Back to resultsSafety and Efficacy Study of Intracranially Implanted Carmustine to Treat Recurrent Malignant Glioma
Primary Purpose
Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Anaplastic Oligoastrocytoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Carmustine(BCNU)
Surgery
Sponsored by
About this trial
This is an interventional treatment trial for Anaplastic Astrocytoma
Eligibility Criteria
Inclusion Criteria:
- 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(exclude patients with little tumors near the resectable tumor even if investigators think they are single lesions)
- No obvious important organ dysfunction: Blood routine: White blood cell (WBC) ≥ 4.0×109/L, Absolute neutrophil count (ANC)≥ 1.5×109/L, Platelets≥ 100×109/L, Hemoglobin≥ 90 g/L; 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:
- Tumor located at ventricular system, Open ventricle tumor cavity postoperatively;
- Concomitant with other life-threatening diseases and with life expectancy <3 months;
- Allergic to nitrosourea drugs;
- With history of intracranial radiotherapy or implant chemotherapy;
- With serious cardiac, pulmonary, hepatic and renal dysfunction, poor glycemic control;
- Investigators thought unsuitable for enrollment.
Sites / Locations
- Sun Yat-Sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Carmustine Sustained Release Implant
Surgical control group
Arm Description
Outcomes
Primary Outcome Measures
Overall Survival
Secondary Outcome Measures
Overall Survival Rate
Progress Free Survival Rate at 6 months
Tumor response rate
KPS Score
QOL Score
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 presure, temperature, respiratory rate , heart rate.
Full Information
NCT ID
NCT01637753
First Posted
July 4, 2012
Last Updated
July 8, 2012
Sponsor
Shandong Lanjin Pharmaceuticals Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01637753
Brief Title
Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Recurrent Malignant Glioma
Official Title
Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Recurrent Malignant Glioma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
December 2013 (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 recurrent 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 recurrent malignant glioma in 212 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
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Carmustine Sustained Release Implant
Arm Type
Experimental
Arm Title
Surgical control group
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
Carmustine(BCNU)
Other Intervention Name(s)
BCNU
Intervention Description
Carmustine Sustained Release Implant
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
Routine tumor resection surgery
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Overall Survival Rate
Time Frame
12 months
Title
Progress Free Survival Rate at 6 months
Time Frame
12 months
Title
Tumor response rate
Time Frame
12 months
Title
KPS Score
Time Frame
12 months
Title
QOL Score
Time Frame
12 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 presure, temperature, respiratory rate , heart rate.
Time Frame
12 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:
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(exclude patients with little tumors near the resectable tumor even if investigators think they are single lesions)
No obvious important organ dysfunction: Blood routine: White blood cell (WBC) ≥ 4.0×109/L, Absolute neutrophil count (ANC)≥ 1.5×109/L, Platelets≥ 100×109/L, Hemoglobin≥ 90 g/L; 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:
Tumor located at ventricular system, Open ventricle tumor cavity postoperatively;
Concomitant with other life-threatening diseases and with life expectancy <3 months;
Allergic to nitrosourea drugs;
With history of intracranial radiotherapy or implant chemotherapy;
With serious cardiac, pulmonary, hepatic and renal dysfunction, poor glycemic control;
Investigators thought unsuitable for enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong P Chen, M.D.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-Sen University Cancer Center
City
Guangzhou
State/Province
Guangzhou
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhong P Chen, M.D.
Phone
+86-1350-0002-457
Ext
+86-0208734331
Email
chenzhp@sysucc.org.cn
First Name & Middle Initial & Last Name & Degree
Li Wu, Bachelor
Phone
+86-1392-5050-815
Email
wul@lanjin.cn
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Recurrent Malignant Glioma
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