- Previously confirmed (histological or cytological) pediatric solid tumor (e.g., neuroblastoma, sarcoma), lymphoma (including Hodgkin's lymphoma), or malignant brain tumors that are clinically or radiographically suspected to be relapsed, refractory, or recurrent for which there are no standard treatment options with curative potential
- ≥ 2 years of age and ≤ 21 years of age at time of consent/assent
- If ≥ age 16, Karnofsky performance status of ≥ 60. If < age 16, Lansky performance status ≥ 60
- Platelets ≥ 75,000/µL (last transfusion, if any, must be at least one week prior to study registration, and, unless deemed medically necessary, no transfusions are allowed between registration and dosing)
- Absolute neutrophil count ≥ 750/µL
- Hemoglobin ≥ 10 g/dL (last transfusion must be at least one week prior to study registration, and, unless deemed medically necessary, no transfusions are allowed between registration and dosing)
- Using the bedside Schwartz formula, age-based serum creatinine within 2 x upper limit of normal (ULN)
- Alanine aminotransferase < 3 × ULN
- Bilirubin < 2 × ULN
Patients who have undergone autologous bone marrow transplant must be at least 3 months from transplant.
- Patients enrolling at dose levels > 30 millicurie (mCi)/m2 must have availability or ability to collect an autologous stem cell back-up product prior to CLR 131 administration. At minimum, 2 x 10^6/kg cryopreserved CD34+ cells/kg must be available.
- Patient or his or her legal representative is judged by the Investigator to have the initiative and means to be compliant with the protocol.
- Patient or his or her legal representative has the ability to read, understand, and provide written informed consent for the initiation of any study-related procedures.
- Female patients of childbearing potential must have a negative pregnancy test at screening and within 24 hours of dosing. It is recommended that female caregivers of childbearing potential have a negative pregnancy test within one week of dosing.
- Patients of childbearing potential must practice an effective method of birth control while participating on this study to avoid possible damage to the fetus.
Patients with Pediatric Solid Tumor or Lymphoma
- At least one measurable lesion with longest diameter of at least 15 mm. Patients with a lesion(s) that are determined to be Metaiodobenzylguanidine (MIBG) or positron emission tomography (PET) positive may be enrolled at the investigator's discretion, even if not associated with a measurable lesion of at least 15 mm.
- Patients with known brain metastases must have completed any radiotherapy or systemic treatments for brain metastases prior to enrollment; by investigator assessment be considered stable with no new signs or symptoms for at least one month, and on a stable dose of steroids (unchanged for three weeks prior to screening).
Patients with Recurrent or Refractory Brain Tumors
- At least one measurable lesion with longest diameter of at least 10 mm on any imaging sequence.
- Patients with neurological deficits must be clinically stable at time of enrollment and able to complete all study related procedures. Patients with documented or newly diagnosed neurological deficits will be enrolled at the investigator's discretion.
- Patients must be on a stable dose of steroids (unchanged for three weeks prior to screening)