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:
2025-12-26 @ 10:33 AM
Ignite Modification Date:
2025-12-26 @ 10:33 AM
NCT ID:
NCT02378428
Eligibility Criteria:
Inclusion Criteria:
* Patients must be between 12 months and 65 years at the time of enrollment
* Diagnosis: diagnosis of neuroblastoma or at the time of relapse by histology and/or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites
* Disease Status:
1. The presence of refractory or progressive disease (PD)
2. For patients with neuroblastoma, the presence of mixed response (MR), or no response (NR) following the completion of A3973 or equivalent induction therapy, or the presence of a partial response (PR) with high Curie score (\>2) following induction therapy.
3. Patients with de novo high risk neuroblastoma who have completed standard induction therapy and do not achieve a CR, VGPR, or PR with low Curie score post induction.
* Patients must have evidence of MIBG avid disease as determined by diagnostic MIBG scan obtained within 4 weeks of study entry.
* Patients who receive greater than 12 mCi/kg are required to have stem cell rescue products harvested prior to study treatment.
* Performance Level and Life Expectancy: Patients must have a Lansky Play Scale17 of 60% (\<16 yrs old), Karnofsky score 60% (\>16 yrs old), or ECOG score of \< or equal to 2 and a life expectancy of 2 months.
* Patients may enter this study with or without salvage therapy for recurrent tumor. Patients must have fully recovered from the toxic effects of any prior therapy.
* Organ Function requirements:
Hematopoietic Criteria:
1. Hemoglobin- 10 gl/dl (transfusion allowed)
2. ANC- 550 / cu mm (off myeloid growth factors)
3. Platelets- \> 50,000/cu mm. (transfusion allowed - however patients must not require more than two platelet transfusions per week).
Renal Function:
a. Serum Creatinine- \< 2 x ULN for age.
Hepatic Function:
Total bilirubin \<1.5 x ULN for age SGPT (ALT) and SGOT (AST) \< 10 x ULN for age
Cardiac Function:
For children with NBL: Normal ejection fraction (\>55%) documented by echocardiogram or radionuclide MUGA evaluation OR normal fractional shortening (\>27%) documented by echocardiogram.
For subjects with paraganglioma/ pheochromocytoma: No clinically significant cardiac dysfunction.
Pulmonary Function:
Patients must have clinically normal lung function as manifested by no dyspnea at rest and no oxygen requirement
Reproductive Function:
1. Females of childbearing potential must have a negative pregnancy test within 1 week prior to treatment with 131I-MIBG.
2. Patients of childbearing potential must agree to use an effective birth control method.
3. Female patients who are lactating must agree to stop breast feeding
Exclusion Criteria:
* Pregnancy or breast feeding
* Have undergone a prior allogeneic BMT.
* Patients with disease of any major organ system that would compromise their ability to withstand therapy. Any significant organ impairment should be discussed with the Study Chair prior to patient entry.
* Patients who are on hemodialysis.
* Hepatitis B surface antigen (+) or Hepatitis C positive in preceding six months.
* Patients with an active infection requiring intravenous antivirals, antibiotics or antifungals. Patients on prolonged antifungal therapy are still eligible if they are culture negative and biopsy negative in suspected residual radiographic lesions have stabilized or regressed and they meet other organ function criteria.
* Prior total body irradiation, prior total abdominal or whole liver radiation
* Any medical or psychological condition or situation deemed by the PI to put the patient at increased risk of complications or noncompliance.
* Patients with curative treatment options.
* Patients for whom busulfan/ melphalan consolidation therapy following treatment with 131I-MIBG is planned.
* Patients for who CEM (carboplatin, etoposide, melphalan) therapy is administered within 30 days prior to 131I-MIBG therapy or for whom this therapy is planned within 30 days following administration of 131I-MIBG.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Months
Maximum Age:
65 Years
Study:
NCT02378428
Study Brief:
Protocol Section:
NCT02378428