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Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Newly Diagnosed Malignant Glioma

NCT ID: NCT01656980

Last Updated: 2012-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Malignant gliomas recur mostly 2 cm within originated area. Local therapies therefore become particular important. Gliadel wafer developed in the States and marketed in the developed countries is an example of such treatments. The product in this study, Carmustine Sustained Release Implant (CASANT), is similar to that of Gliadel wafer as for the API(Active Pharmaceutical Ingredient), but different as for drug delivering system. As required, the preliminary clinical studies were conducted in China. Based on the results of phase I/II , 8-10 wafers containing given dose of BCNU will be administered intracranially in this phase III to the tumor resected cavity to investigate the safety and efficacy in the treatment of primary malignant glioma in 236 patients.

Conditions

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Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anaplastic Oligoastrocytoma Glioblastoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Carmustine Sustained Release Implant

For subjects in this group, they will accept intracranially implanted carmustine intraoperatively.

Group Type EXPERIMENTAL

Carmustine

Intervention Type DRUG

As Experimental group, subjects will accept specified wafers of carmustine in the cavity while gliomas maximally be resected.

Tumor Resection Surgery

For subjects in this control group, they accept no implants while gliomas maximally be resected.

Group Type SHAM_COMPARATOR

tumor resection surgery

Intervention Type PROCEDURE

For this group, subjects will accept routine tumor resection surgery and place no implant wafers.

Interventions

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Carmustine

As Experimental group, subjects will accept specified wafers of carmustine in the cavity while gliomas maximally be resected.

Intervention Type DRUG

tumor resection surgery

For this group, subjects will accept routine tumor resection surgery and place no implant wafers.

Intervention Type PROCEDURE

Other Intervention Names

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Trade name: CASANT Other name: BCNU blank control group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong Lanjin Pharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan H Sun, M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing Tiantan Hospital

Locations

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Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Yan H Sun, M.D.

Role: CONTACT

Phone: +86-1360-1389-945

Email: [email protected]

Jian J Yu, Master

Role: CONTACT

Phone: +86-15336402751

Email: [email protected]

Facility Contacts

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Yan H Sun, M.D.

Role: primary

Jian J Yu, Master

Role: backup

Related Links

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http://lanjin.cn

You will see subjects recruitment information when visiting above website.

Other Identifiers

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LJ-Glioma 3. 3.0 Version

Identifier Type: -

Identifier Source: org_study_id