New stem cell approach aims to fight tough childhood cancers
NCT ID NCT06625190
First seen Jun 27, 2026 · Last updated Jul 01, 2026 · Updated 2 times
Summary
This study tests a special stem cell transplant for children, teens, and young adults (ages 6 months to 25 years) with solid tumors that have come back or not responded to treatment. The transplant uses cells from a donor, with certain immune cells removed to reduce side effects, and is combined with a drug called zoledronic acid to boost the immune system's ability to fight the cancer. The goal is to see if this approach is safe and can improve survival rates.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- stem cell transplant (depleted of certain immune cells) plus zoledronic acid
- What this could lead to
- If this works, it could offer a new treatment option for young patients with hard-to-treat solid tumors that have come back or not responded to other therapies.
- What could go wrong
- This is an early-phase trial with only 27 participants, so results are preliminary. The transplant carries risks like graft-versus-host disease and infection, and it may not improve survival.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 27 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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6 months to 25 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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: 1. neuroblastoma (high risk with relapsed or refractory disease), 2. relapsed/refractory rhabdomyosarcoma, 3. relapsed/refractory non-rhabdomyosarcoma soft tissue sarcoma (NRSTS): synovial sarcoma, malignant peripheral nerve sheath tumors (MPNST), 4. High risk adult type NRSTS: clear cell sarcoma, alveolar soft part sarcoma, 5. Other high-risk extracranial solid tumors: desmoplastic small round cell tumors, chordoma, malignant rhabdoid tumor, epithelioid sarcoma, myoepithelial tumor 6. relapsed/refractory bone tumors: osteosarcoma and Ewing sarcoma/PNET, or 7. Wilm's tumor or other high-risk solid tumors with \<10% expected survival with conventional treatment. * 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: 1. Pulmonary: FEV1, FVC, and corrected DLCO must all be ≥ 50% of predicted by pulmonary function tests (PFTs). For children who are unable to perform for PFTs due to age, the criteria are: no evidence of dyspnea at rest and no need for supplemental oxygen. 2. Renal: Creatinine clearance or radioisotope GFR ≥60 mL/min/1.73 m2 or a serum creatinine based on age/gender 3. Cardiac: Ejection fraction of ≥ 40% by echocardiogram or radionuclide scan (MUGA). * 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. Exclusion Criteria: * Patients with documented uncontrolled infection at the time of study entry are not eligible. a. Uncontrolled infection is patient without treatment antimicrobials and/or demonstrating progression despite antimicrobials * 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 * Patients not meeting inclusion criteria for organ function. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Florida
RECRUITINGGainesville, Florida, 32610, United States
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