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Cancer of Head and NeckPhase 1NCT01584284

Safety Study of Attenuated Vaccinia Virus (GL-ONC1)With Combination Therapy in Head & Neck Cancer

A Phase 1 study testing GL-ONC1 in people with Cancer of Head and Neck, run by Genelux Corporation 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

The purpose of this study is to determine the safety and tolerability of GL-ONC1 administered intravenously in combination with radiation therapy and cisplatin (CDDP)in patients with locoregionally advanced head and neck cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer of Head and Neck
What is being tested?
GL-ONC1
How many people
19 participants
Where
1 siteUnited States
Study dates
Apr 2012to Jul 2015
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed diagnosis of histologically or cytologically documented Stage III to IVB primary, non-metastatic head and neck cancer for newly diagnosed patients with no prior disease-related treatment (e.g., chemotherapy, radiation treatment, surgery, etc.).
  • American Joint Committee on Cancer (AJCC) Stage III-IVB disease (2010 manual, 7th edition), based on standard diagnostic workup.
  • 18 years or older.
  • ECOG performance status of ≤ 2.
  • Laboratory data obtained within 14 days prior to Treatment Day 1, with adequate hepatic and renal function defined as follows:
  • Absolute neutrophil count (ANC) ≥ 1,800 cells/mm3;
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  • Platelets ≥ 100,000 cells/mm3;
  • Hemoglobin ≥ 8.0 g/dL;
  • Bilirubin ≤ 1.5 mg/dL;
  • AST or ALT ≤ 2× upper limit of normal (ULN);
  • Serum creatinine ≤ 1.5 mg/dL;
  • Creatinine clearance (CC) ≥ 50 mL/min.
  • Pulse oximetry reading of 92% or higher at rest on room air.
  • Signed informed consent
  • Women of childbearing potential must have a negative serum pregnancy test and agree to practice effective birth control during treatment phase and up to 60 days after the last virus application.
  • Male patients must agree to practice effective birth control during the study and for 60 days following administration of last treatment of virus.

Who cannot join

  • Clinical, radiographic, or pathologic evidence of distant metastatic disease.
  • Patients with fever, active immunosuppressive systemic infection or a suppressed immune system, including AIDS or HIV positivity and known hepatitis infections (HCV or HBC. Eligible patients must have an HIV test conducted within 4 weeks prior to study enrollment with a negative test result.
  • Any form of prior anti-cancer treatment.
  • Disease-related surgery, excluding biopsy.
  • Patients with CNS (Central Nervous System) tumors.
  • Any other open wounds.
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  • Concurrent small pox vaccination for 4 weeks before study therapy and during study treatment.
  • Patients on immunosuppressive therapy or with immune system disorders, including autoimmune diseases.
  • Prior splenectomy.
  • Previous organ transplantation.
  • Patients with clinically significant dermatological disorders, as judged by the clinical investigator (e.g., eczema or psoriasis), any skin lesions or ulcers, any history of atopic dermatitis, or any history of Darier's disease (Keratosis Follicularis).
  • Clinically significant cardiac disease (New York Heart Association: Class III or IV).
  • Dementia or altered mental status that would prohibit informed consent.
  • Known allergy to ovalbumin or egg products.
  • Prior gene therapy treatments or prior therapy with cytolytic virus of any type.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Moores UC San Diego Cancer Center

    La Jolla, California, 92037

Other trials in United States

About this study

Official title: Phase I Trial Of Attenuated Vaccinia Virus (GL-ONC1) Delivered Intravenously With Concurrent Cisplatin and Radiotherapy in Patients With Locoregionally Advanced Head and Neck Carcinoma

The purpose of this study is to determine the safety and tolerability of GL-ONC1 administered intravenously in combination with radiation therapy and cisplatin (CDDP)in patients with locoregionally advanced head and neck cancer.

Read the detailed description

GL-ONC1, an oncolytic vaccinia virus, has shown the ability to preferentially locate, colonize and destroy tumor cells in more than 40 different human tumors. A First-in-Man, Phase I clinical study focusing on the safety and tolerability of GL-ONC1 intravenously administered to patients with a variety of advanced solid tumor entities has shown that GL-ONC1 is well-tolerated at therapeutic dose levels, with documented evidence of antitumor activity. Preclinical studies have further shown synergistic effects with the use of chemotherapy (Cisplatin) and viral therapy with GL-ONC, as well as favorable results when cancer cells are irradiated and then treated with GL-ONC1 in animal models. This Phase I study seeks to evaluate the safety, tolerability and early signs of efficacy of GL-ONC1 administered intravenously in combination with standard of care (SOC) radiation therapy (RT) and cisplatin (CDDP)in patients with locoregionally advanced head and neck cancer. Patients will be individually assessed for safety and dose limiting toxicity. Viral colonization in tumors, replication and anti-tumoral activity will also be evaluated.

Being tested
GL-ONC1
Keywords
Genelux, Genelux Corporation, GL-ONC1, Vaccinia, Vaccinia Virus, Oncolytic virus, Oncolytic Virotherapy, Head and Neck Cancer, Squamous Cell Carcinoma
Medical subject headings
Head and Neck Neoplasms, Vaccinia, Carcinoma, Squamous Cell

What participants receive

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

  • GL-ONC1Biological

    A genetically-engineered vaccinia virus administered via intravenous infusion . Cohorts 1, 2, 3: Frequency: 1x in Week 1; Cohort 4: 1x again 1x in Week 2; Cohort 5: 1x Week 1, 1x Week 2, 1x Week 3, 1x Week 4.

What is being measured

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

  1. Safety and Tolerability as measured by the number of patients with Adverse Events, as well as type of AE and frequency

    Evaluation of changes in laboratory tests (hematological, chemistry), immunogenicity and physical examination

    Measured: Baseline up to week 23 Post-treatment

Secondary outcomes (3)

  1. Presence of Virus in Tumor

    Analysis of tumor tissue (obtained through surgical or core biopsy if accessible from consenting patients) following viral treatment.

    Measured: At baseline (Within 4 weeks of Treatment Day 1); 9-13 days post viral injection

  2. Determine Initial Susceptibility of tumor to viral infection

    Evaluate susceptibility of initial biopsied tumor to viral infection in cell cultures (for patients consenting to biopsy and where tumor is accessible).

    Measured: At baseline (Within 4 weeks of Treatment Day 1)

  3. Anti-Tumor Activity (Early Efficacy)

    Assessing changes in tumor measurement through physical examination, CT or CT/PET scan

    Measured: Change from baseline up to week 23 Post-treatment (week 23)

Timeline

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

  1. First posted24 Apr 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionJun 2015
  4. Study completionJul 2015

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01584284
Sponsor's protocol ID
GL-ONC1-005
Status last verified
Aug 2015
First submitted
22 Apr 2012
Last updated
25 Aug 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GL-ONC1 in people with Cancer of Head and Neck, run by Genelux Corporation 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 16 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 25 Aug 2015. 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?

Safety and Tolerability as measured by the number of patients with Adverse Events, as well as type of AE and frequency (time frame: Baseline up to week 23 Post-treatment). 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 NCT01584284.

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 25 Aug 2015.

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