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New treatment option for Neuroblastoma
Official title Alpha/Beta T and B Cell Depletion With Zoledronic Acid for Solid Tumors
ClinicalTrials.gov ID: NCT06625190
What this study is testing
What is Zoledronic acid?
Zoledronic acid is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for neuroblastoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 25
You may be able to join if
- 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%...
- neuroblastoma (high risk with relapsed or refractory disease),
- relapsed/refractory rhabdomyosarcoma,
- relapsed/refractory non-rhabdomyosarcoma soft tissue sarcoma (NRSTS): synovial sarcoma, malignant peripheral nerve sheath tumors (MPNST),
You likely can't join if
- Patients with documented uncontrolled infection at the time of study entry are not eligible. a. Uncontrolled infection is patient without treatment...
- 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
See the full eligibility 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:
- neuroblastoma (high risk with relapsed or refractory disease),
- relapsed/refractory rhabdomyosarcoma,
- relapsed/refractory non-rhabdomyosarcoma soft tissue sarcoma (NRSTS): synovial sarcoma, malignant peripheral nerve sheath tumors (MPNST),
- High risk adult type NRSTS: clear cell sarcoma, alveolar soft part sarcoma,
- Other high-risk extracranial solid tumors: desmoplastic small round cell tumors, chordoma, malignant rhabdoid tumor, epithelioid sarcoma, myoepithelial tumor
- relapsed/refractory bone tumors: osteosarcoma and Ewing sarcoma/PNET, or
- Wilm's tumor or other high-risk solid tumors with \<10% expected survival with conventional treatment.
- people must not have more than one active malignancy at the time of enrollment. (people with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety...
- 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:
- 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...
- Renal: Creatinine clearance or radioisotope GFR ≥60 mL/min/1.73 m2 or a serum creatinine based on age/gender
- 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...
- people 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...
- 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...
- Prisoners or people who are involuntarily incarcerated, or people who are compulsorily detained for treatment of either a psychiatric or physical illness.
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.