Ignite Creation Date:
2024-05-06 @ 11:13 AM
Last Modification Date:
2024-10-26 @ 12:42 PM
Study NCT ID:
NCT03463733
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2018-03-01
Brief Title:
Hydroxy-urea and Temozolomide in Patients With a Recurrent Malignant Brain Tumor Glioblastoma
Sponsor:
ME van Linde
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
International Multicenter Phase I Trial of Hydroxyurea in Combination With Dose-Intense Temozolomide in Recurrent Glioblastoma
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HUTMZ
Brief 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 HUTMZ 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 HUTMZ 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 HUTMZ
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 HUTMZ 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 HUTMZ 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 HUTMZ
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None