Clinical trial · Interventional
Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Newly Diagnosed Malignant Glioma
Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Newly Diagnosed Malignant Glioma
NCT01656980CI-TRIAL-00007733unknownPhase 3ClinicalTrials.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 primary 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 | Drug | Carmustine | ALIAS |
| tumor resection surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Carmustine Sustained Release Implant
- description
- For subjects in this group, they will accept intracranially implanted carmustine intraoperatively.
- interventionNames
- Drug: Carmustine
- type
- SHAM_COMPARATOR
- label
- Tumor Resection Surgery
- description
- For subjects in this control group, they accept no implants while gliomas maximally be resected.
- interventionNames
- Procedure: tumor resection surgery
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 15 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmation of high grade glioma(WHO III or above)by frozen or squash preparation; * 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 * No obvious important organ dysfunction: 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: * Underwent cytoreductive surgery(excluded stereotactic biopsy); * With chemotherapy or brain radiotherapy history; * Tumor located at ventricular system, Open ventricle tumor cavity postoperatively; * Concomitant with other life-threatening diseases and with life expectancy \<12 months; * Allergic to nitrosourea drugs; * With history of intracranial radiotherapy or implant chemotherapy; * With serious cardiac, pulmonary, hepatic and renal dysfunction, poor glycemic control; * Experienced \> 3 times of Large epilepsy within one month preoperatively. * Investigators thought unsuitable for enrollment.
References
Publications (0)
Data not yet available
No reference posted for this study.