Early Temozolomide in Patients With High-Grade Gliomas in Rehabilitation

NCT03796507 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: RSRB00003258
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioma of Brain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Mean functional independence measure (FIM) score

  1 month

• Response rate to TMZ

  1 month

Study Arms (1)

Temozolomide Arm

EXPERIMENTAL

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.

Drug: Temozolomide

Interventions

Temozolomide DRUG

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

Temozolomide Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Interventions

Temozolomide

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kevin A Walter, MD

  University of Rochester Medical Center, Dept. of Neurosurgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 8, 2019
• Study Start: September 1, 2021
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: April 9, 2021

Record last verified: 2021-04

Locations

US (1)