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

Phase 3 Study of Carmustine Sustained Release Implant (CASANT) to Treat Recurrent Malignant Glioma

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.

Study Overview

• Status: Unknown
• Conditions: Glioblastoma; Anaplastic Oligoastrocytoma; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma
• Intervention / Treatment: Drug: Carmustine(BCNU); Procedure: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 212
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangzhou
    • Guangzhou, Guangzhou, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Zhong P Chen, M.D.; Phone Number: +86-0208734331 +86-1350-0002-457; Email: chenzhp@sysucc.org.cn
      • Contact: Li Wu, Bachelor; Phone Number: +86-1392-5050-815; Email: wul@lanjin.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Carmustine Sustained Release Implant	Drug: Carmustine(BCNU); Carmustine Sustained Release Implant; Other Names: BCNU
SHAM_COMPARATOR: Surgical control group	Procedure: Surgery; Routine tumor resection surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival Rate		12 months
Progress Free Survival Rate at 6 months		12 months
Tumor response rate		12 months
KPS Score		12 months
QOL Score		12 months
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.	12 months

Collaborators and Investigators

• Sponsor: Shandong Lanjin Pharmaceuticals Co.,Ltd
• Investigators: Principal Investigator: Zhong P Chen, M.D., Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ANTICIPATED): June 1, 2013
• Study Completion (ANTICIPATED): December 1, 2013

Study Registration Dates

• First Submitted: July 4, 2012
• First Submitted That Met QC Criteria: July 8, 2012
• First Posted (ESTIMATE): July 11, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 11, 2012
• Last Update Submitted That Met QC Criteria: July 8, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma; Glioma; Astrocytoma; Oligodendroglioma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Alkylating; Alkylating Agents; Carmustine
• Other Study ID Numbers: LJ-Glioma 3.1.0 Version