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

Sponsor
Shandong Lanjin Pharmaceuticals Co.,Ltd (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01656980
Collaborator
(none)
236
Enrollment
1
Location
2
Arms
28
Duration (Months)
8.4
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
Anticipated 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 :
Aug 1, 2012
Anticipated Primary Completion Date :
Aug 1, 2014
Anticipated Study Completion Date :
Dec 1, 2014

Arms and Interventions

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 Names:
  • blank control group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival [15 months]

    Secondary Outcome Measures

    1. Progress Free Survival [15 months]

    2. Overall Survival Rate at 12 months [15 months]

    3. Karnofsky Performance Status(KPS) [15 months]

    4. Quality of Life(QOL) [15 months]

    5. Safety of intracranially implanted carmustine after maximal tumor resection [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

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Beijing Tiantan Hospital Affiliated to Capital Medical University Beijing Beijing China 100050

    Sponsors and Collaborators

    • Shandong Lanjin Pharmaceuticals Co.,Ltd

    Investigators

    • Principal Investigator: Yan H Sun, M.D., Beijing Tiantan Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shandong Lanjin Pharmaceuticals Co.,Ltd
    ClinicalTrials.gov Identifier:
    NCT01656980
    Other Study ID Numbers:
    • LJ-Glioma 3. 3.0 Version
    First Posted:
    Aug 3, 2012
    Last Update Posted:
    Aug 3, 2012
    Last Verified:
    Aug 1, 2012
    Additional relevant MeSH terms:
    Glioblastoma
    Glioma
    Astrocytoma
    Oligodendroglioma
    Carmustine

    Study Results

    No Results Posted as of Aug 3, 2012