Clinical trial · Interventional
Carmustine in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme
A Phase I/II Study of the Safety and Tolerability of DTI-015 in Patients With Recurrent Glioblastoma Multiforme
NCT00006656CI-TRIAL-00012538unknownPhase 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. PURPOSE: Phase II trial to study the effectiveness of carmustine in treating patients who have progressive or recurrent 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carmustine in ethanol | Drug | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven supratentorial malignant glioblastoma multiforme * Clear evidence of disease progression by MRI * Unresectable tumor that has spherical, spheroid, or ovoid shape (not multicentric or multilobulated) * Central necrosis and/or central cystic areas allowed in the presence of enhancing rim thickness greater than 5 mm * No brainstem (pons or medulla) or midbrain (mesencephalon) involvement * No involvement of primary sensorimotor cortex in the dominant hemisphere or within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve * No tumor extension into the ventricular system * Tumor volume no greater than 33.4 cm3 * At least one prior radiotherapy PATIENT CHARACTERISTICS: Age: * 18 to 75 Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * No evidence of bleeding diathesis Hepatic: * Bilirubin no greater than 2.0 mg/dL * SGOT/SGPT no greater than 2.5 times normal Renal: * Creatinine no greater than 2.0 mg/dL OR * Creatinine clearance at least 40 mL/min * BUN no greater than 30 mg/dL Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active uncontrolled infection * Afebrile unless fever due to presence of tumor * No other concurrent serious medical or psychiatric illness that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin including Gliadel wafer therapy) and recovered Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered * No prior intracranial brachytherapy Surgery: * Recovered from any prior surgery Other: * No prior anticoagulants * No other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.