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Sponsors and Collaborators: |
MediGene National Cancer Institute (NCI) |
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Information provided by: | MediGene |
ClinicalTrials.gov Identifier: | NCT00157703 |
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 | Intervention | Phase |
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Malignant Glioma |
Drug: G207 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Staged Phase 1 Study of the Treatment of Malignant Glioma With G207, a Genetically Engineered HSV-1, Followed by Radiation Therapy |
Enrollment: | 9 |
Study Start Date: | May 2005 |
Study Completion Date: | December 2008 |
Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 19 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Normal hematological, renal and liver function
Exclusion Criteria:
Responsible Party: | MediGene ( Alice Chen ) |
Study ID Numbers: | CT2001 |
Study First Received: | September 8, 2005 |
Last Updated: | December 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00157703 |
Health Authority: | United States: Food and Drug Administration |
Malignant glioma Glioblastoma multiforme GBM Gliosarcoma Anaplastic astrocytoma |
Brain cancer Brain tumor Glioma recurrent/progressive malignant glioma |
Neuroectodermal Tumors Brain Neoplasms Glioblastoma Glioblastoma multiforme Astrocytoma Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Glioma Gliosarcoma Recurrence Neoplasms, Glandular and Epithelial |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |