search
Back to results

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

Primary Purpose

Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Carmustine
tumor resection surgery
Sponsored by
Shandong Lanjin Pharmaceuticals Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anaplastic Astrocytoma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Tiantan Hospital Affiliated to Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Carmustine Sustained Release Implant

Tumor Resection Surgery

Arm Description

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

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

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Progress Free Survival
Overall Survival Rate at 12 months
Karnofsky Performance Status(KPS)
Quality of Life(QOL)
Safety of intracranially implanted carmustine after maximal tumor resection
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.

Full Information

First Posted
August 1, 2012
Last Updated
August 2, 2012
Sponsor
Shandong Lanjin Pharmaceuticals Co.,Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT01656980
Brief Title
Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Newly Diagnosed Malignant Glioma
Official Title
Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Newly Diagnosed Malignant Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shandong Lanjin Pharmaceuticals Co.,Ltd

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma, Glioblastoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
236 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carmustine Sustained Release Implant
Arm Type
Experimental
Arm Description
For subjects in this group, they will accept intracranially implanted carmustine intraoperatively.
Arm Title
Tumor Resection Surgery
Arm Type
Sham Comparator
Arm Description
For subjects in this control group, they accept no implants while gliomas maximally be resected.
Intervention Type
Drug
Intervention Name(s)
Carmustine
Other Intervention Name(s)
Trade name: CASANT, Other name: BCNU
Intervention Description
As Experimental group, subjects will accept specified wafers of carmustine in the cavity while gliomas maximally be resected.
Intervention Type
Procedure
Intervention Name(s)
tumor resection surgery
Other Intervention Name(s)
blank control group
Intervention Description
For this group, subjects will accept routine tumor resection surgery and place no implant wafers.
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
15 months
Secondary Outcome Measure Information:
Title
Progress Free Survival
Time Frame
15 months
Title
Overall Survival Rate at 12 months
Time Frame
15 months
Title
Karnofsky Performance Status(KPS)
Time Frame
15 months
Title
Quality of Life(QOL)
Time Frame
15 months
Title
Safety of intracranially implanted carmustine after maximal tumor resection
Description
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.
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan H Sun, M.D.
Phone
+86-1360-1389-945
Email
sunyanhui1109@yahoo.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jian J Yu, Master
Phone
+86-15336402751
Email
yujj@lanjin.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan H Sun, M.D.
Organizational Affiliation
Beijing Tiantan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tiantan Hospital Affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan H Sun, M.D.
Phone
+86-1360-1389-945
Email
sunyanhui1109@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Jian J Yu, Master
Phone
+86-15336402751
Email
Yujj@lanjin.cn

12. IPD Sharing Statement

Links:
URL
http://lanjin.cn
Description
You will see subjects recruitment information when visiting above website.

Learn more about this trial

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

We'll reach out to this number within 24 hrs