Clinical trial · Interventional
Carmustine in Treating Patients With Recurrent Malignant Glioma
PHASE I, OPEN LABEL, MULTICENTER DOSE ESCALATION STUDY OF GLIADEL IN PATIENTS WITH RECURRENT MALIGNANT GLIOMA
NCT00004028CI-TRIAL-00002003completedPhase 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. PURPOSE: Phase I trial to study the effectiveness of carmustine in treating patients who are undergoing surgery for recurrent 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 |
|---|---|---|---|
| carmustine | Drug | Carmustine | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Pathologically confirmed recurrent malignant glioma for which surgery is indicated * Unilateral, supratentorial, solitary lesion at least 1.0 cm in diameter on contrast-enhanced CT or MRI PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * At least 8 weeks Hematopoietic: * WBC at least 3,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin, AST, ALT, and alkaline phosphatase less than 2.5 times normal Renal: * Creatinine less than 1.5 times normal * BUN less than 2.5 times normal * Protein no greater than 3 g/dL * No gross hematuria Other: * No hypersensitivity to nitrosoureas * Not pregnant * Fertile patients must use effective contraception * No concurrent life threatening disease PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy during first 8 weeks of study Chemotherapy: * At least 4 weeks since chemotherapy (6 weeks since nitrosoureas) * No concurrent chemotherapy during first 8 weeks of study Endocrine therapy: * Not specified Radiotherapy: * Prior definitive external-beam radiotherapy (i.e., at least 5,000 cGy) required * No concurrent radiotherapy or brachytherapy during first 4 weeks of study Surgery: * Prior cytoreductive surgery for supratentorial brain tumor required * Biopsy alone not sufficient Other: * No concurrent investigational therapy during first 8 weeks of study
References
Publications (1)
- RESULTOlivi A, Grossman SA, Tatter S, Barker F, Judy K, Olsen J, Bruce J, Hilt D, Fisher J, Piantadosi S; New Approaches to Brain Tumor Therapy CNS Consortium. Dose escalation of carmustine in surgically implanted polymers in patients with recurrent malignant glioma: a New Approaches to Brain Tumor Therapy CNS Consortium trial. J Clin Oncol. 2003 May 1;21(9):1845-9. doi: 10.1200/JCO.2003.09.041. PMID 12721262