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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01656980
Recruitment Status : Unknown
Verified August 2012 by Shandong Lanjin Pharmaceuticals Co.,Ltd.
Recruitment status was:  Not yet recruiting
First Posted : August 3, 2012
Last Update Posted : August 3, 2012
Sponsor:
Information provided by (Responsible Party):
Shandong Lanjin Pharmaceuticals Co.,Ltd

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anaplastic Oligoastrocytoma Glioblastoma Drug: Carmustine Procedure: tumor resection surgery Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 236 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Newly Diagnosed Malignant Glioma
Study Start Date : August 2012
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Carmustine

Arms and Interventions
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Arm Intervention/treatment
Experimental: Carmustine Sustained Release Implant
For subjects in this group, they will accept intracranially implanted carmustine intraoperatively.
 Drug: Carmustine
As Experimental group, subjects will accept specified wafers of carmustine in the cavity while gliomas maximally be resected.
Other Names:
  • Trade name: CASANT
  • Other name: BCNU
Sham Comparator: Tumor Resection Surgery
For subjects in this control group, they accept no implants while gliomas maximally be resected.
 Procedure: tumor resection surgery
For this group, subjects will accept routine tumor resection surgery and place no implant wafers.
Other Name: blank control group


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 15 months ]

Secondary Outcome Measures :
  1. Progress Free Survival [ Time Frame: 15 months ]
  2. Overall Survival Rate at 12 months [ Time Frame: 15 months ]
  3. Karnofsky Performance Status(KPS) [ Time Frame: 15 months ]
  4. Quality of Life(QOL) [ Time Frame: 15 months ]
  5. Safety of intracranially implanted carmustine after maximal tumor resection [ Time Frame: 15 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656980


Contacts
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Contact: Yan H Sun, M.D. +86-1360-1389-945 sunyanhui1109@yahoo.com.cn
Contact: Jian J Yu, Master +86-15336402751 yujj@lanjin.cn

Locations
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China, Beijing
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing, China, 100050
Contact: Yan H Sun, M.D.    +86-1360-1389-945    sunyanhui1109@yahoo.com.cn   
Contact: Jian J Yu, Master    +86-15336402751    Yujj@lanjin.cn   
Sponsors and Collaborators
Shandong Lanjin Pharmaceuticals Co.,Ltd
Investigators
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Principal Investigator: Yan H Sun, M.D. Beijing Tiantan Hospital
More Information
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Additional Information:
You will see subjects recruitment information when visiting above website.  This link exits the ClinicalTrials.gov site

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Responsible Party: Shandong Lanjin Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT01656980    
Other Study ID Numbers: LJ-Glioma 3. 3.0 Version
First Posted: August 3, 2012    Key Record Dates
Last Update Posted: August 3, 2012
Last Verified: August 2012
Additional relevant MeSH terms:
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Glioblastoma
Glioma
Astrocytoma
Oligodendroglioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Carmustine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents