Clinical trial NCT03796507: 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
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Glioma of Brain
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2019-01-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The number of patient who fail to complete temozolomide (TMZ)
timeFrame: 1 month
Secondary outcomes:
measure: Mean functional independence measure (FIM) score
timeFrame: 1 month
measure: Response rate to TMZ
timeFrame: 1 month
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester Medical Center, Dept. of Neurosurgery
name: Kevin A Walter, MD
role: PRINCIPAL_INVESTIGATOR
References: