Clinical trial · Interventional
Combination Chemotherapy in Treating Children With Progressive Brain Tumors
Chemotherapy for Progressive Low Grade Astrocytoma in Children Less Than Ten Years Old
- 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. Combining more than one drug may kill more tumor cells. PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens and comparing how well they work in treating children with low-grade astrocytomas or other residual tumors of the brain.
Conditions
Conditions (2)
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 Tumors | Brain Neoplasm | ALIAS | 0.90 |
| Central Nervous System Tumors | Central Nervous System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| lomustine | Drug | Lomustine | ALIAS |
| procarbazine hydrochloride | Drug | Procarbazine | ALIAS |
| thioguanine | Drug | Thioguanine | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Regimen A (CV Chemotherapy)
- description
- Induction will consist of 10 weeks of therapy (carboplatin, vincristine sulfate),followed by 2 weeks without chemotherapy. Induction should only be interrupted in the event of grade 3 neurotoxicity, grade 2 renal toxicity, grade 4 hematologic toxicity, or tumor progression. Maintenance-Four Courses (2 cycles/course) commences on Day 84 (week 12) of Induction or when peripheral counts recover with ANC \>1,000/$L and platelet count \>100,000/$L. Each cycle will consist of 4 weekly doses of carboplatin, three weekly doses of vincristine sulfate (given concomitantly with the first 3 weeks of carboplatin), followed by two weeks of rest for a total of 6 weeks. Maintenance will continue for a total of 8 cycles.
- interventionNames
- Drug: carboplatin
- Drug: vincristine sulfate
- type
- EXPERIMENTAL
- label
- Regimen B (TPCV Chemotherapy)
- description
- Each cycle of chemotherapy consists of 4 days of oral chemotherapy (Thioguanine, procarbazine hydrochloride, Lomustine and Vincristine sulfate beginning Day 0, followed by vincristine sulfate IV on Days 14 and 28. The cycle is repeated every 6 weeks (42 days). A total of 8 cycles will be given.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 9 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Pathologically confirmed low grade residual astrocytomas or other eligible residual tumors of the brain interpreted as low grade (WHO grades I and II) such as the following:
* Glial Tumors
* Astrocytic tumors
* Low grade astrocytoma (variants: fibrillary, protoplasmic, gemistocytic)
* Pilocytic astrocytoma
* Pleomorphic xanthoastrocytomas
* Subependymal giant cell astrocytoma
* Infantile desmoplastic astrocytoma
* Low grade oligodendroglial tumors
* Low grade oligodendroglioma
* Low grade mixed gliomas
* Oligo-astrocytoma
* Neuronal Tumors
* Ganglioglioma (excluding tumors with anaplastic astrocytic components)
* Infantile desmoplastic ganglioglioma
* Chiasmatic-hypothalamic tumor without histologic confirmation
* All of the following diagnostic tests (radiological or clinical evidence of progression, surgery, or confirmatory MRI) must be carried out within 6 weeks of enrollment into this study
* Progressive disease following surgical excision based on clear radiological or clinical evidence of progression, or an incomplete excision (less than 95% or greater than 1.5 cm2) with necessity to begin treatment because of a risk of neurologic impairment with progression
* Chiasmatic lesions that have contiguous extensions of tumor into other regions of the visual pathways demonstrated on contrast MRI will be eligible for study without histopathological confirmation
* Patients with neurofibromatosis who have radiographic diagnosis of chiasmatic-hypothalamic tumor are eligible for the study, without requiring a biopsy confirmation of tumor histology, but not unless tumor progression is documented radiographically
* No intrinsic brain stem tumors of the pons or isolated optic nerve tumors without definitive involvement of the optic chiasm
PATIENT CHARACTERISTICS:
Age:
* Under 10
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count greater than 1,000/mm\^3 (arm II)
* Platelet count greater than 100,000/mm\^3 (arm II)
Hepatic:
* Not specified
Renal:
* Creatinine less than 1.5 times upper limit of normal for age OR
* Creatinine clearance or radioisotope GFR greater than 70 mL/min or equivalent GFR as determined by the institutional normal range
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy for the tumor
Endocrine therapy:
* Prior corticosteroid therapy allowed
Radiotherapy:
* No prior radiotherapy for the tumor
Surgery:
* See Disease characteristics
Other:
* Prior diuretic therapy allowedReferences
Publications (1)
- RESULTAter JL, Zhou T, Holmes E, Mazewski CM, Booth TN, Freyer DR, Lazarus KH, Packer RJ, Prados M, Sposto R, Vezina G, Wisoff JH, Pollack IF. Randomized study of two chemotherapy regimens for treatment of low-grade glioma in young children: a report from the Children's Oncology Group. J Clin Oncol. 2012 Jul 20;30(21):2641-7. doi: 10.1200/JCO.2011.36.6054. Epub 2012 Jun 4. PMID 22665535