Early Temozolomide in Patients With High-Grade Gliomas in Rehabilitation
Withdrawn before enrolling · Early Phase 1
Conditions studied: Glioma of Brain
In brief
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 patients who qualify for inpatient rehabilitation, as this population is particularly vulnerable to delays in initiation of chemoradiation and further tumor growth in the period between surgical resection and the start of treatment.
Key facts
- Study ID
- NCT03796507
- Run by
- University of Rochester
- People needed
- 0
- Starts
- 2021-09-01
- Expected to finish
- 2021-12-15
- Last updated by the study team
- 2021-04-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Rochester Medical Center — Rochester, New York, United States
Full record on ClinicalTrials.gov
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