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

NCT01584284 | Completed Phase 1 DMC

• 1 other identifier: GL-ONC1-005
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer of Head and Neck

Keywords

Genelux; Genelux Corporation; GL-ONC1; Vaccinia; Vaccinia Virus; Oncolytic virus; Oncolytic Virotherapy; Head and Neck Cancer; Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (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

  Baseline up to week 23 Post-treatment

Secondary Outcomes (3)

• Presence of Virus in Tumor

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

• Determine Initial Susceptibility of tumor to viral infection

  At baseline (Within 4 weeks of Treatment Day 1)

• Anti-Tumor Activity (Early Efficacy)

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

Interventions

GL-ONC1 BIOLOGICAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Genelux Corporation: lead

Study Sites (1)

Moores UC San Diego Cancer Center

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Vaccinia; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Poxviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Study Officials

• Loren K Mell, MD

  Moores UC San Diego Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2012
• First Posted: April 24, 2012
• Study Start: April 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: August 25, 2015

Record last verified: 2015-08

Locations

US (1)