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
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.
Obtaining MTD and safety profile of daily HU+TMZ in patients with rGBM;
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
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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