Early Temozolomide in Patients With High-Grade Gliomas in Rehabilitation
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|ClinicalTrials.gov Identifier: NCT03796507|
Recruitment Status : Not yet recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioma of Brain||Drug: Temozolomide||Early Phase 1|
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 inpatient rehabilitation. The study will be conducted with adult patients who qualify for inpatient rehabilitation following surgical resection of pathologically confirmed Grade IV glioma. Patients will receive a single 5-day cycle of temozolomide starting 14 days after surgery at 75mg per square meter of body surface area daily to serve as bridge therapy. Patients will then progress to receive standard therapy following their rehabilitation stay. Patients will be assessed for their ability to complete the chemotherapy protocol without dose-limiting toxicity as well as complete inpatient rehabilitation successfully. Additionally, we will be assessing for tumor progression between the time of surgery and the time of treatment initiation.
If this study shows the expected results, the research team plans to proceed to a larger trial assessing the efficacy of early TMZ in patients with glioblastoma (GBM) who are admitted to acute inpatient rehabilitation compared to the current standard of care.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Post-surgical Temozolomide Therapy in Patients With High-Grade Gliomas Admitted to Acute Rehabilitation: A Feasibility Study|
|Estimated Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||February 1, 2020|
|Estimated Study Completion Date :||February 1, 2020|
Experimental: Temozolomide Arm
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 5 days.
oral temozolomide at 75 mg per square meter of body surface area daily for 5 days
- The number of patient who fail to complete temozolomide (TMZ) [ Time Frame: 1 month ]The number of subjects who fail to complete early TMZ plus inpatient rehabilitation for any reason, including adverse events or progression or patient withdrawal
- Mean functional independence measure (FIM) score [ Time Frame: 1 month ]FIM is comprised of 18 items, grouped into 2 subscales -motor and cognition. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item therefore the better the health outcome. The total score for the FIM instrument (the sum of the motor and cognition subscale scores) will be a value between 18 and 126.
- Response rate to TMZ [ Time Frame: 1 month ]The response rate to early TMZ will be evaluated by comparing the MRI of the head before and after one course using the Response Assessment in Neuro-Oncology (RANO) criteria. The response rate will be reported with a (two-sided) 90% confidence interval. The RANO criteria consists of 5 elements: T1 Gadolinium enhancing disease, T2/FLAIR assessment, new lesions, use of corticosteroids and clinical status. Patients will be categorized as complete response, partial response, stable disease or progressive disease.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03796507
|Contact: Kwanza Warrenemail@example.com|
|United States, New York|
|University of Rochester Medical Center||Not yet recruiting|
|Rochester, New York, United States, 14642|
|Contact: Kwanza Warren 585-276-3581 firstname.lastname@example.org|
|Principal Investigator:||Kevin A Walter, MD||University of Rochester Medical Center, Dept. of Neurosurgery|