Ignite Creation Date:
2024-05-06 @ 4:14 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04926168
Status:
WITHDRAWN
Last Update Posted:
2022-08-10
First Post:
2021-06-08
Brief Title:
6 Months Adjuvant Temozolomide TMZ vs No Adjuvant TMZ in Newly Diagnosed MGMT Methylated Glioblastoma GBM
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Randomized Pilot Study of Six Months Adjuvant Temozolomide TMZ vs No Adjuvant TMZ in Patients With Newly Diagnosed MGMT Methylated Glioblastoma GBM Following Standard Concurrent Radiation and TMZ
Status:
WITHDRAWN
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of funds
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this trial is to evaluate overall survival of patients with O6-methylguanine-DNA methyltransferase MGMT methylated glioblastoma treated with or without six months of adjuvant TMZ after standard radiation 6000 centigray cGy plus concurrent Temozolomide TMZ
Secondary Objectives include to prospectively assess the overall adverse event profile in the two treatment arms To compare lymphocyte counts overtime between the two treatment arms and to prospectively compare quality of life in the two treatment arms as assessed by MD Anderson Symptom Inventory-Brain Tumor Module MDASI-BT and Neurological quality of Lifeminimal infecting dose NeuroQoL MID The study will also compare progression-free survival between the two treatment arms
Secondary Objectives include to prospectively assess the overall adverse event profile in the two treatment arms To compare lymphocyte counts overtime between the two treatment arms and to prospectively compare quality of life in the two treatment arms as assessed by MD Anderson Symptom Inventory-Brain Tumor Module MDASI-BT and Neurological quality of Lifeminimal infecting dose NeuroQoL MID The study will also compare progression-free survival between the two treatment arms
Detailed Description:
Recent phase III trials in patients with newly diagnosed patients with glioblastoma have demonstrated that adding new agents such as cilengitide bevacizumab or nivolumab to standard radiation and TMZ do not improve survival in this disease The modest effects on survival observed with the Optune device are offset by the high costs inconvenience and impact on the social interactions of patients wearing this device Unfortunately there are currently no novel therapies poised to displace the European Organization Research Treatment Cancer EORTC regimen as the standard of care for patients with newly diagnosed Glioblastoma Multiforme GBMAs a result a formal evaluation of the efficacy of the 6 months of adjuvant TMZ in this regimen is important to patients and research studies
This is of particular importance in the 40 of patients who have MGMT methylated glioblastoma The very small benefit observed in MGMT unmethylated patients has led investigators in Europe and the United States of America including Cancer Therapy Evaluation Program CTEP sponsored studies to approve clinical trials in MGMT unmethylated patients with newly diagnosed glioblastoma that entirely omit TMZ in both the concurrent and the adjuvant settings Given the marginal value of TMZ in the MGMT unmethylated patient population the investigators propose to study the value of adjuvant TMZ in the subset of the MGMT methylated population If omitting adjuvant TMZ is not detrimental to outcomes in the methylated population then it is extremely unlikely to benefit the unmethylated population where TMZ has even less effect
Therefore exploring the value of the six months of adjuvant TMZ in patients with newly diagnosed MGMT methylated glioblastoma is important If this was shown to be of minimal value in prolonging survival there would be an immediate impact on both the standard care of patients and research efforts to improve therapeutic outcomes
This is of particular importance in the 40 of patients who have MGMT methylated glioblastoma The very small benefit observed in MGMT unmethylated patients has led investigators in Europe and the United States of America including Cancer Therapy Evaluation Program CTEP sponsored studies to approve clinical trials in MGMT unmethylated patients with newly diagnosed glioblastoma that entirely omit TMZ in both the concurrent and the adjuvant settings Given the marginal value of TMZ in the MGMT unmethylated patient population the investigators propose to study the value of adjuvant TMZ in the subset of the MGMT methylated population If omitting adjuvant TMZ is not detrimental to outcomes in the methylated population then it is extremely unlikely to benefit the unmethylated population where TMZ has even less effect
Therefore exploring the value of the six months of adjuvant TMZ in patients with newly diagnosed MGMT methylated glioblastoma is important If this was shown to be of minimal value in prolonging survival there would be an immediate impact on both the standard care of patients and research efforts to improve therapeutic outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB00285623 | OTHER | Johns Hopkins University | None |