Safety and Efficacy Study of Intracranially Implanted Carmustine to Treat Recurrent Malignant Glioma
This study is currently recruiting participants.
Verified July 2012 by Shandong Lanjin Pharmaceuticals Co.,Ltd
Sponsor:
Shandong Lanjin Pharmaceuticals Co.,Ltd
Information provided by (Responsible Party):
Shandong Lanjin Pharmaceuticals Co.,Ltd
ClinicalTrials.gov Identifier:
NCT01637753
First received: July 4, 2012
Last updated: July 8, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anaplastic Oligoastrocytoma Glioblastoma |
Drug: Carmustine(BCNU) Procedure: Surgery |
| 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 Recurrent 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: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall Survival Rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Progress Free Survival Rate at 6 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Tumor response rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- KPS Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- QOL Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Safety of intracranially implanted carmustine after maximal tumor resection [ Time Frame: 12 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 presure, temperature, respiratory rate , heart rate.
| Estimated Enrollment: | 212 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Carmustine Sustained Release Implant |
Drug: Carmustine(BCNU)
Carmustine Sustained Release Implant
Other Name: BCNU
|
| Sham Comparator: Surgical control group |
Procedure: Surgery
Routine tumor resection surgery
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637753
Locations
| China, Guangzhou | |
| Sun Yat-Sen University Cancer Center | Recruiting |
| Guangzhou, Guangzhou, China, 510060 | |
| Contact: Zhong P Chen, M.D. +86-1350-0002-457 ext +86-0208734331 chenzhp@sysucc.org.cn | |
| Contact: Li Wu, Bachelor +86-1392-5050-815 wul@lanjin.cn | |
Sponsors and Collaborators
Shandong Lanjin Pharmaceuticals Co.,Ltd
Investigators
| Principal Investigator: | Zhong P Chen, M.D. | Sun Yat-sen University |
More Information
No publications provided
| Responsible Party: | Shandong Lanjin Pharmaceuticals Co.,Ltd |
| ClinicalTrials.gov Identifier: | NCT01637753 History of Changes |
| Other Study ID Numbers: | LJ-Glioma 3.1.0 Version |
| Study First Received: | July 4, 2012 |
| Last Updated: | July 8, 2012 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Astrocytoma Glioblastoma Oligodendroglioma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Carmustine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013