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

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. Identifier: NCT01584284
Recruitment Status : Completed
First Posted : April 24, 2012
Last Update Posted : August 25, 2015
Information provided by (Responsible Party):
Genelux Corporation

Tracking Information
First Submitted Date  ICMJE April 22, 2012
First Posted Date  ICMJE April 24, 2012
Last Update Posted Date August 25, 2015
Study Start Date  ICMJE April 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2012)
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 ]
Evaluation of changes in laboratory tests (hematological, chemistry), immunogenicity and physical examination
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2012)
  • Presence of Virus in Tumor [ Time Frame: At baseline (Within 4 weeks of Treatment Day 1); 9-13 days post viral injection ]
    Analysis of tumor tissue (obtained through surgical or core biopsy if accessible from consenting patients) following viral treatment.
  • Determine Initial Susceptibility of tumor to viral infection [ Time Frame: At baseline (Within 4 weeks of Treatment Day 1) ]
    Evaluate susceptibility of initial biopsied tumor to viral infection in cell cultures (for patients consenting to biopsy and where tumor is accessible).
  • Anti-Tumor Activity (Early Efficacy) [ Time Frame: Change from baseline up to week 23 Post-treatment (week 23) ]
    Assessing changes in tumor measurement through physical examination, CT or CT/PET scan
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Safety Study of Attenuated Vaccinia Virus (GL-ONC1)With Combination Therapy in Head & Neck Cancer
Official Title  ICMJE 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
Brief 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cancer of Head and Neck
Intervention  ICMJE Biological: GL-ONC1
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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 21, 2015)
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2012)
Actual Study Completion Date  ICMJE July 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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;
    • 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.

Exclusion Criteria:

  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 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 NCT01584284
Other Study ID Numbers  ICMJE GL-ONC1-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genelux Corporation
Study Sponsor  ICMJE Genelux Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Loren K Mell, MD Moores UC San Diego Cancer Center
PRS Account Genelux Corporation
Verification Date August 2015

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