Early Temozolomide in Patients With High-Grade Gliomas in Rehabilitation
Primary Purpose
Glioma of Brain
Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Temozolomide
Sponsored by
About this trial
This is an interventional treatment trial for Glioma of Brain
Eligibility 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
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Temozolomide Arm
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.
Outcomes
Primary Outcome Measures
The number of patient who fail to complete temozolomide (TMZ)
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 Outcome Measures
Mean functional independence measure (FIM) score
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
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.
Full Information
NCT ID
NCT03796507
First Posted
January 4, 2019
Last Updated
April 6, 2021
Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT03796507
Brief Title
Early Temozolomide in Patients With High-Grade Gliomas in Rehabilitation
Official Title
Early Post-surgical Temozolomide Therapy in Patients With High-Grade Gliomas Admitted to Acute Rehabilitation: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Hiring freeze of research personnel due to COVID pandemic
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
December 15, 2021 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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.
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 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 begin a 21-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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioma of Brain
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Temozolomide Arm
Arm Type
Experimental
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.
Intervention Type
Drug
Intervention Name(s)
Temozolomide
Intervention Description
oral temozolomide at 75 mg per square meter of body surface area daily for 21 days
Primary Outcome Measure Information:
Title
The number of patient who fail to complete temozolomide (TMZ)
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
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Mean functional independence measure (FIM) score
Description
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.
Time Frame
1 month
Title
Response rate to TMZ
Description
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.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin A Walter, MD
Organizational Affiliation
University of Rochester Medical Center, Dept. of Neurosurgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Early Temozolomide in Patients With High-Grade Gliomas in Rehabilitation
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