Status:
WITHDRAWN
Early Temozolomide in Patients With High-Grade Gliomas in Rehabilitation
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Glioma of Brain
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to investigate the feasibility of a possible treatment regimen that could be used to delay tumor progression in patients with glioblastoma. The study is being conducted in...
Detailed Description
This is a pilot study to evaluate the feasibility and safety of early postsurgical temozolomide therapy prior to initiation of standard chemoradiation regimen in patients with glioblastoma who undergo...
Eligibility Criteria
Inclusion
- Adult patients, aged 18+
- Newly diagnosed World Health Organization (WHO) Grade IV glioma, confirmed on pathology
- Karnofsky Performance Score ≥ 60
- Subject has undergone biopsy, subtotal resection, or gross total resection of tumor
- Subject has been evaluated by physical therapy and thought to be a candidate for acute rehabilitation
- Subject must be accepted for admission on 5-1200 unit at Strong Memorial Hospital
- Subject must be able to provide informed consent
- Subject must meet the following laboratory parameters:
- Absolute neutrophil count \> 1.5 x103/uL
- Platelet count \> 140 x103/uL
- Alanine transaminase \< 135 U/L
- Aspartate transaminase \< 120 U/L
Exclusion
- Subject has received previous treatment for high-grade glioma
- Subject has other active malignancy
- Subject is currently pregnant or breastfeeding
- Subject is a women of childbearing potential who is not using a reliable method of contraception
- Subject has history of hypersensitivity to temozolomide
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03796507
Start Date
September 1 2021
End Date
December 15 2021
Last Update
April 9 2021
Active Locations (1)
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1
University of Rochester Medical Center
Rochester, New York, United States, 14642