Clinical trial · Interventional
Carmustine Wafers Plus Irinotecan in Treating Patients With Recurrent Supratentorial High Grade Gliomas
Phase I Treatment of Adults With Recurrent Supratentorial High Grade Glioma With Gliadel Wafers Plus Irinotecan (CPT-11)
NCT00003463CI-TRIAL-00009484completedPhase 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 carmustine wafers plus irinotecan in treating patients with recurrent supratentorial high grade gliomas.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carmustine | Drug | Carmustine | ALIAS |
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| polifeprosan 20 with carmustine implant | Drug | — | UNRESOLVED |
| surgical procedure | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed recurrent supratentorial glioblastoma multiforme, anaplastic astrocytoma, or gliosarcoma * Must be able to undergo surgical resection * At least 1 bidimensionally measurable lesion documented on Gd-MRI within 72 hours after surgical implantation of Gliadel wafers * Not requiring immediate radiotherapy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 70-100% Life expectancy: * Greater than 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 125,000/mm\^3 * Hematocrit at least 29% Hepatic: * Bilirubin less than 1.5 times upper limit of normal (ULN) * SGOT or SGPT less than 2.5 times ULN * Alkaline phosphatase less than 2 times ULN Renal: * BUN less than 1.5 times ULN * Creatinine less than 1.5 times ULN Neurological: * Must be neurologically stable Other: * HIV negative * No AIDS-related illness * No nonmalignant systemic disease that would make patient a poor medical risk * No acute infection requiring intravenous antibiotics * Not pregnant or nursing * Negative pregnancy test 24 hours prior to study * Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior irinotecan * At least 6 weeks since chemotherapy unless there is unequivocal evidence of tumor progression after chemotherapy Endocrine therapy: * At least 1 week of nonincreasing dose of steroids prior to study Radiotherapy: * At least 6 weeks since radiotherapy unless there is unequivocal evidence of tumor progression after radiotherapy * No concurrent radiotherapy Surgery: * Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.