Clinical trial · Interventional
Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Recurrent Malignant Glioma
Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Recurrent Malignant Glioma
NCT01637753CI-TRIAL-00007378unknownN/AClinicalTrials.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)
The purpose of the study is to determine the safety and efficacy of intracranially implanted Carmustine in the treatment of patients with recurrent malignant glioma.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Astrocytoma | Anaplastic Astrocytoma | CURATED_BROADER | 0.80 |
| Anaplastic Oligoastrocytoma | Anaplastic Oligoastrocytoma | CURATED_BROADER | 0.80 |
| Anaplastic Oligodendroglioma | Anaplastic Oligodendroglioma | CURATED_BROADER | 0.80 |
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carmustine(BCNU) | Drug | Carmustine | ALIAS |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Carmustine Sustained Release Implant
- interventionNames
- Drug: Carmustine(BCNU)
- type
- SHAM_COMPARATOR
- label
- Surgical control group
- interventionNames
- Procedure: Surgery
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 12 months
Secondary outcomes (6)
- measure
- Overall Survival Rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be 18 to 70 years old, signed ICF; * At least 4 weeks after previous chemotherapy (6 weeks since nitrosoureas); * KPS ≥ 60; * Unilateral, Supratentorial, solitary lesion and not crossing the midline(exclude patients with little tumors near the resectable tumor even if investigators think they are single lesions) * No obvious important organ dysfunction: Blood routine: White blood cell (WBC) ≥ 4.0×109/L, Absolute neutrophil count (ANC)≥ 1.5×109/L, Platelets≥ 100×109/L, Hemoglobin≥ 90 g/L; Hepatic function:Serum total bilirubin ≤1.5 times upper limit of laboratory normal; Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT)\<2.5 times upper limit of laboratory normal; Renal function:Serum creatinine ≤1.5 times upper limit of laboratory normal; * Not Pregnant or lactating for women of childbearing potential. Exclusion Criteria: * Tumor located at ventricular system, Open ventricle tumor cavity postoperatively; * Concomitant with other life-threatening diseases and with life expectancy \<3 months; * Allergic to nitrosourea drugs; * With history of intracranial radiotherapy or implant chemotherapy; * With serious cardiac, pulmonary, hepatic and renal dysfunction, poor glycemic control; * Investigators thought unsuitable for enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.