G207 Followed by Radiation Therapy in Malignant Glioma
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|ClinicalTrials.gov Identifier: NCT00157703|
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : December 16, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Glioma||Drug: G207||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Staged Phase 1 Study of the Treatment of Malignant Glioma With G207, a Genetically Engineered HSV-1, Followed by Radiation Therapy|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||December 2008|
- Drug: G207
1 x 10E9 plaque forming units, administered by stereotactic injections into the tumor (single administration)
- Adverse events [ Time Frame: from 1st dose to end of study visit ]
- Radiographic response [ Time Frame: Withdrawal or death of last patient ]
- Performance scale [ Time Frame: Last patient out ]
- Overall survival [ Time Frame: Withdrawal or death of last patient ]
- Immune response [ Time Frame: Last patient out ]
- Presence of G207 in blood and saliva [ Time Frame: Last patient out ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00157703
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294-3410|
|Study Director:||Axel Mescheder, M.D.||Medigene AG|