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Protocol No. UW17135

Principal Investigator Otto, Mario

Phase I

Age Group Children

Scope National

Sponsor Type Industry; Institutional

Title  A Phase 1, Open-Label, Dose Escalation Study of CLR 131 in Children and Adolescents with Select Solid Tumors, Lymphoma, and Malignant Brain Tumors

Objective The primary purpose of this study is to determine the dose of CLR 131 that can be given safely and find out about any side effects and problems that the drug can cause. We will also study the effect of the drug on your cancer. CLR 131 is an investigational, radioactive drug. The word "investigational" means that CLR 131 is not approved by the U.S. Food and Drug Administration(FDA) and is available for research use only
Radiotherapy is a type of cancer therapy that uses high energy x-rays or other particles to destroy cancer cells. It has been used to treat cancer for more than 40 years. This study uses a form of radiotherapy called "targeted" radiotherapy. In targeted radiotherapy, we attach the radiation to a "marker" which takes it directly to the tumor. In this study, the "marker" is CLR131

Treatment The day before given CLR131, patients will start potassium iodide drops(supplied by study), to help prevent damage to the thyroid gland. These drops will continue for 45 days after the dose of CLR131 is given for a total of 46 total days
On Day 1 you will receive a single injection of CLR131 through an intravenous injection(IV) over approximately 30 minutes. Not all will get the same dose of CLR131, at the beginning of the study a few participants will be treated with low doses of the drug. After a dose is tested and found to be safe, the next participant will receive a higher dose. CLR131 will be gradually increased until the highest, safe dose is found
All patients receiving CLR131 at a dose greater than 30 mCi/m2 must have cryopreserved autologous stem cells available for stem cell rescue

Description Phase 1 study of CLR131 in Children with Solid Tumors, Lympohma, and Brain Tumors

Key Eligibility
  • Previously confirmed (histologically or cytologically) 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
  • Patient is greater than or equal to 2 years and less than or equal to 21 years of age at time of consent/assent
  • Patients greater than or equal to age 16 must have a Karnofsky performance status of greater than or equal to 60. Patients less than age 16 must have a Lansky performance status of greater than or equal 60
  • Must have adequate organ and bone marrow function as described by the protocol
  • Patients who have undergone autologous bone marrow transplant must be at least 3 months from transplant
  • Patients enrolling at dose levels greater than 30 mCi/m2 must have availability or ability to collect an autologous stem cell back-up product prior to CLR 131 administration
  • 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
    Pediatric Solid Tumor or Lymphoma Patients: At least 1 measurable lesion with longest diameter of at least 15 mm, Patients with a lesion(s) that are determined to be MIBG or 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
    Recurrent or Refractory Malignant Brain Tumor Patients: At least 1 measurable lesion with longest diameter of at least 10 mm on any imaging sequence, patients with neurological deficits must be clinically stable, patients must be on a stable dose of steroids
    EXCLUSION
  • Patients receiving active treatment for brain metastases
  • Central nervous system involvement unless previously treated with surgery, systemic therapy, or radiotherapy with the patient neurologically stable
  • Antitumor therapy or investigational therapy, within 2 weeks of registration. For certain types of radiation (craniospinal, total abdominal, whole lung [spot irradiation to skull-based metastases is not considered craciospinal radiation for the purposes of this study]), at least 3 months must have elapsed
  • History of hypersensitivity to iodine
  • Known history of human immunodeficiency virus or uncontrolled, serious, active infection
  • Pregnancy or breast-feeding
  • Patients previously treated with I-MIBG who have already received a cumulative I-131 dose greater than 54 mCi/kg or who would exceed 54 mCi/kg by participating in this trial, are not eligible
  • Any other concomitant serious illness or organ system dysfunction (including cardiac and pulmonary dysfunction) that in the opinion of the Investigator would either compromise patient safety or interfere with the evaluation of the safety of the test drug

  • Applicable Disease Sites Anal; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Ill-Defined Sites; Kidney; Liver; Lung; Lymphoma; Melanoma/Skin cancer; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Uterus

    Status Open

    Participating Institutions UW Hospital and Clinics