Clinical trial · Interventional
Carboplatin Plus Irinotecan in Treating Patients With Glioblastoma Multiforme
A Phase I/II Trial of CPT-11 With Carboplatin in Patients With Glioblastoma Multiforme Prior to Radiation Therapy
NCT00010036CI-TRIAL-00004622completedPhase 2ClinicalTrials.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 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: Phase II trial to study the effectiveness of combining carboplatin with irinotecan in treating patients who have glioblastoma multiforme.
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 |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme * Measurable disease * No CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 OR * Karnofsky 70-100% Life expectancy: * At least 12 weeks Hematopoietic: * Granulocyte count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin at least 9.0 g/dL Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver involvement) * No known Gilbert's syndrome Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * No myocardial infarction within the past 6 months * No congestive heart failure requiring therapy Other: * HIV negative * No active or uncontrolled infection * No psychiatric disorder that would preclude study * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix * No uncontrolled diabetes mellitus (i.e., random blood sugar of 200 mg or more) * No other severe disease that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior immunotherapy or biologic therapy * No concurrent sargramostim (GM-CSF) * No concurrent filgrastim (G-CSF) with course 1 * No concurrent immunotherapy Chemotherapy: * No prior chemotherapy * No other concurrent chemotherapy Endocrine therapy: * Must have maintained a stable or decreasing dose of corticosteroids for 2 weeks prior to study * Concurrent corticosteroids for cerebral edema allowed * No concurrent anticancer hormonal therapy Radiotherapy: * No prior radiotherapy * No concurrent radiotherapy Surgery: * At least 2 weeks since prior surgery Other: * No other concurrent investigational agent or participation on any other clinical study * No concurrent immunosuppressive drugs * No concurrent phenobarbital or valproic acid * No concurrent anticonvulsants except carbamazepine or gabapentin * No concurrent prochlorperazine on day of irinotecan treatment
References
Publications (0)
Data not yet available
No reference posted for this study.