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Study of NPC-08 is to Treat for Newly-Diagnosed Malignant Glioma and Recurrent Glioblastoma Multiforme

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 64 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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;

Exclusion Criteria:

- 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;

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT00919737
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1/Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Nobelpharma
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Masao Mastutani, M.D., D.M.Sci.
Principal Investigator Affiliation	Saitama International Medical Center, Saitama Medical University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Completed
Countries	Japan
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Malignant Glioma

Arms & Interventions

Arms

Experimental: NPC-08

Interventions

Drug: - NPC-08

Polifeprosan 20 with Carmustine 3.85%

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Osaka, Japan

Status

Address

The Tazuke Kofukai Foundation Medical Research Kitano Hospital

Osaka, ,

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