Clinical trial · Interventional
Carboplatin, Vincristine, and Temozolomide in Treating Children With Progressive and/or Symptomatic Low-Grade Glioma
A Pilot Study Using Carboplatin, Vincristine And Temozolomide For Children ≤ 10 Years With Progressive/Symptomatic Low-Grade Gliomas
NCT00077207CI-TRIAL-00032940completedN/AResults 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, such as carboplatin, vincristine, and temozolomide, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells. PURPOSE: This pilot study is studying giving carboplatin and vincristine together with temozolomide in treating children with progressive and/or symptomatic low-grade glioma.
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 Tumor | Brain Neoplasm | ALIAS | 0.90 |
| Central Nervous System Tumor | Central Nervous System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| temozolomide | Drug | Temozolomide | ALIAS |
| vincristine sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (carboplatin, vincristine sulfate, temozolomide)
- description
- Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.
- interventionNames
- Drug: carboplatin
- Drug: temozolomide
- Drug: vincristine sulfate
Primary outcomes (2)
- measure
- Short Term Feasibility Success
- timeFrame
- 24 weeks
- description
- Success is defined as the completion of induction plus one cycle of maintenance within 24 weeks of enrollment without more than a 25% reduction in either carboplatin or temozolomide dosage. Failure to complete the induction and one cycle of maintenance within 24 weeks counts as a short-term-feasibility failure.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 10 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed progressive and/or symptomatic low-grade glioma, including any of the following: * WHO grade I or II astrocytoma * Grade I or II oligodendrogliomas * Mixed oligodendrogliomas * Gangliogliomas * Measurable disease * Progressive and/or symptomatic supratentorial or spinal cord tumors that cannot be removed for anatomical reasons are allowed * Optic pathway tumors allowed provided there is evidence of progressive disease by MRI and/or symptoms of deteriorating vision, progressive hypothalamic/pituitary dysfunction, or diencephalic syndrome * Dorsally exophytic brainstem gliomas that were previously resected more than 50% are allowed provided the residual tumor shows progression (with or without symptoms) * No diffuse brain stem tumors * No type 1 neurofibromatosis PATIENT CHARACTERISTICS: Age * 10 and under Performance status * ECOG 0-2 * Lansky 50-100% Life expectancy * Not specified Hematopoietic * Hemoglobin ≥ 8.0 gm/dL * Absolute neutrophil count ≥ 1,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * ALT \< 2.5 times ULN Renal * Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR * Creatinine ≤ 0.8 mg/dL (age 5 and under) OR ≤ 1.0 mg/dL (age 6 to10) Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 2 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunomodulating agents Chemotherapy * No other concurrent anticancer chemotherapy Endocrine therapy * Prior corticosteroids allowed * No concurrent corticosteroids except for the treatment of increased intracranial pressure Radiotherapy * Not specified Surgery * See Disease Characteristics * Prior surgery allowed Other * No other prior therapy
References
Publications (1)
- RESULTChintagumpala M, Eckel SP, Krailo M, Morris M, Adesina A, Packer R, Lau C, Gajjar A. A pilot study using carboplatin, vincristine, and temozolomide in children with progressive/symptomatic low-grade glioma: a Children's Oncology Group studydagger. Neuro Oncol. 2015 Aug;17(8):1132-8. doi: 10.1093/neuonc/nov057. Epub 2015 Apr 7. PMID 25854526