Study on Alpha/Beta T and B Cell Depletion with Zoledronic Acid for Treating Solid Tumors
Sponsor: University of Florida
ClinicalTrials ID:NCT06625190
This clinical trial is exploring a new treatment approach using a combination of stem cell transplants and the drug zoledronic acid to improve outcomes for children and young adults with certain difficult-to-treat solid tumors.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to test the safety and effectiveness of a new treatment for children and young adults with certain solid tumors that have not responded well to previous treatments. This treatment involves using a special type of stem cell transplant that removes certain immune cells (αβ-T cells and B cells) and combines it with a drug called zoledronic acid. The goal is to see if this approach can help the immune system fight the cancer more effectively and improve survival rates.
Eligibility Criteria
Inclusion Criteria
- Patients must be 25 years old or younger.
- Have a solid tumor that has come back or not responded to treatment, and for which a previous transplant was not successful or not an option.
- Types of eligible tumors include:
- High-risk neuroblastoma
- Relapsed or refractory rhabdomyosarcoma
- Certain types of soft tissue sarcomas
- High-risk non-rhabdomyosarcoma soft tissue sarcomas
- Other high-risk extracranial solid tumors
- Relapsed or refractory bone tumors like osteosarcoma and Ewing sarcoma
- Other high-risk solid tumors with less than 10% expected survival with standard treatment
- Must not have more than one active cancer at the time of joining the study.
- Must have a partially matched family donor for the transplant.
- Must be in relatively good health, with a performance score of 60% or higher.
- Must have adequate organ function, including:
- Good lung function or no breathing problems
- Good kidney function
- Good heart function
- Must agree to use effective birth control during the study and for one year after the transplant.
- Must provide written consent to participate in the study.
Exclusion Criteria
- Cannot have an uncontrolled infection at the time of joining the study.
- Cannot have shown a lack of compliance with medical care.
- Cannot have had a previous allogeneic stem cell transplant within the last 6 months.
- Must have an eligible donor available for the transplant.
- Cannot have a life expectancy of less than 3 months.
- Must meet the organ function criteria.
- Cannot be pregnant or breastfeeding, and must agree to use birth control if of childbearing potential.
- Cannot have any other condition that might interfere with the study or increase the risk of complications.
- Cannot be a prisoner or involuntarily detained for treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Florida | 32610 | Gainesville | Florida |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.
