NCT00157703

G207 Followed by Radiation Therapy in Malignant Glioma

A Staged Phase 1 Study of the Treatment of Malignant Glioma With G207, a Genetically Engineered HSV-1, Followed by Radiation Therapy

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: MediGene · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single site study to evaluate the safety and tolerability of intratumoral administration of G207 followed by treatment with radiation therapy in patients with recurrent/progressive malignant glioma. This study is a two stage phase 1 study, in which a de-escalating dosing scheme will be used, i.e. the first patients will receive the higher dose and if excessive toxicity occurs, the dose will be reduced for the following patients. The purpose of the dose de-escalation phase is to find the best safe dose of G207. In the first stage of the study, treatment with G207 will be followed by focal radiation therapy on the following day, and in the second stage treatment with G207 will be followed by gamma knife surgery also on the following day. All patients will return to the clinic 28 days and 3, 6, 9 and 12 months after G207 administration at which time clinical assessments will be performed, and will be followed for safety and survival at clinic visits or by telephone every 3 months for up to 2 additional years and annually thereafter.

Conditions

• Malignant Glioma

Interventions

Type	Name	Description
DRUG	G207	1 x 10E9 plaque forming units, administered by stereotactic injections into the tumor (single administration)

Timeline

• Start date: 2005-05-01
• Primary completion: 2008-10-01
• Completion: 2008-12-01
• First posted: 2005-09-12
• Last updated: 2008-12-16

Locations

1 site across 1 country: United States