International study in multiple centers studying the effect of hydroxy-urea and temozolomide chemotherapy in patients with a recurrent malignant brain tumor (Glioblastoma)

• Conditions: Brain tumor, glioma, glioblastoma, recurrent glioblastoma, glioblastoma multiformeHersentumor, glioom, glioblastoom, recidief glioblastoom, glioblastoma multiforme

• Registration Number: NL-OMON20720
• Lead Sponsor: VU University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

1. Participants must have histologically or cytologically confirmed glioblastoma multiforme

2. Patients may have had any number of prior therapies for glioblastoma. Patients must be at least 28 days from any investigational agent, 28 days from prior cytotoxic therapy (except 23 days from prior temozolomide, 14 days from vincristine, 42 days from nitrosoureas, 21 days from procarbazine administration), and 7 days for patients who received metronomic chemotherapy or non-cytotoxic agents, e.g., interferon, tamoxifen, thalidomide, cis-retinoic acid, etc.

Exclusion Criteria

1. Participants who are receiving any other investigational agents or devices in investigation for glioblastoma.

2. Patients must not have been previously treated with an anti-VEGF inhibitor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the maximimum tolerated dose (MTD) and safety profile of daily hydroxyurea in combination with continuous dose-intense temozolomide in patients with recurrent GBM.

Secondary Outcome Measures

Name	Time	Method
To estimate the preliminary median progression-free survival of patients with recurrent glioblastoma treated with daily hydroxyurea in combination with dose-intense temozolomide.<br>To estimate the preliminary radiographic response proportion in patients with measurable disease. <br /><br>To estimate the preliminary median overall survival.<br /><br>Exploratory correlation of treatment outcomes (progression-free and overall survival with MGMT promoter methylation status in archival tumor specimens.