Zoledronic Acid for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
Hematopoietic stem cell transplantation can cure patients with blood cancer and other underlying diseases. αβ-T cell and B cell depletion has been introduced to decrease GVHD and PTLD and has demonstrated effectiveness for hematologic malignancies and non-malignant diseases additionally increasing the donor pool as to allow for haploidentical transplant to safely occur.While solid tumors can be highly chemotherapy sensitive, many remain resistant and require multimodalities of treatment. Immunotherapy has been developed to harness the immune system in fighting solid tumors, though not all have targeted effects. Some solid tumors are treated with autologous transplants; however, they do not always demonstrate an improved event free survival or overall survival. There has been evidence of the use of allogeneic stem cell transplants to provide a graft versus tumor effect, though studies remain limited.By utilizing αβ-T cell and B cell depletion for stem cell transplants and combining with zoledronic acid, the immune system may potentially be harnessed and enhanced to provide an improved graft versus tumor effect in relapsed/refractory solid tumors and promote an improved event-free survival and overall survival.This study will investigate the safety of treatment with a stem cell graft depleted of αβ-T cell and CD19+ B cells in combination with zoledronic acid in pediatric and young adult patients with select solid tumors, as well as whether this treatment improves survival rates in these patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get a clear answer.
Is zoledronic acid safe for humans?
Zoledronic acid has been studied for safety in various conditions, including bone metastases from breast cancer and cancer-induced high calcium levels. It is generally considered safe, but like any medication, it may have side effects, and its safety profile should be discussed with a healthcare provider.12345
How does the drug zoledronic acid differ from other treatments for cancer?
Zoledronic acid is unique because it not only inhibits bone resorption but also modulates the immune system by reducing the suppressive function of regulatory T cells, enhancing the body's anti-tumor immune response. This dual action makes it different from other cancer treatments that typically focus on directly targeting cancer cells.12678
What data supports the effectiveness of the drug zoledronic acid for cancer treatment?
Research shows that zoledronic acid can reduce the suppressive function of regulatory T cells, which helps boost the body's immune response against cancer. It also has been shown to improve survival rates and reduce tumor size in various cancers, suggesting it has potential anticancer benefits.126910
Who Is on the Research Team?
Jordan Milner, MD
Principal Investigator
University of Florida
Are You a Good Fit for This Trial?
This trial is for pediatric and young adult patients (≤25 years old) with specific high-risk solid tumors, including various sarcomas, neuroblastoma, bone cancers like osteosarcoma and Ewing sarcoma that have relapsed or are refractory to treatment. Participants must have a related donor for stem cell transplant, good physical function scores (Karnofsky/Lansky ≥60%), and acceptable lung function. They cannot be enrolled if they have more than one active cancer.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a stem cell graft depleted of αβ-T cell and CD19+ B cells in combination with zoledronic acid
Follow-up
Participants are monitored for safety and effectiveness after treatment, including incidence of aGVHD and survival rates
What Are the Treatments Tested in This Trial?
Interventions
- Alpha/Beta T and B Cell Depletion
- Zoledronic Acid
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor