The safety of fat-derived cells combined with a cancer-killing vaccine in patients with advanced solid tumors
- Conditions
- Advanced solid tumorsCancer
- Registration Number
- ISRCTN10201650
- Lead Sponsor
- Calidi Biotherapeutics
- Brief Summary
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31426803 (added 21/08/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 26
1. Ability to understand and the willingness to sign a written informed consent
2. Histologically proven diagnosis of advanced (AJCC, 7th addition: stage III or IV) or aggressive (published disease-specific survival rates less than 20% at 5 years following best currently available therapies) solid organ cancer
3. Have no continuing acute toxic effects of any prior therapy, including but not limited to:
3.1. Biological therapy
3.2. Radiotherapy
3.3. Chemotherapy
3.4. Surgical procedures
All such effects must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0) Grade =1. Any other
surgery (except biopsies) must have occurred at least 28 days prior to study enrollment
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
5. Have a life expectancy of at least 3 months
6. Adequate organ and marrow function
7. Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, or abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
8. Women of child-bearing potential has negative pregnancy test prior to initiating study drug dosing
9. Be willing and able to comply with scheduled visits, the treatment plan, imaging and laboratory tests
1. Current or anticipated use of other investigational agents or marketed anticancer agent while on study
2. Received chemotherapy or radiotherapy within 4 weeks prior to entering the study or has not recovered from adverse events due to agents administered more than 4 weeks earlier
3. Patients who are less than 4 weeks from surgery (except biopsies) or have insufficient recovery from surgical-related trauma or wound healing
4. Have known immune system disorders (including acquired immunodeficiency syndrome (AIDS), HIV infection or hepatitis B or C). Eligible patients must have a negative HIV test result within 4 weeks prior to study initiation
5. Receiving additional immunosuppressive therapy or any steroids (except concurrent corticosteroid usage if no more than 20 mg per day, prednisolone equivalent is applied)
6. Received prior gene therapy or therapy with cytolytic virus of any type
7. Have clinically significant cardiac disease (New York Heart Association Class III or IV) including pre-existing arrhythmia, uncontrolled angina pectoris, and myocardial infarction one year prior to study entry, or Grade 2 or higher compromised left ventricular ejection fraction
8. Pulse oximetry oxygen saturation <90% at rest
9. Dementia or altered mental status that would prohibit informed consent
10. Severe or uncontrolled medical disorder that would, in the investigator’s opinion, impair ability to receive study treatment (i.e. ncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, fever, systemic and/or uncontrolled infections, psychiatric illness/social situations that would limit compliance with study requirements)
11. Be receiving concurrent antiviral agent active against vaccinia virus (e.g., cidofovir, vaccinia immunoglobulin, imatinib, ST-246) during the course of study
12. Have known allergy to ovalbumin or other egg products
13. Have clinically significant dermatological disorders (e.g., eczema, psoriasis, or any unhealed skin wounds or ulcers) as assessed by the Principal Investigator during screening and during the study
14. Have a history of allergy to iodinated contrast media
15. Have an active dental infection or recent dental work within 2 weeks of deployment
16. Known brain metastases
17. Pregnant or nursing
18. Condition does not seem to be one that can be improved with SVF/ACAM2000 as determined by one or more of our physician team
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Safety of autologous adipose-derived stromal vascular fraction (SVF) combined with oncolytic vaccinia virus ACAM2000 in patients with advanced solid tumors, assessed using:<br> 1. Patient interviews, weekly throughout the study period<br> 2. Physical examinations at 1 day, 1 month, and 3, 6 and 12 months after treatment<br>
- Secondary Outcome Measures
Name Time Method <br> 1. Anti-tumor effects of the SVF/ACAM2000 administration, assessed at 3, 6 and 12 months after treatment using:<br> 1.1. Physical examination<br> 1.2. Imaging<br> 2. Anti-vaccinia and anti-tumor immune responses following administration of SVF/ACAM2000, assessed at 1 day, 1 month, and 3, 6 and 12 months after treatment using:<br> 2.1. Blood sample analysis for plasma cytokines<br> 2.2. Flow cytometry<br>