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
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.
Main
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
United States: Food and Drug Administration
NG1-003
NCT00028158
December 2001
October 2003
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