Solid Organ CancersPhase 1NCT02714374
GL-ONC1 Administered Intravenously Prior to Surgery to Patients With Solid Organ Cancers
A Phase 1 study testing GL-ONC1 in people with Solid Organ Cancers, run by Andrew Lowy at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Organ Cancers
- What is being tested?
- GL-ONC1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2016to 6 Aug 2019
- 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
- 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
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UC San Diego Moores Cancer Center
La Jolla, California, 92093
About this study
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
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.
Read the detailed description
This is an open-label, non-randomized Phase 1b dose escalation study evaluating the safety and effect of the oncolytic virus GL-ONC1 administered intravenously, with or without eculizumab, prior to surgery in patients with advanced solid organ tumors.
GL-ONC1 is a genetically engineered oncolytic vaccinia virus, which disrupts nonessential genes and expression of the foreign gene expression. Evidence suggest that GL-ONC1 is able to infect tumor tissue and kill tumor cells.
The goals of this study are to evaluate the safety of GL-ONC1 and to assess the pharmacokinetics and pharmacodynamics profile of GL-ONC1 in vivo.
- Conditions
- Solid Organ Cancers
- Being tested
- GL-ONC1
- 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
- Medical subject headings
- Neoplasms, Melanoma, Cholangiocarcinoma, Gallbladder Neoplasms, Colorectal Neoplasms, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GL-ONC1Biological
Dose and Regimen:
- Single dose group: Cohort 1 dose is 1 × 109 pfu
- 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.
| Study group | Role | What they receive |
|---|---|---|
| GL-ONC1 | Experimental | Cohort 3, 5, 7, 8, 9 Receives: Biological: GL-ONC1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2.5 years
Secondary outcomes (4)
The presence of GL-ONC1 within malignant tumors by examination of the resected surgical specimen.
The presence of GL-ONC1 within malignant tumors by examination of the resected
Measured: 2.5 years
The maximum concentration (Cmax) of GL-ONC1 in blood after administration
The maximum concentration (Cmax) of GL-ONC1 in blood after administration
Measured: 2.5 years
Level of anti-vaccinia neutralizing antibodies in serum
Level of anti-vaccinia neutralizing antibodies in serum
Measured: 2.5 years
Amount of lymphocyte infiltration in pre-treatment biopsy and post-treatment resected tumor tissue
Amount of lymphocyte infiltration in pre-treatment biopsy and post-treatment resected
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study start25 Mar 2016
- Primary completion6 Aug 2019
- Study completion6 Aug 2019
Why it stopped: Insufficient funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Organ CancersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Lowy
- Sponsor type
- University, hospital or other
- Collaborators
- Genelux Corporation
- Responsible party
- Sponsor-investigator, Andrew Lowy, University of California, San Diego
- Investigators
- Kaitlyn Kelly, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02714374
- Sponsor's protocol ID
- 151060
- Status last verified
- Aug 2024
- First submitted
- 2 Mar 2016
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02714374
- Acronym / sponsor ID
- 151060
- Conditions
- Solid Organ Cancers
- Keywords
- GL-ONC1, Solid Organ Cancer, Cancer, Surgery, Oncolytic Virus, Soliris, Metastatic melanoma, Esophageal and gastric adenocarcinoma (Stage III/IV)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient funding
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Andrew LowyUniversity, hospital or other
- Collaborators
- Genelux Corporation
- Study start
- 25 Mar 2016 (actual)
- Primary completion
- 6 Aug 2019 (actual)
- Study completion
- 6 Aug 2019 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open-label, non-randomized Phase 1b dose escalation study evaluating the safety and effect of the oncolytic virus GL-ONC1 administered intravenously, with or without eculizumab, prior to surgery in patients with advanced solid organ tumors.
GL-ONC1 is a genetically engineered oncolytic vaccinia virus, which disrupts nonessential genes and expression of the foreign gene expression. Evidence suggest that GL-ONC1 is able to infect tumor tissue and kill tumor cells.
The goals of this study are to evaluate the safety of GL-ONC1 and to assess the pharmacokinetics and pharmacodynamics profile of GL-ONC1 in vivo.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GL-ONC1 | Experimental | Biological: GL-ONC1Cohort 3, 5, 7, 8, 9 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GL-ONC1Dose 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. | Biological | GL-ONC1 |
Primary outcome
Number of participants with treatment-related adverse events as defined by CTCAE v4.03.
Time frame: 2.5 years
Number of participants with treatment-related adverse events as defined by CTCAE v4.03.
4 secondary outcomes
The presence of GL-ONC1 within malignant tumors by examination of the resected surgical specimen.
Time frame: 2.5 years
The maximum concentration (Cmax) of GL-ONC1 in blood after administration
Time frame: 2.5 years
Level of anti-vaccinia neutralizing antibodies in serum
Time frame: 2.5 years
Amount of lymphocyte infiltration in pre-treatment biopsy and post-treatment resected tumor tissue
Time frame: 2.5 years
Results and safety
The study was stopped early (reason given: Insufficient funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kaitlyn Kelly, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GL-ONC1 in people with Solid Organ Cancers, run by Andrew Lowy 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 9 inclusion and 12 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: stopped early, as of the sponsor's last update on 6 Aug 2024. 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 was stopped early (reason given: Insufficient funding). Results are not available in the source record.
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?
Number of participants with treatment-related adverse events as defined by CTCAE v4.03. (time frame: 2.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2024.