Clinical trial · Interventional
Cisplatin and Temozolomide in Treating Young Patients With Malignant Glioma
Phase II Study of the Combination of Cisplatin + Temozolomide in Malignant Glial Tumours in Children and Adolescents at Diagnosis or in Relapse
- 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 cisplatin and temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving cisplatin together with temozolomide works in treating young patients with malignant glioma.
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 (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| fluorescence in situ hybridization | Genetic | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| loss of heterozygosity analysis | Genetic | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Response rate after 2 courses
Secondary outcomes (4)
- measure
- Relapse-free survival
- measure
- Best response in patients receiving more than 2 courses
- measure
- Rate of progression at 6 months and 1 and 2 years
- measure
- Overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 20 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed diagnosis of 1 of the following grade III or grade IV malignant glial tumors\*:
* Glioblastoma
* Anaplastic astrocytoma
* Anaplastic oligodendroglioma
* Anaplastic oligoastrocytoma
* Anaplastic ganglioglioma
* Anaplastic mixed tumor
* Glial component is essential NOTE: \*Malignant gliomas occurring as a second primary malignancy allowed
* Newly diagnosed or recurrent disease
* No malignant brain stem tumors
* Incompletely resected tumors
* No completely resected tumors
* Measurable or evaluable disease by conventional MRI
PATIENT CHARACTERISTICS:
* Lansky performance status 40-100%
* Organ toxicity ≤ grade 2
* Absolute neutrophil count ≥ 1,000/mm³
* Platelet count ≥ 100,000/mm³
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* AST and ALT ≤ 2.5 times ULN
* Prothrombin ≥ 50%
* Fibrinogen ≥ 1.5 g/L
* Creatinine normal for age
* Creatinine ≤ 65 µmol/L (4-15 years of age)
* Creatinine ≤ 110 µmol/L (15-20 years of age)
* Audiogram with toxicity grade ≤ 2
* ECG normal
* Negative pregnancy test
* Fertile patients must use effective contraception
* No severe or life-threatening infection
* No uncontrolled developing or symptomatic intracranial hypertension
PRIOR CONCURRENT THERAPY:
* At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) or radiotherapy for patients with relapsed disease
* No prior cisplatin or temozolomide
* No other concurrent anticancer therapyReferences
Publications (0)
Data not yet available