Study on Alpha/Beta T and B Cell Depletion with Zoledronic Acid for Treating Solid Tumors

Sponsor: University of Florida

Sponsor score: 60

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

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

FACILITYZIPCITYSTATE
University of Florida32610GainesvilleFlorida

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.