of gliomatosis cerebri and/or bithalamic involvement)
* Diffuse pontine gliomas with greater than 2/3 involvement of the pon
PATIENT CHARACTERISTICS:
Age:
* 3 to 21
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* WBC greater than 2,500/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin greater than 8.0 g/dL
Hepatic:
* Bilirubin no greater than 2.5 mg/dL
* SGOT/SGPT less than 5 times normal
Renal:
* Creatinine no greater than 2.0 mg/dL
Other:
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* HIV negative
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* Prior corticosteroids allowed
Radiotherapy:
* No prior radiotherapy
Surgery:
* No more than 28 days since prior definitive surgery for brain tumor
Other:
* Concurrent anticonvulsants allowedReferences
Publications (3)
- RESULTBroniscer A, Chintagumpala M, Fouladi M, Krasin MJ, Kocak M, Bowers DC, Iacono LC, Merchant TE, Stewart CF, Houghton PJ, Kun LE, Ledet D, Gajjar A. Temozolomide after radiotherapy for newly diagnosed high-grade glioma and unfavorable low-grade glioma in children. J Neurooncol. 2006 Feb;76(3):313-9. doi: 10.1007/s11060-005-7409-5. PMID 16200343
- RESULTBroniscer A, Iacono L, Chintagumpala M, Fouladi M, Wallace D, Bowers DC, Stewart C, Krasin MJ, Gajjar A. Role of temozolomide after radiotherapy for newly diagnosed diffuse brainstem glioma in children: results of a multiinstitutional study (SJHG-98). Cancer. 2005 Jan 1;103(1):133-9. doi: 10.1002/cncr.20741. PMID 15565574
- RESULTBroniscer A, Chintagumpala M, Bowers D, et al.: Upfront protracted irinotecan (CPT-11) followed by radiotherapy (RT) and temozolomide (TMZ) in the treatment of children with newly diagnosed high-grade glioma (HGG) and unfavorable low-grade glioma (LGG): results of a multi-institutional study (SJHG-98). [Abstract] Neuro-Oncology 6 (4): TP-01, 385, 2004.