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Clinical Trial Summary

Background

Currently, no standard treatment exists for patients with recurrent glioblastoma multiforme (rGBM) and used 2nd line treatments have low (up to max. 20%) response rates and very modest response duration (months). The median overall survival for GBM patients is 12-14 months from the time of diagnosis; therefore the development of new therapeutic options is imperative. HU has been used to treat hematological diseases and solid tumors (such as melanoma, ovarian, squamous cell carcinoma, head and neck carcinoma and brain tumors) in combination with other anti-cancer agents, but never with TMZ. If found safe, HU+TMZ, is easily translated to the clinic.

Purpose: Phase I trial to identify the maximum tolerated dose (MTD) for the combination of dose intense temozolomide (TMZ) and hydroxy-urea (HU) in (maximal) thirty patients with recurrent glioblastoma (rGBM).

Plan of investigation:

Month 0-24 (1st and 2nd year): Inclusion and follow-up of a maximum of 30 patients with rGBM

Month 25-31 (3rd year): Follow-up of patients included in the trial, data analysis (determining MTD and explorative analysis) and manuscript preparation.

Possible results:

1. Obtaining MTD and safety profile of daily HU+TMZ in patients with rGBM;

2. Preliminary data on the estimation of the median progression-free (PFS) and overall survival (OS), radiographic response proportion in patients with measurable disease, and exploratory correlation of treatment outcomes (PFS and OS) with o6-methylguanine-DNA-methyltransferase (MGMT) promoter methylation status in archival tumor specimens and further elucidation of underlying mechanism of re-sensitization of TMZ by HU. Exploratory analysis of biomarkers profile of platelets in patients treated with HU+TMZ.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03463733
Study type Interventional
Source VU University Medical Center
Contact Jelle Arts
Phone +31 (0)20 4444254
Email trialoffice-onc@vumc.nl
Status Recruiting
Phase Phase 1
Start date March 2, 2018
Completion date June 1, 2022

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