Clinical trial · Interventional
Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma
Phase I Treatment of Adults With Primary Malignant Glioma With Irinotecan (CPT-11) (NSC- #6616348) Plus Temodar (NSC #362856)
NCT00005951CI-TRIAL-00015456completedPhase 1ClinicalTrials.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 I trial to study the effectiveness of irinotecan plus temozolomide in treating patients who have recurrent primary 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| temozolomide | Drug | Temozolomide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed recurrent primary malignant glioma * Anaplastic astrocytoma * Glioblastoma multiforme * Anaplastic oligodendroglioma * Gliosarcoma * Anaplastic mixed oligoastrocytoma * Measurable disease by MRI or CT * No immediate radiotherapy required * Neurologically stable for at least 2 weeks prior to study PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Greater than 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGOT and SGPT less than 2.5 times ULN * Alkaline phosphatase less than 2 times ULN Renal: * Blood urea nitrogen and creatinine less than 1.5 times ULN Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No other nonmalignant systemic disease * No acute infection treated with IV antibiotics * No frequent vomiting or other condition that would preclude oral medication administration (e.g., partial bowel obstruction) * No other prior malignancies except surgically cured carcinoma in situ of the cervix or basal or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: * No more than 1 prior biologic therapy regimen Chemotherapy: * No more than 1 prior chemotherapy regimen * At least 6 weeks since prior chemotherapy, unless evidence of disease progression * No prior failure of irinotecan or temozolomide Endocrine therapy: * Concurrent corticosteroids allowed Radiotherapy: * See Disease Characteristics * At least 6 weeks since prior radiotherapy, unless evidence of disease progression Surgery: * At least 3 weeks since prior surgery, unless evidence of disease progression, and recovered Other: * No concurrent immunosuppressive agents
References
Publications (0)
Data not yet available
No reference posted for this study.