Early Temozolomide in Patients With High-Grade Gliomas in Rehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03796507
Recruitment Status : Not yet recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Kevin Walter, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Glioma of Brain Drug: Temozolomide Early Phase 1

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 receive a single 5-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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Post-surgical Temozolomide Therapy in Patients With High-Grade Gliomas Admitted to Acute Rehabilitation: A Feasibility Study
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
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 5 days.
Drug: Temozolomide
oral temozolomide at 75 mg per square meter of body surface area daily for 5 days

Primary Outcome Measures :
  1. The number of patient who fail to complete temozolomide (TMZ) [ Time Frame: 1 month ]
    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 :
  1. Mean functional independence measure (FIM) score [ Time Frame: 1 month ]
    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.

  2. Response rate to TMZ [ Time Frame: 1 month ]
    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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03796507

Contact: Kwanza Warren 585-276-3581

United States, New York
University of Rochester Medical Center Not yet recruiting
Rochester, New York, United States, 14642
Contact: Kwanza Warren    585-276-3581   
Sponsors and Collaborators
University of Rochester
National Institutes of Health (NIH)
Principal Investigator: Kevin A Walter, MD University of Rochester Medical Center, Dept. of Neurosurgery

Responsible Party: Kevin Walter, Professor, University of Rochester Identifier: NCT03796507     History of Changes
Other Study ID Numbers: RSRB00003258
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents