Solid Organ Cancers Clinical Trial
Official title:
An Open Label, Non-randomized Phase 1b Study to Investigate the Safety and Effect of the Oncolytic Virus GL-ONC1 Administered Intravenously Prior to Surgery to Patients With Solid Organ Cancers Undergoing Surgery for Curative-Intent or Palliative Resection
| Verified date | March 2020 |
| Source | University of California, San Diego |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 5 |
| Est. completion date | August 6, 2019 |
| Est. primary completion date | August 6, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | UC San Diego Moores Cancer Center | La Jolla | California |
| Lead Sponsor | Collaborator |
|---|---|
| Kaitlyn Kelly, MD | Genelux Corporation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with treatment-related adverse events as defined by CTCAE v4.03. | 2.5 years | ||
| Secondary | The presence of GL-ONC1 within malignant tumors by examination of the resected surgical specimen. | 2.5 years | ||
| Secondary | The maximum concentration (Cmax) of GL-ONC1 in blood after administration | 2.5 years | ||
| Secondary | Level of anti-vaccinia neutralizing antibodies in serum | 2.5 years | ||
| Secondary | Amount of lymphocyte infiltration in pre-treatment biopsy and post-treatment resected tumor tissue | 2.5 years |