Ignite Creation Date:
2024-05-06 @ 3:38 AM
Last Modification Date:
2024-10-26 @ 11:36 AM
Study NCT ID:
NCT02337426
Status:
COMPLETED
Last Update Posted:
2019-06-28
First Post:
2015-01-08
Brief Title:
Dimethyl Fumarate Temozolomide and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Sponsor:
Virginia Commonwealth University
Organization:
Virginia Commonwealth University
Study Overview
Official Title:
Phase I Trial of Dimethyl Fumarate Temozolomide and Radiation Therapy in Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
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:
None
Brief Summary:
This phase 1 trial studies the side effects and best dose of dimethyl fumarate when given together with temozolomide and radiation therapyRT in treating patients with newly diagnosed glioblastoma multiforme GBM Dimethyl fumarate may help radiation therapy work better by making tumor cells more sensitive to the radiation therapy Drugs used in chemotherapy such as temozolomide work in different ways to stop the growth of tumor cells either by killing the cells by stopping them from dividing or by stopping them from spreading Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors Giving dimethyl fumarate with temozolomide and radiation therapy may work better in treating glioblastoma multiforme
Detailed Description:
PRIMARY OBJECTIVES
I To determine the recommended phase 2 dose RP2D of dimethyl fumarate DMF when combined with standard concurrent temozolomide and RT in subjects with newly diagnosed glioblastoma multiforme GBM
SECONDARY OBJECTIVES
I To evaluate the safety tolerance and toxicity of DMF when combined with standard concurrent temozolomide and RT in subjects with newly diagnosed GBM
II To obtain a preliminary estimate of the efficacy of DMF when combined with standard concurrent temozolomide and RT in subjects with newly diagnosed GBM
OUTLINE This is a dose-escalation study of dimethyl fumarate
CONCOMITANT THERAPY Between 21 days 3 weeks and 42 days 6 weeks following the last surgical procedure patients receive temozolomide orally PO once daily QD for 42-49 days and dimethyl fumarate PO twice daily BID or thrice daily TID continuously Patients also undergo radiation therapy 5 days a week over 6 weeks for a total of 30 fractions
MAINTENANCE THERAPY Patients continue to receive dimethyl fumarate PO BID or TID continuously Four weeks after completing concomitant temozolomide and radiation therapy patients also receive temozolomide PO QD on days 1-5 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 30 days and then every 2 months thereafter
I To determine the recommended phase 2 dose RP2D of dimethyl fumarate DMF when combined with standard concurrent temozolomide and RT in subjects with newly diagnosed glioblastoma multiforme GBM
SECONDARY OBJECTIVES
I To evaluate the safety tolerance and toxicity of DMF when combined with standard concurrent temozolomide and RT in subjects with newly diagnosed GBM
II To obtain a preliminary estimate of the efficacy of DMF when combined with standard concurrent temozolomide and RT in subjects with newly diagnosed GBM
OUTLINE This is a dose-escalation study of dimethyl fumarate
CONCOMITANT THERAPY Between 21 days 3 weeks and 42 days 6 weeks following the last surgical procedure patients receive temozolomide orally PO once daily QD for 42-49 days and dimethyl fumarate PO twice daily BID or thrice daily TID continuously Patients also undergo radiation therapy 5 days a week over 6 weeks for a total of 30 fractions
MAINTENANCE THERAPY Patients continue to receive dimethyl fumarate PO BID or TID continuously Four weeks after completing concomitant temozolomide and radiation therapy patients also receive temozolomide PO QD on days 1-5 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up for 30 days and then every 2 months thereafter
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2014-02619 | REGISTRY | None | None |
| HM20003022 | None | None | None |
| MCC-13-09950 | OTHER | None | None |
| P30CA016059 | NIH | Virginia Commonwealth UniversityMassey Cancer Center | httpsreporternihgovquickSearchP30CA016059 |