Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441142
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2007-02-27
Brief Title:
Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors
Sponsor:
Patrick Y Wen MD
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase III Study of ZD6474 Vandetanib With Radiation Therapy and Concomitant and Adjuvant Temozolomide in Patients With Newly-Diagnosed Glioblastoma
Status:
COMPLETED
Status Verified Date:
2019-02
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:
Zactima
Brief Summary:
Phase I
The purpose of this research study is to determine the safety of the combination treatment of ZD6474 Vandetanib with the standard therapy for glioblastomas and gliosarcomas temozolomide Temodar and radiation therapy This agent is investigational for the treatment of glioblastomas We will determine the highest dose of ZD6474 Vandetanib that can be given safely when combined with temozolomide Temodar and radiation therapy
Phase II
The purpose of this research study is to determine the efficacy of the combination treatment of ZD6474 Vandetanib with the standard therapy for glioblastomas and gliosarcomas temozolomide Temodar and radiation therapy This agent is investigational for the treatment of glioblastomas
All subjects participating in this research study must NOT be taking a certain type of anti-seizure medication called enzyme inducing anticonvulsant drugs These drugs include but are not limited to the following medications Dilantin Tegretol Phenobarbital and trileptal
The purpose of this research study is to determine the safety of the combination treatment of ZD6474 Vandetanib with the standard therapy for glioblastomas and gliosarcomas temozolomide Temodar and radiation therapy This agent is investigational for the treatment of glioblastomas We will determine the highest dose of ZD6474 Vandetanib that can be given safely when combined with temozolomide Temodar and radiation therapy
Phase II
The purpose of this research study is to determine the efficacy of the combination treatment of ZD6474 Vandetanib with the standard therapy for glioblastomas and gliosarcomas temozolomide Temodar and radiation therapy This agent is investigational for the treatment of glioblastomas
All subjects participating in this research study must NOT be taking a certain type of anti-seizure medication called enzyme inducing anticonvulsant drugs These drugs include but are not limited to the following medications Dilantin Tegretol Phenobarbital and trileptal
Detailed Description:
Currently the standard treatment for glioblastomas and gliosarcomas is temozolomide Temodar and radiation therapy This study is being done because research has shown that glioblastomas have genetic changes that may cause an excess of certain cell growth factors and their receptors which can cause uncontrolled tumor growth The drug being used in this research study ZD6474 Vandetanib is designed to block the receptors to two of these growth factors the vascular endothelial growth factor VEGF and the epidermal growth factor EGF These growth factors are important in pathways that promote tumor growth and increasing blood supply to the tumor Blocking these receptors may reduce the blood supply to the tumor and help slow down tumor growth There is also laboratory evidence that blocking these receptors may increase the sensitivity of glioblastomas to radiation therapy
This research study is a Phase III clinical trial
Phase I clinical trials test the safety of an investigational drug Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies We will determine the highest dose of ZD6474 Vandetanib that can be given safely when combined with temozolomide Temodar and radiation therapy
The purpose of Phase II of this research study is to determine the efficacy of the combination treatment of ZD6474 Vandetanib with the standard therapy for glioblastomas and gliosarcomas temozolomide Temodar and radiation therapy It will look to see how patients fare on treatment if they progress and when how they are doing after 12 months of treatment In this research study the safety of the combination treatment of ZD6474 Vandetanib with the standard therapy for glioblastomas and gliosarcomas temozolomide Temodar and radiation therapy will be further evaluated We will also be looking at samples to see if there are correlations between them and how well patients do on treatment
This agent is investigational for the treatment of glioblastomas Investigational means that the drug is still being studied and that research doctors are trying to find out more about it It also means that the FDA US Food and Drug Administration has not approved ZD6474 Vandetanib for use for your type of cancer All subjects participating in this research study must NOT be taking a certain type of anti-seizure medication called enzyme inducing anticonvulsant drugs These drugs include the following medications Dilantin Tegretol Phenobarbital and trileptal
This research study is a Phase III clinical trial
Phase I clinical trials test the safety of an investigational drug Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies We will determine the highest dose of ZD6474 Vandetanib that can be given safely when combined with temozolomide Temodar and radiation therapy
The purpose of Phase II of this research study is to determine the efficacy of the combination treatment of ZD6474 Vandetanib with the standard therapy for glioblastomas and gliosarcomas temozolomide Temodar and radiation therapy It will look to see how patients fare on treatment if they progress and when how they are doing after 12 months of treatment In this research study the safety of the combination treatment of ZD6474 Vandetanib with the standard therapy for glioblastomas and gliosarcomas temozolomide Temodar and radiation therapy will be further evaluated We will also be looking at samples to see if there are correlations between them and how well patients do on treatment
This agent is investigational for the treatment of glioblastomas Investigational means that the drug is still being studied and that research doctors are trying to find out more about it It also means that the FDA US Food and Drug Administration has not approved ZD6474 Vandetanib for use for your type of cancer All subjects participating in this research study must NOT be taking a certain type of anti-seizure medication called enzyme inducing anticonvulsant drugs These drugs include the following medications Dilantin Tegretol Phenobarbital and trileptal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| IRUSZACT0018 | OTHER | AstraZeneca | None |