Status:
COMPLETED
G207 Followed by Radiation Therapy in Malignant Glioma
Lead Sponsor:
MediGene
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Malignant Glioma
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
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/progress...
Eligibility Criteria
Inclusion
- Pathologically proven residual/recurrent glioblastoma multiforme, gliosarcoma or anaplastic astrocytoma which is progressive despite radiotherapy or chemotherapy
- Failed external beam radiotherapy \> 5,000 CGy at least 4 weeks prior to enrollment
- Residual/recurrent lesion must be ≥ 1.0 cm and (for Stage 2 only) ≤ 4 cm in diameter as determined by magnetic resonance imaging (MRI)
- 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
- Karnofsky Performance Status score ≥ 70
- Age \> 19 years-old
- Capable of giving informed consent
- Must be willing to practice an effective barrier method of birth control for 2 months post G207 inoculation, whether male or female
- Females of childbearing potential: negative pregnancy test within 24 hours prior to G207 administration
Exclusion
- Surgical resection within 4 weeks of enrolment
- Acute infection, granulocytopenia or medical condition precluding surgery
- Pregnant or lactating females
- History of encephalitis, multiple sclerosis, or other central nervous system (CNS) infection
- 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
- 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.)
- Tumor locations that would expose the patient to unacceptable risk with radiation therapy
- Prior participant in experimental viral therapy (e.g., adenovirus, retrovirus or herpesvirus protocol)
- Prior participant in chemotherapy, cytotoxic therapy, immunotherapy or gene therapy protocol within 6 weeks of enrolment
- Required steroid increase within 2 weeks prior to injection
- HIV seropositive
- Concurrent therapy with any drug active against herpes simplex virus (HSV) (acyclovir, valaciclovir, penciclovir, famciclovir, ganciclovir, foscavir, cidofovir)
- Active oral or genital herpes lesion
- Any contraindication for undergoing MRI such as pacemakers, infusion pumps, ferromagnetic aneurysm clips, metal prostheses, etc.
- Radiation treatment volume of greater than 4 cm maximum diameter (Stage 2 only)
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00157703
Start Date
May 1 2005
End Date
December 1 2008
Last Update
December 16 2008
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3410