Early Temozolomide in Patients With High-Grade Gliomas in Rehabilitation

NCT ID: NCT03796507

Last Updated: 2021-04-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2021-12-15

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.

Conditions

Glioma of Brain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 21 days before progressing to standard chemoradiation treatment.

Group Type: EXPERIMENTAL

Temozolomide

Intervention Type: DRUG

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

Interventions

Temozolomide

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Kevin Walter

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kevin A Walter, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester Medical Center, Dept. of Neurosurgery

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Other Identifiers

RSRB00003258

Identifier Type: -

Identifier Source: org_study_id