Zoledronic Acid for Cancer

Recruiting in Palo Alto (17 mi)

Overseen byJordan Milner, MD

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Florida

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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.

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Participant Groups

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.

1Treatment groups

Experimental Treatment

Group I: alpha/beta T cell and CD19+ B cell depleted stem cell graft with zoledronic acidExperimental Treatment2 Interventions