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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01637753
Recruitment Status : Unknown
Verified July 2012 by Shandong Lanjin Pharmaceuticals Co.,Ltd.
Recruitment status was:  Recruiting
First Posted : July 11, 2012
Last Update Posted : July 11, 2012
Information provided by (Responsible Party):
Shandong Lanjin Pharmaceuticals Co.,Ltd

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.

Condition or disease Intervention/treatment Phase
Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anaplastic Oligoastrocytoma Glioblastoma Drug: Carmustine(BCNU) Procedure: Surgery Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Recurrent Malignant Glioma
Study Start Date : June 2012
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : December 2013

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Overall Survival Rate [ Time Frame: 12 months ]
  2. Progress Free Survival Rate at 6 months [ Time Frame: 12 months ]
  3. Tumor response rate [ Time Frame: 12 months ]
  4. KPS Score [ Time Frame: 12 months ]
  5. QOL Score [ Time Frame: 12 months ]
  6. Safety of intracranially implanted carmustine after maximal tumor resection [ Time Frame: 12 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 presure, temperature, respiratory rate , heart rate.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01637753

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   
Contact: Li Wu, Bachelor    +86-1392-5050-815   
Sponsors and Collaborators
Shandong Lanjin Pharmaceuticals Co.,Ltd
Principal Investigator: Zhong P Chen, M.D. Sun Yat-sen University

Responsible Party: Shandong Lanjin Pharmaceuticals Co.,Ltd Identifier: NCT01637753     History of Changes
Other Study ID Numbers: LJ-Glioma 3.1.0 Version
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: July 11, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents