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Stem Cell Transplant and Zoledronic Acid for Solid Tumors

This study is looking at a new way to treat certain solid tumors like neuroblastoma and rhabdomyosarcoma in children and young adults (ages 6 months to 25 years). It involves a stem cell transplant where specific immune cells (alpha/beta T-cells and B-cells) are removed using a device called Miltenyi CliniMACS Prodigy®. This helps reduce side effects like graft-versus-host disease (aGVHD). Participants will also receive zoledronic acid, a drug given through an IV, multiple times after the transplant. The study aims to see how many patients are free of their disease one year after transplant and how often aGVHD occurs within two years. This trial is for patients whose solid tumors have returned or are hard to treat, especially if other transplant options aren't suitable.

Study design
This interventional study plans to enroll 27 participants. The first three participants will receive a specific dose of zoledronic acid to help determine the best dose for future participants.
What's involved
Participants will receive an allogeneic stem cell transplant and intravenous zoledronic acid on days +28, +56, +84, +112, and +140 after the transplant.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for disease-free survival for one year and for the incidence of aGVHD for two years after the transplant.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06625190

Alpha/Beta T and B Cell Depletion With Zoledronic Acid for Solid Tumors

Recruiting
PHASE1Ages 6–25InterventionalTreatment
University of Florida
~27 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:Miltenyi CliniMACS Prodigy ® systemZoledronic acid

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Disease-free survival rate
Measured over 1 year post-transplant
+1 more outcome measured

Conditions

Neuroblastoma
Rhabdomyosarcoma
Synovial Sarcoma
Peripheral Nerve Sheath Tumors
Clear Cell Sarcoma
Alveolar Soft Part Sarcoma
Desmoplastic Small Round Cell Tumor
Chordoma
Rhabdoid Tumor
Epithelioid Sarcoma
Myoepithelial Tumor
Osteosarcoma
Ewing Sarcoma
Wilms Tumor

Explore related trials

Alveolar Soft Part SarcomaChordomaClear Cell Sarcoma of Soft TissueDesmoplastic Small Round Cell TumorEpithelioid SarcomaEwing SarcomaMalignant Peripheral Nerve Sheath TumorMyoepithelial TumorNeuroblastomaOsteosarcomaRhabdoid TumorRhabdomyosarcomaSolid NeoplasmSynovial SarcomaWilms Tumor

NCT06625190

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Florida

    Gainesville, Floridastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jordan Milner, MD · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

Giselle Moore-Higgs, PhD, APRN
[email protected]
352-273-9050
Email the study team

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Eligibility criteria

Inclusion

Patients 6 months to ≤ 25 years old
Relapsed/Refractory Solid Tumor whom failed or deemed ineligible to receive autologous transplant or if autologous transplant did not offer \>20% chance of cure with the following diseases:
Subjects must not have more than one active malignancy at the time of enrollment. (Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen \[as determined by the treating physician and approved by the PI\] may be included.)
Haplo-identical related donor (at least one full haplotype must be matched).
Karnofsky or Lansky score ≥60% at the time of enrollment. Karnofsky scores must be used for patients \>16 years of age and Lansky scores for patients ≤16 years of age
Adequate organ function (within 4 weeks of initiation of preparative regimen), defined as:
Written informed consent obtained from the subject and the subject agrees to comply with all the study-related procedures
Individuals of childbearing potential (IOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for one year following transplantation to minimize the risk of pregnancy. Prior to study enrollment, individuals of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factor for an unintentional pregnancy.
Subjects with female partners of child-bearing potential must agree to use physician-approved contraceptive methods (e.g., abstinence, condoms, vasectomy) throughout the study and should avoid conceiving children for one year following stem cell transplantation.
Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one year after transplantation.
Females who are known to be pregnant or breastfeeding.
History of any other disease, metabolic dysfunction, clinical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
Prisoners or subjects who are involuntarily incarcerated, or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.

Exclusion

Patients with documented uncontrolled infection at the time of study entry are not eligible.
Patients with progressive solid tumor disease after relapsed/refractory treatment.
Demonstrated lack of compliance with medical care, as determined by the treating physician.
Patients who have received an allogeneic HSCT within 6 months.
Patients who do not have an eligible allogeneic donor available.
Patients with a life expectancy \<3 months

What this trial measures

  • Disease-free survival rate1 year post-transplant

    Determine the disease-free survival rate at 1 year post-transplant

  • Incidence of aGVHD2 years post-transplant

    Determine the incidence of grade II-IV acute graft versus host disease (aGVHD)