Is NCT06625190 recruiting in Gainesville, FL?

Yes, NCT06625190 is currently recruiting participants at its Gainesville, FL location. This neuroblastoma clinical trial is actively enrolling qualified participants.

How do I join the neuroblastoma clinical trial in Gainesville?

To join this clinical trial in Gainesville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Gainesville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Neuroblastoma Clinical Trial in Gainesville, FL

About This Neuroblastoma Study in Gainesville

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.

Sponsor: University of Florida

Who Can Participate

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:

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.

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:

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.

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 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.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Gainesville?

Yes, this clinical trial (NCT06625190) has an active research site in Gainesville, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Neuroblastoma Treatment Options in Gainesville, FL

If you're searching for neuroblastoma treatment options in Gainesville, FL, this clinical trial (NCT06625190) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Gainesville research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced neuroblastoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all neuroblastoma clinical trials near you to find additional studies recruiting in your area.

Neuroblastoma Clinical Trial in Gainesville, FL

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