27 Participants Needed

Zoledronic Acid for Cancer

BG
Overseen ByBeate Greer
Age: < 65
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: University of Florida
Must be taking: Zoledronic acid
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

JM

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

I do not have more than one active cancer.
I am 25 years old or younger.
My condition is high-risk neuroblastoma that has returned or is not responding to treatment.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a stem cell graft depleted of αβ-T cell and CD19+ B cells in combination with zoledronic acid

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of aGVHD and survival rates

2 years

What Are the Treatments Tested in This Trial?

Interventions

  • Alpha/Beta T and B Cell Depletion
  • Zoledronic Acid
Trial Overview The study tests the safety of a new therapy combining αβ-T cell/B cell-depleted stem cell transplants with zoledronic acid in children and young adults with certain solid tumors. It aims to enhance the immune system's ability to fight cancer and improve survival rates.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: alpha/beta T cell and CD19+ B cell depleted stem cell graft with zoledronic acidExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials
1,428
Recruited
987,000+

Published Research Related to This Trial

In a mouse model of breast cancer, combining the anti-PD-1 antibody with zoledronic acid (ZA) resulted in a stronger anti-tumor response compared to either treatment alone, indicating a potential synergistic effect.
The combination therapy showed no obvious toxicity, suggesting it could be a safe and effective approach for enhancing breast cancer treatment.
PD-1 blockade in combination with zoledronic acid to enhance the antitumor efficacy in the breast cancer mouse model.Li, Y., Du, Y., Sun, T., et al.[2019]
In a study of 45 patients with limited metastatic bone cancer, combining zoledronic acid with local radiotherapy resulted in a significantly higher rate of bone recalcification (52.2%) compared to radiotherapy alone (22.7%).
The combination therapy also reduced the formation of new bone metastases (13.0% in the combination group vs. 40.9% in the radiotherapy alone group), indicating a potential benefit in managing metastatic bone cancer.
[Clinical analysis of therapeutic effect of zoledronic acid combined with radiotherapy for metastatic bone cancer].Cheng, J., Xue, J., Wu, HG., et al.[2018]
Zoledronic acid (ZOL) has shown potential anticancer activity across various cancer types, with evidence from clinical trials indicating survival benefits for patients with advanced cancers.
In early breast cancer patients, ZOL not only improves disease-free survival but also reduces the presence of tumor cells and decreases the size of residual invasive tumors, suggesting it may have significant clinical benefits beyond its role in preventing skeletal-related events.
Anticancer evidence for zoledronic acid across the cancer continuum.Costa, L., Harper, P., Coleman, RE., et al.[2018]

Citations

Zoledronic acid inhibits NFAT and IL-2 signaling pathways in regulatory T cells and diminishes their suppressive function in patients with metastatic cancer. [2023]
PD-1 blockade in combination with zoledronic acid to enhance the antitumor efficacy in the breast cancer mouse model. [2019]
[Clinical analysis of therapeutic effect of zoledronic acid combined with radiotherapy for metastatic bone cancer]. [2018]
Anticancer evidence for zoledronic acid across the cancer continuum. [2018]
Zoledronic acid modulates antitumoral responses of prostate cancer-tumor associated macrophages. [2018]
The effect of zoledronic acid on the function and differentiation of myeloid cells. [2018]
[Clinical study of zoledronic acid in the treatment of cancer-induced hypercalcemia]. [2018]
Zoledronic acid significantly reduces skeletal complications compared with placebo in Japanese women with bone metastases from breast cancer: a randomized, placebo-controlled trial. [2022]
Zoledronic acid causes γδ T cells to target monocytes and down-modulate inflammatory homing. [2021]
Zoledronic acid blocks the interaction between breast cancer cells and regulatory T-cells. [2020]
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