TheranosticTrials.org

Clinical Trial · NCT00992173

Efficacy and Safety of Ultratrace™ Iobenguane I 131 in Neuroblastoma

Overview

This is a multi-center, single arm trial of two doses of 18 mCi/kg of Ultratrace iobenguane I 131 administered to subjects with high-risk neuroblastoma. Iobenguane I 131 is a drug that has already been used in many children to treat neuroblastoma, and it is known to shrink some of the tumors, and cause manageable side effects. When administered intravenously, Iobenguane I 131 accumulates in the neuroblastoma cancer cells and causes them to die. In this study the investigators are investigating the use of a new form of Iobenguane I 131 called Ultratrace iobenguane I 131. This form is expected to deliver higher amounts of radioactive I 131 to the neuroblastoma cells. The primary purpose of the study is to determine if Ultratrace iobenguane I 131 can be used to successfully treat high-risk neuroblastoma. The study will also assess the safety of Ultratrace iobenguane I 131 when given to patients with high-risk neuroblastoma.

Sponsor

Bivision Pharmaceuticals, Inc.

Phase

Phase 2

Contacts

Norman LaFrance, MD (STUDY_DIRECTOR)

ClinicalTrials.gov

NCT00992173

Drug / Compound

iobenguane

Isotope(s):
Target(s):
  • NET
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Have high-risk neuroblastoma with relapsed/refractory disease at any time.
  • MIBG avid disease demonstrated by 131I or 123I -MIBG uptake into tumor at ≥ one site within 28 days prior to study treatment and no intervention/therapy between the time of the MIBG scan and study treatment.
  • The last dose of any myelosuppressive or biologic (e.g., isotretinoin \[also known as cis-retinoic acid, or Accutane®\]) therapy must be at least 14 days before the administration of the first therapeutic dose of Ultratrace iobenguane I 131 on this protocol.
  • The last dose of all local palliative radiation must be ≥ 14 days prior to the first therapeutic dose of Ultratrace iobenguane I 131. Any lesion treated with local palliative radiation during this period can not be included in the baseline target lesion evaluation.
  • Adequate renal, hepatic, cardiac, lung and thyroid function
  • Prior autologous stem cell infusion must be ≥2 months prior to study entry. The patient must have recovered from all toxicities
  • Administration of Neuroblastoma therapeutic investigational medication or devices must be ≥30 days prior to dosimetry dose.
  • Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study. There is no limitation on the number of prior chemotherapeutic regimens that the patient may have received.
  • Adequate Organ Function:
  • Have a diagnosis of neuroblastoma either by (a) histologic verification of neuroblastoma and/or (b) demonstration of tumor cells in the bone marrow with increased urinary catecholamine metabolites
  • To be eligible to receive at least one therapeutic dose, patients must have adequate banked autologous stem cells defined as: PBSC: A minimum of 2.0 x 106 viable CD34+ cells/kg (purged or unpurged) (see Section 10.4.15)
  • Prior Therapy:
  • Prior treatment with 131I-MIBG therapy must be ≥12 months prior to the first therapeutic dose of Ultratrace iobenguane I 131.
  • The last dose of all local palliative radiation to more than 25% of marrow containing bones must be ≥ 28 days prior to the first therapeutic dose of Ultratrace iobenguane I 131. A minimum of 3 months is required following prior large field radiation therapy (i.e. craniospinal therapy, total lung, \> 50% marrow space). Note: Radiation therapy of focal skull-based bony metastatic disease (only) is not considered craniospinal therapy.
  • All cytokines or hematopoietic growth factors must be discontinued for a minimum of 7 days prior to the first therapeutic dose of Ultratrace iobenguane I 131or 14 days prior to the first therapeutic dose of Ultratrace iobenguane I 131for long-acting colony stimulating factors.
  • Adequate bone marrow function requirements, including patients post-myeloablative therapy or tumor involvement of bone marrow
  • The last dose of immunotherapy must be at least 28 days prior to the first therapeutic dose of Ultratrace iobenguane I 131.

Exclusion

  • Status post-allogeneic hematopoietic stem cell transplant.
  • Any other condition, that in the opinion of the investigator, may compromise the safety or compliance of the subject or would preclude the subject from successful completion of the study.
  • Is platelet transfusion dependent
  • Patient unable to receive at least one 15 mCi/kg dose per dosimetry findings.
  • Patients will be excluded if any of the following conditions are observed:
  • Have a known allergy to iobenguane, iodine or SSKI.
  • Have disease of any major organ system that would compromise their ability to withstand therapy.
  • If patients and/or families who are physically and psychologically unable to cooperate with the radiation safety isolation or imaging requirements (sedation or general anesthesia permitted).
  • Receiving hemodialysis or have a renal obstruction, which would effect the urinary excretion of MIBG.
  • Concomitant use of medications that inhibit uptake of Ultratrace iobenguane I 131.
  • Administered prior chemotherapy within 30 days of study entry or have active malignancy (other than neuroblastoma) requiring additional treatment.