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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 70 Years
Gender	All

More Inclusion & Exclusion Criteria

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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01656980
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Shandong Lanjin Pharmaceuticals Co.,Ltd
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yan H Sun, M.D.
Principal Investigator Affiliation	Beijing Tiantan Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Unknown status
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma, Glioblastoma
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

Experimental: Carmustine Sustained Release Implant

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

Sham Comparator: Tumor Resection Surgery

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

Interventions

Drug: - Carmustine

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

Procedure: - tumor resection surgery

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Beijing, Beijing, China

Status

Address

Beijing Tiantan Hospital Affiliated to Capital Medical University

Beijing, Beijing, 100050

Site Contact

Yan H Sun, M.D.

[email protected]

+86-1360-1389-945

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