Clinical trial · Interventional
Carboplatin, Temozolomide, and Filgrastim in Treating Patients With Newly Diagnosed or Recurrent High-Grade Glioma
Phase II Trial of Temozolomide, Carboplatin and Neupogen in High-Grade Gliomas, Both Newly-Diagnosed and Recurrent
- 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. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combining carboplatin, temozolomide, and filgrastim in treating patients who have newly diagnosed or recurrent high-grade 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| temozolomide | Drug | Temozolomide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 64 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed glioblastoma multiforme or anaplastic astrocytoma * Residual tumor on postoperative MRI * Bidimensionally measurable disease PATIENT CHARACTERISTICS: Age: * Under 65 Performance status: * Karnofsky or Lansky 70-100% OR * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,000/mm\^3 * Hemoglobin at least 8 g/dL (transfusion allowed) * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGPT no greater than 3 times ULN Renal: * Age 5 years and under: Creatinine less than 1.2 mg/dL * Age over 5 to 10 years: Creatinine less than 1.5 mg/dL * Age over 10 to 15 years: Creatinine less than 1.8 mg/dL * Age over 15 years: Creatinine less than 2.4 mg/dL Cardiovascular: * No myocardial infarction within the past 6 months Other: * No other concurrent serious medical condition that would preclude study * Able to tolerate oral medications * No prior malignancy for which patient received prior chemotherapy or spinal irradiation * No history of severe allergic reaction to platinum-containing compounds * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 72 hours since prior filgrastim (G-CSF) Chemotherapy: * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy: * Concurrent steroids for tumor-related cerebral edema allowed * No concurrent corticosteroids for solely antiemetic purposes Radiotherapy: * No prior or concurrent radiotherapy Surgery: * Recovered from prior surgery * No concurrent surgery
References
Publications (0)
Data not yet available