Last updated: August 8, 2022
Sponsor: Global Neurosciences Institute
Overall Status: Active - Recruiting
Phase
1
Condition
Glioblastoma Multiforme
Gliomas
Astrocytoma
Treatment
N/AClinical Study ID
NCT02285959
GlobalNI
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histologically confirmed diagnosis of GBM
- Grade IV GBM tumors that have recurred after total resection
- Age > 18 years
- At least four weeks following any recent surgery
- Patients must have a Karnofsky performance status ≥60% and an expected survival of ≥three months.
- No IV chemotherapy for three weeks prior to treatment under this research protocol andno external beam radiation for four weeks prior to treatment under this researchprotocol.
- Patients must have adequate hematologic reserve
- Pre-enrollment coagulation parameters (PT and PTT) must be adequate.
- Patients must agree to use a medically effective method of contraception during andfor a period of three months after the treatment period. A pregnancy test will beperformed on each premenopausal female of childbearing potential immediately prior toentry into the research study.
- Patients must be able to understand and give written informed consent. Informedconsent must be obtained at the time of patient screening.
Exclusion
Exclusion Criteria:
- Women who are pregnant or lactating.
- Women of childbearing potential and fertile men will be informed as to the potentialrisk of procreation while participating in this research trial and will be advisedthat they must use effective contraception during and for a period of three monthsafter the treatment period.
- Patients with significant intercurrent medical or psychiatric conditions that wouldplace them at increased risk or affect their ability to receive or comply withtreatment or post-treatment clinical monitoring.
Study Design
Total Participants: 30
Study Start date:
June 01, 2014
Estimated Completion Date:
June 30, 2025
Connect with a study center
Capital Institute for Neurosciences
Trenton, New Jersey 08638
United StatesSite Not Available
Philadelphia, Pennsylvania
United StatesActive - Recruiting
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