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:
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
  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 April 23, 2014