Clinical trial · Interventional
Carmustine Implants in Treating Patients With Brain Metastases
The Treatment of One or Two Supratentorial Brain Metastases With Surgical Resection and BCNU-Polymer Wafers
NCT00003878CI-TRIAL-00010911completedPhase 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. Giving the drugs in different ways may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of implanted carmustine wafers in treating patients who have brain metastases and who are undergoing surgery to remove the tumor.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| polifeprosan 20 with carmustine implant | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Supratentorial brain metastases for which surgery is recommended * Solitary, unilateral, intracranial mass consistent with metastasis on MRI scan OR * Two brain lesions consistent with metastases on MRI scan * Lesions must be accessible through a single craniotomy * Metastatic lesions clearly distinct from tumor bed of any benign lesions * Intraoperative frozen section diagnosis of metastatic tumor from CNS lesion * No prior malignant intracranial neoplasm * No lesion(s) in the brainstem * No open communication of the resection cavity with the ventricle following resection PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 60-100% Life expectancy * At least 3 months Hematopoietic * No concurrent hematologic disorders Hepatic * No concurrent hepatic disease Renal * No concurrent renal disease Cardiovascular * No concurrent cardiac disease Pulmonary * No concurrent pulmonary disorders Other * Not pregnant or nursing * Fertile patients must use effective contraception * Mini mental score at least 15 * No known hypersensitivity to carmustine or Gliadel wafers * No other serious concurrent medical illness or infection PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * No prior cranial irradiation Surgery * See Disease Characteristics * No prior surgery involving brain metastases or primary brain tumor(s) (except for benign intracranial lesions such as pituitary adenoma, meningioma, or schwannoma) Other * Concurrent systemic therapy allowed
References
Publications (0)
Data not yet available
No reference posted for this study.