Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2025-12-25 @ 4:43 PM
Study NCT ID:
NCT00157703
Status:
COMPLETED
Last Update Posted:
2008-12-16
First Post:
2005-09-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
G207 Followed by Radiation Therapy in Malignant Glioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D018316', 'term': 'Gliosarcoma'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-12', 'studyFirstSubmitDate': '2005-09-08', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2008-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'from 1st dose to end of study visit'}], 'secondaryOutcomes': [{'measure': 'Radiographic response', 'timeFrame': 'Withdrawal or death of last patient'}, {'measure': 'Performance scale', 'timeFrame': 'Last patient out'}, {'measure': 'Overall survival', 'timeFrame': 'Withdrawal or death of last patient'}, {'measure': 'Immune response', 'timeFrame': 'Last patient out'}, {'measure': 'Presence of G207 in blood and saliva', 'timeFrame': 'Last patient out'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Malignant glioma', 'Glioblastoma multiforme', 'GBM', 'Gliosarcoma', 'Anaplastic astrocytoma', 'Brain cancer', 'Brain tumor', 'Glioma', 'recurrent/progressive malignant glioma'], 'conditions': ['Malignant Glioma']}, 'referencesModule': {'references': [{'pmid': '24572293', 'type': 'DERIVED', 'citation': 'Markert JM, Razdan SN, Kuo HC, Cantor A, Knoll A, Karrasch M, Nabors LB, Markiewicz M, Agee BS, Coleman JM, Lakeman AD, Palmer CA, Parker JN, Whitley RJ, Weichselbaum RR, Fiveash JB, Gillespie GY. A phase 1 trial of oncolytic HSV-1, G207, given in combination with radiation for recurrent GBM demonstrates safety and radiographic responses. Mol Ther. 2014 May;22(5):1048-55. doi: 10.1038/mt.2014.22. Epub 2014 Feb 27.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nIn 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.\n\nAll 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Pathologically proven residual/recurrent glioblastoma multiforme, gliosarcoma or anaplastic astrocytoma which is progressive despite radiotherapy or chemotherapy\n2. Failed external beam radiotherapy \\> 5,000 CGy at least 4 weeks prior to enrollment\n3. Residual/recurrent lesion must be ≥ 1.0 cm and (for Stage 2 only) ≤ 4 cm in diameter as determined by magnetic resonance imaging (MRI)\n4. Normal hematological, renal and liver function\n\n * Absolute neutrophil count \\> 1500/mm3\n * Platelets \\> 100,000/mm3\n * Prothrombin time (PT) or partial thromboplastin time (PTT) \\< 1.3 x control\n * Creatinine \\< 1.7 mg/dl\n * Total bilirubin \\< 1.5 mg/dl\n * Transaminases \\< 4 times above the upper limits of the institutional norm\n5. Karnofsky Performance Status score ≥ 70\n6. Age \\> 19 years-old\n7. Capable of giving informed consent\n8. Must be willing to practice an effective barrier method of birth control for 2 months post G207 inoculation, whether male or female\n9. Females of childbearing potential: negative pregnancy test within 24 hours prior to G207 administration\n\nExclusion Criteria:\n\n1. Surgical resection within 4 weeks of enrolment\n2. Acute infection, granulocytopenia or medical condition precluding surgery\n3. Pregnant or lactating females\n4. History of encephalitis, multiple sclerosis, or other central nervous system (CNS) infection\n5. Tumor involvement which would require ventricular, brainstem, basal ganglia, or posterior fossa inoculation or would require access through a ventricle in order to deliver treatment or tumor involving both hemispheres or with subependymal/cerebral spinal fluid (CSF) dissemination\n6. Tumor position that could, in the Investigator's opinion, pose the risk of penetration of the cerebral ventricular system during inoculation with the study drug (Note: If penetration of the ventricular system is suspected or confirmed, G207 administration must be aborted.)\n7. Tumor locations that would expose the patient to unacceptable risk with radiation therapy\n8. Prior participant in experimental viral therapy (e.g., adenovirus, retrovirus or herpesvirus protocol)\n9. Prior participant in chemotherapy, cytotoxic therapy, immunotherapy or gene therapy protocol within 6 weeks of enrolment\n10. Required steroid increase within 2 weeks prior to injection\n11. HIV seropositive\n12. Concurrent therapy with any drug active against herpes simplex virus (HSV) (acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscavir, cidofovir)\n13. Active oral or genital herpes lesion\n14. Any contraindication for undergoing MRI such as pacemakers, infusion pumps, ferromagnetic aneurysm clips, metal prostheses, etc.\n15. Radiation treatment volume of greater than 4 cm maximum diameter (Stage 2 only)"}, 'identificationModule': {'nctId': 'NCT00157703', 'briefTitle': 'G207 Followed by Radiation Therapy in Malignant Glioma', 'organization': {'class': 'INDUSTRY', 'fullName': 'MediGene'}, 'officialTitle': 'A Staged Phase 1 Study of the Treatment of Malignant Glioma With G207, a Genetically Engineered HSV-1, Followed by Radiation Therapy', 'orgStudyIdInfo': {'id': 'CT2001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'G207', 'type': 'DRUG', 'description': '1 x 10E9 plaque forming units, administered by stereotactic injections into the tumor (single administration)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-3410', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Axel Mescheder, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Medigene AG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MediGene', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Alice Chen', 'oldOrganization': 'MediGene'}}}}