Early Temozolomide in Patients With High-Grade Gliomas in Rehabilitation

• Status: Withdrawn
• Trial end date: 2021-12-15
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: National Institutes of Health (NIH)
• Treatments: Dacarbazine; Temozolomide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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