Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028158
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2001-12-17
Brief Title:
Safety and Effectiveness Study of G207 a Tumor-Killing Virus in Patients With Recurrent Brain Cancer
Sponsor:
MediGene
Organization:
MediGene
Study Overview
Official Title:
An Open-Label Phase IbII Study of the Safety Tolerability and Efficacy of G207 a Genetically Engineered Herpes Simplex Type-1 Virus Administered Intracerebrally to Patients With Recurrent Malignant Glioma
Status:
COMPLETED
Status Verified Date:
2001-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical trial will study the safety and effectiveness of an engineered herpes virus G207 administered directly into the brain of patients with recurrent brain cancer G207 has been modified from the herpes virus that causes cold sores called herpes simplex virus type 1 or HSV-1 G207 has been designed so that it should kill tumor cells but not harm normal brain cells G207 has been shown to be safe in animal testing completed to date and in previous studies in patients with brain tumors
This is a phase IbII study In the phase Ib portion of the study patients will receive G207 at a dose that is higher than tested in previous human studies Patients will initially receive 15 of the assigned dose injected directly into the brain tumor Approximately two days later as much of the tumor as possible will be surgically removed and more G207 will be injected into the brain tumor bed Patients will be monitored and medical tests will be done at specific study timepoints
The phase II portion will begin only if there are no safety concerns in the phase Ib portion The goals of the phase II portion of the study are to determine the safety of G207 and to study patient survival at six months after G207 dosing In the phase II portion of the study patients will receive a single dose of G207 at the highest dose determined to be safe in the phase Ib portion of the study The tumor will be removed and G207 will be injected into any remaining tumor tissue in the brain tumor bed Patients will be closely monitored medical tests will be performed at specific study visits and survival will be evaluated
This is a phase IbII study In the phase Ib portion of the study patients will receive G207 at a dose that is higher than tested in previous human studies Patients will initially receive 15 of the assigned dose injected directly into the brain tumor Approximately two days later as much of the tumor as possible will be surgically removed and more G207 will be injected into the brain tumor bed Patients will be monitored and medical tests will be done at specific study timepoints
The phase II portion will begin only if there are no safety concerns in the phase Ib portion The goals of the phase II portion of the study are to determine the safety of G207 and to study patient survival at six months after G207 dosing In the phase II portion of the study patients will receive a single dose of G207 at the highest dose determined to be safe in the phase Ib portion of the study The tumor will be removed and G207 will be injected into any remaining tumor tissue in the brain tumor bed Patients will be closely monitored medical tests will be performed at specific study visits and survival will be evaluated
Detailed Description:
Protocol NG1-003 is an open-label phase IbII study of the safety and efficacy of G207 a genetically engineered herpes simplex type-1 virus Up to 21 patients will be enrolled in the phase Ib portion and will receive doses of G207 that are higher than tested in the previous trials The highest G207 dose tested in a previous phase I trial NG1-001 was 3E9 plaque forming units pfu G207 was generally well tolerated and safe in NG1-001 and there was no dose-limiting toxicity Patients deaths were due to progressive cancer disease except for one due to radiation necrosis and two patients remain alive today
Patients in the phase Ib portion of NG1-003 will receive G207 in divided doses Initially 15 of the assigned dose will be injected into the tumor Two days later the tumor will be removed and the assigned dose of G207 will be injected into the tumor bed at the time of resection The assigned doses are as follows 1E9 3E9 and 1E10 pfu Patient status will be followed by MRI Karnofsky performance neurologic examination and the presence of G207 virus in the body in addition to other medical tests done at specific study visits
The phase II portion of protocol NG1-003 is a two-stage study The phase II portion will begin only if there are no safety concerns in the phase Ib portion The goals are to determine the safety of G207 and survival at six months Enrollment of up to 14 patients is planned for stage one Additional patients will be enrolled up to 30 additional patients and 44 overall in stage II if at least 6 of the 14 patients in stage 1 survive 6 months or longer Participants in phase II will receive a single dose of G207 at the highest dose determined to be safe from phase Ib G207 will be injected into the tumor bed at the time of resection Again patient status will be followed as previously described and survival will be evaluated
Patients in the phase Ib portion of NG1-003 will receive G207 in divided doses Initially 15 of the assigned dose will be injected into the tumor Two days later the tumor will be removed and the assigned dose of G207 will be injected into the tumor bed at the time of resection The assigned doses are as follows 1E9 3E9 and 1E10 pfu Patient status will be followed by MRI Karnofsky performance neurologic examination and the presence of G207 virus in the body in addition to other medical tests done at specific study visits
The phase II portion of protocol NG1-003 is a two-stage study The phase II portion will begin only if there are no safety concerns in the phase Ib portion The goals are to determine the safety of G207 and survival at six months Enrollment of up to 14 patients is planned for stage one Additional patients will be enrolled up to 30 additional patients and 44 overall in stage II if at least 6 of the 14 patients in stage 1 survive 6 months or longer Participants in phase II will receive a single dose of G207 at the highest dose determined to be safe from phase Ib G207 will be injected into the tumor bed at the time of resection Again patient status will be followed as previously described and survival will be evaluated
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