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G207 Followed by Radiation Therapy in Malignant Glioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00157703
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : December 16, 2008
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
MediGene

Tracking Information
First Submitted Date  ICMJE September 8, 2005
First Posted Date  ICMJE September 12, 2005
Last Update Posted Date December 16, 2008
Study Start Date  ICMJE May 2005
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2008)
Adverse events [ Time Frame: from 1st dose to end of study visit ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
Safety and tolerability (adverse events, laboratory tests)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2005)
  • Radiographic response
  • Performance scale
  • Overall survival
  • Immune response
  • Presence of G207 in blood and saliva
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE G207 Followed by Radiation Therapy in Malignant Glioma
Official Title  ICMJE A Staged Phase 1 Study of the Treatment of Malignant Glioma With G207, a Genetically Engineered HSV-1, Followed by Radiation Therapy
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/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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Glioma
Intervention  ICMJE Drug: G207
1 x 10E9 plaque forming units, administered by stereotactic injections into the tumor (single administration)
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2008)
9
Original Enrollment  ICMJE
 (submitted: September 8, 2005)
18
Actual Study Completion Date  ICMJE December 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00157703
Other Study ID Numbers  ICMJE CT2001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alice Chen, MediGene
Study Sponsor  ICMJE MediGene
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Director: Axel Mescheder, M.D. Medigene AG
PRS Account MediGene
Verification Date December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP