NCT01637753

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

July 11, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

July 4, 2012

Last Update Submit

July 8, 2012

Conditions

Anaplastic AstrocytomaAnaplastic OligodendrogliomaAnaplastic OligoastrocytomaGlioblastoma

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    12 months

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Carmustine Sustained Release Implant

EXPERIMENTAL
Drug: Carmustine(BCNU)

Surgical control group

SHAM COMPARATOR
Procedure: Surgery

Interventions

Carmustine(BCNU)DRUG

Carmustine Sustained Release Implant

Also known as: BCNU
Carmustine Sustained Release Implant
SurgeryPROCEDURE

Routine tumor resection surgery

Surgical control group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangzhou, 510060, China

RECRUITING

MeSH Terms

Conditions

AstrocytomaOligodendrogliomaGlioblastoma

Interventions

CarmustineSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

GliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso Compounds

Study Officials

  • Zhong P Chen, M.D.

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2012

First Posted

July 11, 2012

Study Start

June 1, 2012

Primary Completion

June 1, 2013

Study Completion

December 1, 2013

Last Updated

July 11, 2012

Record last verified: 2012-07

Locations

CN(1)