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G207 Followed by Radiation Therapy in Malignant Glioma

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 19 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Pathologically proven residual/recurrent glioblastoma multiforme, gliosarcoma or anaplastic astrocytoma which is progressive despite radiotherapy or chemotherapy. 2. Failed external beam radiotherapy > 5,000 CGy at least 4 weeks prior to enrollment. 3. Residual/recurrent lesion must be ≥ 1.0 cm and (for Stage 2 only) ≤ 4 cm in diameter as determined by magnetic resonance imaging (MRI) 4. Normal hematological, renal and liver function.
  • - Absolute neutrophil count > 1500/mm3.
  • - Platelets > 100,000/mm3.
  • - Prothrombin time (PT) or partial thromboplastin time (PTT) < 1.3 x control.
  • - Creatinine < 1.7 mg/dl.
  • - Total bilirubin < 1.5 mg/dl.
  • - Transaminases < 4 times above the upper limits of the institutional norm.
5. Karnofsky Performance Status score ≥ 70. 6. Age > 19 years-old. 7. Capable of giving informed consent. 8. Must be willing to practice an effective barrier method of birth control for 2 months post G207 inoculation, whether male or female. 9. Females of childbearing potential: negative pregnancy test within 24 hours prior to G207 administration.

Exclusion Criteria:

1. Surgical resection within 4 weeks of enrolment. 2. Acute infection, granulocytopenia or medical condition precluding surgery. 3. Pregnant or lactating females. 4. History of encephalitis, multiple sclerosis, or other central nervous system (CNS) infection. 5. 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. 6. 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.) 7. Tumor locations that would expose the patient to unacceptable risk with radiation therapy. 8. Prior participant in experimental viral therapy (e.g., adenovirus, retrovirus or herpesvirus protocol) 9. Prior participant in chemotherapy, cytotoxic therapy, immunotherapy or gene therapy protocol within 6 weeks of enrolment. 10. Required steroid increase within 2 weeks prior to injection. 11. HIV seropositive. 12. Concurrent therapy with any drug active against herpes simplex virus (HSV) (acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscavir, cidofovir) 13. Active oral or genital herpes lesion. 14. Any contraindication for undergoing MRI such as pacemakers, infusion pumps, ferromagnetic aneurysm clips, metal prostheses, etc. 15. Radiation treatment volume of greater than 4 cm maximum diameter (Stage 2 only)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT00157703
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

MediGene
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Axel Mescheder, M.D.
Principal Investigator Affiliation Medigene AG
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Malignant Glioma

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3410