Study on OST31-164 Maintenance Therapy for Osteosarcoma Patients
Sponsor: Emerald Clinical Inc.
ClinicalTrials ID:NCT04974008
This clinical trial is testing a new treatment called OST31-164 for patients aged 12 to 39 who have had osteosarcoma (a type of bone cancer) that returned in the lungs and was recently removed by surgery. Participants will receive the treatment every three weeks for about a year and will be monitored for three years afterward.
Patient Parameters
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Program Overview
The study aims to evaluate the effectiveness of OST31-164 in preventing the return of osteosarcoma in patients whose lung tumors have been surgically removed. Up to 45 patients will participate, receiving the treatment every three weeks for 48 weeks. After completing the treatment, patients will be followed for three years to monitor their health and any recurrence of cancer. The study will also explore how the immune system responds to the treatment, and tissue samples from surgery may be analyzed for further research.
Description
This clinical trial is designed for patients aged 12 to 39 who have had osteosarcoma that returned in the lungs and was completely removed by surgery. The study will enroll up to 45 participants who will receive the OST31-164 treatment every three weeks for a total of 48 weeks. Each treatment cycle lasts 12 weeks, and patients will receive four doses per cycle. The treatment will continue unless the cancer progresses, side effects become too severe, or other criteria for stopping treatment are met. After the treatment phase, participants will enter a three-year follow-up period to track their survival and health outcomes. The study will also look at how the immune system reacts to the treatment, and if available, tissue samples from the surgery will be sent for further analysis. Participants must meet specific health criteria to join the study, including adequate organ function and recovery from previous cancer treatments. Both male and female participants must agree to use effective birth control during the study and for a period afterward to prevent pregnancy.
Eligibility Criteria
Inclusion Criteria
- Aged between 12 and 39 years old.
- Weigh at least 40 kg.
- Diagnosed with osteosarcoma and have had at least one recurrence in the lungs.
- All lung tumors must have been surgically removed within 8 weeks before joining the study.
- Must have a good performance status, meaning they can carry out daily activities with little or no assistance.
- Must have recovered from any previous cancer treatments.
- Must have adequate organ function, including healthy blood counts, kidney, liver, heart, and lung function.
- Must not have any active infections or require ongoing antibiotic treatment.
- Must be able to understand the study and provide informed consent, with parental or guardian consent if underage.
- Female participants must not be pregnant or breastfeeding and must agree to use birth control during the study and for 120 days after the last treatment.
- Male participants must agree to use birth control during the study and for 120 days after the last treatment.
Exclusion Criteria
- Have visible signs of cancer spread or recurrence.
- Have cancer that has returned in both the lungs and the original tumor site.
- Have cancer that did not respond to initial treatment.
- Have cancer that has spread to the brain or other areas outside the lungs.
- Have an active infection requiring treatment or are on antibiotics that cannot be stopped before treatment.
- Are currently using or have recently used corticosteroids.
- Are participating in another clinical trial or using an investigational device.
- Have had another active cancer within the last 2 years, except for certain skin cancers or cervical cancer.
- Have an autoimmune disease requiring treatment in the past 3 months.
- Have psychiatric or substance abuse issues that would interfere with the study.
- Are pregnant or breastfeeding.
- Have allergies to the study treatment components.
- Are currently receiving chemotherapy or have had certain treatments recently.
- Have a history of listeriosis or certain viral infections.
- Have received a live vaccine recently.
- Have a family member involved in the study or employed by the study site.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Kaiser Permanente Downey Medical Center | 90027 | Los Angeles | California |
| Children's Hospital of Orange County | 92057 | Orange | California |
| Rady Children's Hospital | 92123 | San Diego | California |
| Children's Hospital of Colorado | 80045 | Aurora | Colorado |
| Connecticut Children's | 06106 | Hartford | Connecticut |
| Nemours/ Alfred I duPont Hospital for Children | 19803 | Wilmington | Delaware |
| Johns Hopkins All Children's Hospital | 33701 | St. Petersburg | Florida |
| Children's Healthcare of Atlanta | 30322 | Atlanta | Georgia |
| Ann & Robert H. Lurie Children's Hospital of Chicago | 60611 | Chicago | Illinois |
| Johns Hopkins Medical Center | 21287 | Baltimore | Maryland |
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