GL-ONC1 Administered Intravenously Prior to Surgery to Patients With Solid Organ Cancers

NCT02714374 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: 151060
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety of the investigational product GL-ONC1. GL-ONC1, a vaccinia virus, has been genetically modified for use as a potential anti-cancer drug to destroy cancer cells. Vaccinia virus has been used successfully in the past as smallpox vaccine in millions of people worldwide.

Conditions

Solid Organ Cancers

Keywords

GL-ONC1; Solid Organ Cancer; Cancer; Surgery; Oncolytic Virus; Soliris; Metastatic melanoma; Esophageal and gastric adenocarcinoma (Stage III/IV); Cholangiocarcinoma; Pancreatic adenocarcinoma; Gallbladder cancer; Colorectal cancer (Stage IV); High-grade mucinous appendix cancer; High-grade gastrointestinal neuroendocrine cancer; Mesothelioma; High-grade soft tissue sarcoma; Stage III or IV

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as defined by CTCAE v4.03.

  Number of participants with treatment-related adverse events as defined by CTCAE v4.03.

  2.5 years

Secondary Outcomes (4)

• The presence of GL-ONC1 within malignant tumors by examination of the resected surgical specimen.

  2.5 years

• The maximum concentration (Cmax) of GL-ONC1 in blood after administration

  2.5 years

• Level of anti-vaccinia neutralizing antibodies in serum

  2.5 years

• Amount of lymphocyte infiltration in pre-treatment biopsy and post-treatment resected tumor tissue

  2.5 years

Study Arms (1)

GL-ONC1

EXPERIMENTAL

Cohort 3, 5, 7, 8, 9

Biological: GL-ONC1

Interventions

GL-ONC1 BIOLOGICAL

Dose and Regimen: 1. Single dose group: Cohort 1 dose is 1 × 109 pfu 2. Multiple dose groups: * Cohort 2 dose is 1 × 109 pfu × 5 consecutive days * Cohorts 3 and 4 dose is 2 × 109 pfu × 5 consecutive days * Cohorts 5 and 6 dose escalates at 2,3,5,5,5 × 109 pfu. Route: GL-ONC1 is delivered as a bolus IV injection.

GL-ONC1

Eligibility Criteria

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

You may qualify if:

• Histologically-proven diagnosis of advanced (AJCC, 7th Edition: stage III or IV) or aggressive solid organ cancer.
• Patients must provide written consent for a core needle biopsy sample of tumor tissue (primary or metastatic).
• Have evidence of measurable disease (according to RECIST Version 1.1: http:// www.recist.com).
• Have an ECOG Performance Score of 0 to 2.
• Have a life expectancy of at least 3 months.
• Have adequate organ and marrow function
• Negative serum pregnancy test for females of childbearing potential.
• Have negative test result for HIV and Hepatitis B or C testing.
• Have baseline anti-vaccinia antibody titer \< 10.

You may not qualify if:

• Current or anticipated use of other investigational agents or marketed anticancer agent while on study (from the time of enrollment through the time of surgery).
• Patients who have received chemotherapy or radiotherapy within 4 weeks prior to entering the study.
• Small pox vaccination for 4 weeks before study therapy and during study treatment.
• Have received prior gene therapy or therapy with cytolytic virus of any type.
• Have clinically significant cardiac disease
• Oxygen saturation \<90% measured by pulse oximetry at rest.
• Receiving concurrent antiviral agent active against vaccinia virus (e.g., cidofovir, vaccinia immunoglobulin, imatinib, ST-246) during the course of study.
• Have known allergy to ovalbumin or other egg products.
• Have clinically significant dermatological disorders (e.g., eczema, psoriasis, or any unhealed skin wounds or ulcers)
• Have a history of allergy to iodinated contrast media.
• Patients with known brain metastases
• Pregnant or nursing

Sponsors & Collaborators

• Andrew Lowy: lead
• Genelux Corporation: collaborator

Study Sites (1)

UC San Diego Moores Cancer Center

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Neoplasms; Melanoma; Cholangiocarcinoma; Gallbladder Neoplasms; Colorectal Neoplasms; Mesothelioma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Biliary Tract Neoplasms; Digestive System Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenoma; Neoplasms, Mesothelial

Study Officials

• Kaitlyn Kelly, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Division of Surgical Oncology

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 21, 2016
• Study Start: March 25, 2016
• Primary Completion: August 6, 2019
• Study Completion: August 6, 2019
• Last Updated: August 6, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)