G207 Followed by Radiation Therapy in Malignant Glioma
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Staged Phase 1 Study of the Treatment of Malignant Glioma With G207, a Genetically Engineered HSV-1, Followed by Radiation Therapy|
- Adverse events [ Time Frame: from 1st dose to end of study visit ] [ Designated as safety issue: Yes ]
- Radiographic response [ Time Frame: Withdrawal or death of last patient ] [ Designated as safety issue: No ]
- Performance scale [ Time Frame: Last patient out ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: Withdrawal or death of last patient ] [ Designated as safety issue: No ]
- Immune response [ Time Frame: Last patient out ] [ Designated as safety issue: No ]
- Presence of G207 in blood and saliva [ Time Frame: Last patient out ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2005|
|Study Completion Date:||December 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294-3410|
|Study Director:||Axel Mescheder, M.D.||MediGene AG|