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

August 2, 2012 updated by: Shandong Lanjin Pharmaceuticals Co.,Ltd

Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Newly Diagnosed Malignant Glioma

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

236

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jian J Yu, Master
  • Phone Number: +86-15336402751
  • Email: yujj@lanjin.cn

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100050
        • Beijing Tiantan Hospital Affiliated to Capital Medical University
        • Contact:
        • Contact:
          • Jian J Yu, Master
          • Phone Number: +86-15336402751
          • Email: yujj@lanjin.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 15 months
15 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progress Free Survival
Time Frame: 15 months
15 months
Overall Survival Rate at 12 months
Time Frame: 15 months
15 months
Karnofsky Performance Status(KPS)
Time Frame: 15 months
15 months
Quality of Life(QOL)
Time Frame: 15 months
15 months
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.
15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Lanjin Pharmaceuticals Co.,Ltd

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

August 1, 2012

First Submitted That Met QC Criteria

August 2, 2012

First Posted (Estimate)

August 3, 2012

Study Record Updates

Last Update Posted (Estimate)

August 3, 2012

Last Update Submitted That Met QC Criteria

August 2, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LJ-Glioma 3. 3.0 Version

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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