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Early Temozolomide in Patients With High-Grade Gliomas in Rehabilitation

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03796507
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Early Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Rochester
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Kevin A Walter, MD
Principal Investigator Affiliation University of Rochester Medical Center, Dept. of Neurosurgery
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Withdrawn
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioma of Brain
Additional Details

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.

Arms & Interventions

Arms

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 21 days before progressing to standard chemoradiation treatment.

Interventions

Drug: - Temozolomide

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Rochester Medical Center, Rochester, New York

Status

Address

University of Rochester Medical Center

Rochester, New York, 14642

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