Clinical trial · Interventional
SarCNU in Treating Patients With Recurrent Malignant Glioma
A Phase II Study of SarCNU (NSC 364432) in Patients With Malignant Glioma
NCT00036660CI-TRIAL-00044503completedPhase 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 sarCNU in treating patients who have 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SarCNU | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignant glioma * Anaplastic astrocytoma (AA) OR * Glioblastoma multiforme (GBM) * Recurrent or progressive disease by contrast-enhanced CT scan or MRI after primary surgery and radiotherapy * At least 1 bidimensionally measurable lesion * At least 1 cm by 1 cm on contrast-enhanced CT scan or MRI PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute granulocyte count at least 1,500/mm3 * Platelet count at least 120,000/mm3 Hepatic: * Bilirubin normal * AST and ALT no greater than 2.5 times upper limit of normal Renal: * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Pulmonary: * DLCO at least 70% of predicted * FVC at least 70% of predicted Other: * No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix * No ongoing or active uncontrolled infection * No other serious illness or medical condition that would preclude study * No history of significant neurologic or psychiatric disorder that would preclude study * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 6 weeks since prior immunotherapy * No concurrent immunotherapy Chemotherapy: * At least 6 weeks since prior chemotherapy * No more than 1 prior adjuvant chemotherapy regimen for AA * No prior chemotherapy for recurrent disease * No other concurrent chemotherapy Endocrine therapy: * Patients must be on a stable dose of steroids for at least 2 weeks prior to study Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy * No prior radiotherapy for recurrent disease * No concurrent radiotherapy Surgery: * See Disease Characteristics * Prior surgery for recurrent disease (e.g., stereotactic biopsy or partial resection) allowed * At least 4 weeks since prior surgery (except for biopsy) Other: * At least 6 weeks since prior investigational agents * No other concurrent investigational agents * No other concurrent anticancer treatment
References
Publications (1)
- RESULTWebster M, Cairncross G, Gertler S, Perry J, Wainman N, Eisenhauer E. Phase II trial of SarCNU in malignant glioma: unexpected pulmonary toxicity with a novel nitrosourea: a phase II trial of the national cancer institute of canada clinical trials group. Invest New Drugs. 2005 Dec;23(6):591-6. doi: 10.1007/s10637-005-1761-3. PMID 16034522