131-I-MIBG Therapy for Refractory Neuroblastoma and Metastatic Pheochromocytoma (CHP-830)

Expanded access is currently available for this treatment.
Verified January 2014 by Children's Hospital of Philadelphia
Sponsor:
Information provided by (Responsible Party):
John Maris, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01163383
First received: July 13, 2010
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

Metaiodobenzylguanidine (MIBG) is a substance that is taken up by neuroblastoma or pheochromocytoma tumor cells. MIBG is combined with radioactive iodine (131 I)in the laboratory to form a radioactive compound 131 I-MIBG. This radioactive compound delivers radiation specifically to the cancer cells and causes them to die.

The purpose of this research protocol is to provides a mechanism to deliver MIBG therapy when clinically indicated, but also to provide a mechanism to continue to collect efficacy and toxicity data that will be provided


Condition Intervention
Neuroblastoma
Metastatic Pheochromocytoma
Drug: 131 I-Metaiodobenzylguanidine (131 I-MIBG)
Drug: 131 I-MIBG

Study Type: Expanded Access     What is Expanded Access?
Official Title: CHP-830 I-Metaiodobenzylguanidine (131 I-MIBG) Therapy for Refractory Neuroblastoma and Metastatic Pheochromocytoma (An Expanded Access Protocol)

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Study Start Date: March 2005
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: 131 I-Metaiodobenzylguanidine (131 I-MIBG)
    131 I-MIBG 1-18mCi/kg given intravenously on day 1. Subjects may receive multiple courses every 4-8 weeks depending on the dose given.
    Other Names:
    • MIBG
    • 131 I-Metaiodobenzylguanidine
    • radioactive Iodine (131)
    • Metaiodobenzylguanidine
    Drug: 131 I-MIBG
    131-I-MIBG will be infused intravenously over 60-90 minutes once per course. The dose will be determined by the treating physician.
    Other Names:
    • 131 I- Metaidobenzylguanidine
    • MIBG
    • Radioactive iodine
    • Metaiodobenzylguanidine therapy
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Refractory or relapsed neuroblastoma with original diagnosis based on tumor histopathology or elevated urine catecholamines with typical neuroblastoma cells in the bone marrow OR Metastatic Pheochromocytoma
  • Age greater than 1 year and able to cooperate with radiation safety restrictions during therapy period.
  • Performance Level: Patients must have a Karnofsky or Lansky performance status of equal to or greater than 50 percent
  • Disease status: Failure to respond to standard therapy (usually combination chemotherapy with or without radiation and surgery) or development of progressive disease at any time (any new lesion or an increase in size of >25% of a pre-existing lesion).
  • Disease evaluable by MIBG scan must be present within 8 weeks of study entry and subsequent to any intervening therapy. The principal or co-investigator can waive the requirement for intervening therapy if in their judgment this would pose undue risk and would not affect ability to judge treatment effectiveness.
  • Stem cells: Patients must have a hematopoietic stem cell product available for re-infusion after MIBG treatment at doses of 12 mCi/kg. The minimum quantity for peripheral blood stem cells is 1.0 x 106 CD34+ cells/kg
  • Prior Therapy: Patients may enter this study with or without re-induction therapy for recurrent tumor. Patients must have fully recovered from the toxic effects of any prior therapy. Subjects cannot be receiving chemotherapy, cytokine therapy or other investigational agents, and must have fully recovered from the toxic effects of any prior therapy.
  • Liver function: Bilirubin ≤2x upper limit of normal; AST/ALT ≤10x upper limit of normal
  • Kidney function: Creatinine ≤3x upper limit of normal
  • Signed informed consent: The patient and/or the patient's legally authorized guardian must provide written informed consent to participate in this expanded access protocol.

Exclusion criteria

  • Patients with disease of any major organ system that would compromise their ability to withstand therapy, as deemed by the principal investigator or treating sub-investigator.
  • Because of the teratogenic potential of the study medications, no patients who are pregnant or lactating will be allowed. 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 who are on hemodialysis
  • Patients with uncontrolled infections
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163383

Contacts
Contact: John Maris, MD maris@email.chop.edu
Contact: Yael Mosse, MD mosse@email.chop.edu

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: John M Maris, MD Children's Hospital of Philadelphia
  More Information

Additional Information:
No publications provided

Responsible Party: John Maris, Director of Children's Hospital Cancer Center, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01163383     History of Changes
Other Study ID Numbers: 2005-02-4159
Study First Received: July 13, 2010
Last Updated: January 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Children's Hospital of Philadelphia:
Refractory Neuroblastoma
Recurrent Neuroblastoma
Neuroblastoma
stage IV neuroblastoma
metastatic pheochromocytoma

Additional relevant MeSH terms:
Neuroblastoma
Pheochromocytoma
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Paraganglioma
Neuroendocrine Tumors
3-Iodobenzylguanidine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014