Clinical trial · Interventional
Early Temozolomide in Patients With High-Grade Gliomas in Rehabilitation
Early Post-surgical Temozolomide Therapy in Patients With High-Grade Gliomas Admitted to Acute Rehabilitation: A Feasibility Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Hiring freeze of research personnel due to COVID pandemic
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma of Brain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Temozolomide Arm
- description
- This study will only include one treatment group who will receive oral temozolomide at 75 mg per square meter of body surface area daily for 21 days before progressing to standard chemoradiation treatment.
- interventionNames
- Drug: Temozolomide
Primary outcomes (1)
- measure
- The number of patient who fail to complete temozolomide (TMZ)
- timeFrame
- 1 month
- description
- The number of subjects who fail to complete early TMZ plus inpatient rehabilitation for any reason, including adverse events or progression or patient withdrawal
Secondary outcomes (2)
- measure
- Mean functional independence measure (FIM) score
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available