Glioblastoma Clinical Trial
Official title:
An Open-Label Phase Ib/II 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
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 Ib/II 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.
Protocol NG1-003 is an open-label, phase Ib/II 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.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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