NCT00919737

Brief Summary

The purpose of this study is to evaluate whether NPC-08 is safety and efficacy in the treatment of newly-diagnosed malignant glioma and recurrent glioblastoma multiforme.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

Status
completed

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, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

October 30, 2013

Status Verified

October 1, 2013

Enrollment Period

1.8 years

First QC Date

June 10, 2009

Last Update Submit

October 29, 2013

Conditions

Malignant Glioma

Keywords

NPC-08carmustinenitrosoureasafety

Outcome Measures

Primary Outcomes (1)

  • Overall survival to 12 months

    12 months

Secondary Outcomes (1)

  • Progression-free survival

    12 months

Study Arms (1)

NPC-08

EXPERIMENTAL
Drug: NPC-08

Interventions

NPC-08DRUG

Polifeprosan 20 with Carmustine 3.85%

NPC-08

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female, aged between 18 and 65 years;
  • Radiographic evidence on cranial MRI of a single contrast-enhancing unilateral supratentorial cerebral tumor;
  • Karnofsky Performance Score of 60 or higher;
  • Willing to practice an effective method of birth control for at least 12 months after wafer implantation surgery;

You may not qualify if:

  • More than one focus of tumor or tumor crossing the midline, as assessed by coronal cranial MRI scan;
  • Prior radiotherapy to the brain;
  • Prior chemotherapy for the malignant glioma before the baseline evaluation, or patients who were being treated with chemotherapeutic agents;
  • Known hypersensitivity to nitrosoureas;
  • Participation in any other investigational protocol in the previous 6 months for any type of malignancy;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Tazuke Kofukai Foundation Medical Research Kitano Hospital

Osaka, Osaka, Japan

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Masao Mastutani, M.D., D.M.Sci.

    Saitama International Medical Center, Saitama Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2009

First Posted

June 12, 2009

Study Start

June 1, 2009

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

October 30, 2013

Record last verified: 2013-10

Locations

JP(1)