Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03796507
Other study ID # RSRB00003258
Secondary ID
Status Withdrawn
Phase Early Phase 1
First received
Last updated
Start date September 1, 2021
Est. completion date December 15, 2021

Study information

Verified date April 2021
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 15, 2021
Est. primary completion date December 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Temozolomide
oral temozolomide at 75 mg per square meter of body surface area daily for 21 days

Locations

Country Name City State
United States University of Rochester Medical Center Rochester New York

Sponsors (2)

Lead Sponsor Collaborator
University of Rochester National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 month
Secondary 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. 1 month
Secondary 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. 1 month
See also
  Status Clinical Trial Phase
Withdrawn NCT04406610 - CAR-T Cell Immunotherapy for GD2 Positive Glioma Patients Phase 1/Phase 2
Active, not recruiting NCT03665545 - Pembrolizumab in Association With the IMA950/Poly-ICLC for Relapsing Glioblastoma Phase 1/Phase 2
Active, not recruiting NCT03189420 - Glioma Microenvironment an Exploratory Study
Completed NCT03194906 - Memantine for Prevention of Cognitive Late Effects in Pediatric Patients Receiving Cranial Radiation Therapy for Localized Brain Tumors Phase 2
Active, not recruiting NCT03739372 - Clinical Benefit of Using Molecular Profiling to Determine an Individualized Treatment Plan for Patients With High Grade Glioma N/A
Completed NCT03779230 - Safety and Efficacy of L19TNF in Patients With Isocitrate Dehydrogenase (IDH) Wildtype WHO Grade III / IV Glioma at First Relapse Phase 1/Phase 2
Recruiting NCT03728673 - A Study Utilizing Escitalopram in Glioma Patients Phase 2
Active, not recruiting NCT03496181 - Evaluation of Functional Magnetic Resonance Imaging (fMRI) in Patients Who Speak Two Languages Fluently
Recruiting NCT03180697 - The Efficacy of APT Magnetic Resonance Imaging in Predicting the Efficacy of Bevacizumab in Recurrent Malignant Gliomas N/A
Recruiting NCT03949192 - Efficacy of Kangliuwan for Recurrent Grade IV Glioma
Terminated NCT03927274 - Intratumorally-Administered Topotecan Using Convection-Enhanced Delivery in Patients With Grade III/ IV Glioma Early Phase 1
Recruiting NCT03213002 - Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM Phase 1/Phase 2
Not yet recruiting NCT03763396 - Azoles Targeting Recurrent High Grade Gliomas Early Phase 1
Terminated NCT03698201 - Blood Biomarker Signature in Glioma
Terminated NCT03436433 - Seizure Prophylaxis in Patients With Glioma or Brain Metastasis Phase 2
Recruiting NCT03750890 - Visual Study of Molecular Genotype in Glioma Evolution
Enrolling by invitation NCT03102112 - Noninvasively Predicting Gene Status of Glioma N/A
Active, not recruiting NCT03935685 - Pilot Study of Mirtazapine for the Dual Tx of Depression and CINV in High-Grade Glioma Pts on TMZ Phase 2
Completed NCT03834740 - A Phase 0 /II Study of Ribociclib (LEE011) in Combination With Everolimus in Preoperative Recurrent High-Grade Glioma Patients Scheduled for Resection Early Phase 1
Recruiting NCT03849430 - Longitudinal Analysis of the Health-related Quality of Life in Glioma Patients