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Malignant GliomaPhase 1NCT00157703

G207 Followed by Radiation Therapy in Malignant Glioma

A Phase 1 study testing G207 in people with Malignant Glioma, run by MediGene at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Malignant Glioma
What is being tested?
G207
Type of treatment
Injection or infusion
How many people
9 participants
Where
1 siteUnited States
Study dates
May 2005to Dec 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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.)
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  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-3410

Other trials in United States

About this 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

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.

Read more

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.

Being tested
G207
Keywords
Malignant glioma, Glioblastoma multiforme, GBM, Gliosarcoma, Anaplastic astrocytoma, Brain cancer, Brain tumor, Glioma, recurrent/progressive malignant glioma
Medical subject headings
Glioma, Glioblastoma, Gliosarcoma, Astrocytoma, Brain Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • G207Drug

    1 x 10E9 plaque forming units, administered by stereotactic injections into the tumor (single administration)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

    Measured: from 1st dose to end of study visit

Secondary outcomes (5)

  1. Radiographic response

    Measured: Withdrawal or death of last patient

  2. Performance scale

    Measured: Last patient out

  3. Overall survival

    Measured: Withdrawal or death of last patient

  4. Immune response

    Measured: Last patient out

  5. Presence of G207 in blood and saliva

    Measured: Last patient out

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionOct 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00157703
Sponsor's protocol ID
CT2001
Status last verified
Dec 2008
First submitted
8 Sep 2005
Last updated
16 Dec 2008
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 24572293

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing G207 in people with Malignant Glioma, run by MediGene at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: from 1st dose to end of study visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00157703, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2008.

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