Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT03209869
Eligibility Criteria:
Inclusion Criteria:
* Relapsed or refractory neuroblastoma
* Relapsed or refractory Osteosarcoma
* Karnofsky/Lansky performance score \> 50
* Life expectancy ≥ 4 months
* Creatinine clearance or radioisotope GFR ≥ 60 ml/min/1.73m2 OR serum creatinine within normal limits based on age and gender
* ANC ≥ 750/µL
* Platelet count ≥ 50,000/µL
* Hemoglobin ≥ 8 g/dL
* Total bilirubin ≤ 1.5 x upper limit of normal for age
* ALT (SCPT) ≤ 5 x upper limit of normal for age
* Shortening fraction of ≥ 27% by echocardiogram OR Ejection fraction of ≥55% by MUGA
* No evidence of dyspnea at rest
* Pulse oximetry \> 94% on room air
* If PFTs performed, FEV1/FVC must be \> 60%
* All Osteosarcoma patients must have PFTs performed
* CNS toxicity ≤ Grade 2
* Patients with seizure disorders may be enrolled if seizures are well controlled on anticonvulsant therapy
* \> 100 days after autologous stem cell infusion following myeloablative therapy
* ≥ 2 weeks since chemotherapy
* ≥ 7 days since anti-neoplastic, non-myelosuppressive biologic agent (or extended for agents known to have adverse events beyond the 7- day period)
* ≥ 2 weeks for local palliative XRT
* ≥ 6 months if prior craniospinal axis XRT (\> 50%)
* ≥ 6 months if \> 50% radiation of pelvis
* ≥ 6 weeks after therapeutic 131I-MIBG
* ≥ 6 weeks since thoracotomy
* Informed consent obtained (patient or legal representative)
* Women of reproductive potential must have negative pregnancy test and be willing to use effective birth control method
* Suitable haploidentical donor must be available
Exclusion Criteria:
* Prior history of ventilator support related to lung injury, except for immediately following thoracotomy
* Symptomatic pleural effusions or ascites
* \<6 weeks from thoracotomy and \<2 weeks from other major surgery
* History of anaphylaxis while receiving prior anti-GD2 therapy
* Pregnant
* HIV infection
* Heart failure or uncontrolled cardiac rhythm disturbance
* Active infection
* Prior organ allograft
* Prior allogeneic bone marrow or peripheral blood stem cell transplant
* Significant serious intercurrent illnesses expected to interfere with the antitumor effect of treatment or to significantly increase the severity of toxicities experienced from treatment
* Any mental or physical condition, in the opinion of the PI (or PI designee), which could interfere with the ability of the subject (or the only parent or legal guardian available to care for the subject) to understand or adhere to the requirements of the study.
* Enrollment in any other treatment study from screening up to 28 days after the last treatment on this study (unless PI judges such enrollment would not interfere with endpoints of this study)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Months
Maximum Age:
25 Years
Study:
NCT03209869
Study Brief:
Protocol Section:
NCT03209869