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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2012 by Shandong Lanjin Pharmaceuticals Co.,Ltd
Sponsor:
Information provided by (Responsible Party):
Shandong Lanjin Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01656980
First received: August 1, 2012
Last updated: August 2, 2012
Last verified: August 2012
  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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Newly Diagnosed Malignant Glioma

Resource links provided by NLM:


Further study details as provided by Shandong Lanjin Pharmaceuticals Co.,Ltd:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progress Free Survival [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Overall Survival Rate at 12 months [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Karnofsky Performance Status(KPS) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Quality of Life(QOL) [ Time Frame: 15 months ] [ Designated as safety issue: No ]
  • Safety of intracranially implanted carmustine after maximal tumor resection [ Time Frame: 15 months ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 236
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01656980

Contacts
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
China, Beijing
Beijing Tiantan Hospital Affiliated to Capital Medical University Not yet recruiting
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
Principal Investigator: Yan H Sun, M.D. Beijing Tiantan Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Shandong Lanjin Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier: NCT01656980     History of Changes
Other Study ID Numbers: LJ-Glioma 3. 3.0 Version
Study First Received: August 1, 2012
Last Updated: August 2, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Astrocytoma
Glioblastoma
Oligodendroglioma
Glioma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Carmustine
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014