Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Glioma

Astrocytoma

Oligodendroglioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Anaplastic Astrocytoma

Anaplastic Oligodendroglioma

Oligoastrocytoma

Anaplastic Oligoastrocytoma

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Carmustine

Antineoplastic Agents, Alkylating

Alkylating Agents

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

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

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

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

tumor resection surgery

Yan H Sun, M.D.

Jian J Yu, Master

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.

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.

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

Occurrence rate of adverse event and serious adverse event revealed by laboratory test outcomes including blood routine and chemistry as well as physical examination, vital signs including blood pressure, temperature, respiratory rate , heart rate.

Shandong Lanjin Pharmaceuticals Co.,Ltd

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Newly Diagnosed Malignant Glioma	NCT01656980	Anaplastic Astr... Anaplastic Olig... Anaplastic Olig... Glioblastoma	Carmustine tumor resection...	18 Years - 70 Years	Shandong Lanjin Pharmaceuticals Co.,Ltd
Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Newly Diagnosed Malignant Glioma	NCT01656980	Anaplastic Astr... Anaplastic Olig... Anaplastic Olig... Glioblastoma	Carmustine tumor resection...	18 Years - 70 Years	Shandong Lanjin Pharmaceuticals Co.,Ltd

Spots Global Cancer Trial Database for tumor resection surgery