ULTRATRACE Iobenguane I 131 in Patients With Malignant Pheochromocytoma, Paraganglioma, or Metastatic Carcinoid

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00339131
First received: June 17, 2006
Last updated: October 7, 2011
Last verified: October 2011
  Purpose

The purpose of this study is to test the safety of a drug called Ultratrace iobenguane I 131 that has radioactivity, to measure how long it takes for the drug to be absorbed and passed out of the body, and to measure how much radioactivity is absorbed into different tissues of the body.


Condition Intervention Phase
Pheochromocytoma
Paraganglioma
Carcinoid
Drug: Ultratrace iobenguane I 131
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Phase 1 Study Evaluating the Safety, Distribution, Metabolism, and Radiation Dosimetry of ULTRATRACE Iobenguane I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma or Metastatic Carcinoid

Resource links provided by NLM:


Further study details as provided by Molecular Insight Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • whole body imaging immediately post-dose
  • whole body imaging 1 hour post-dose
  • whole body imaging 3 hours post-dose
  • whole body imaging 6 hours post-dose
  • whole body imaging 24 hours post-dose
  • whole body imaging 48 hours post-dose
  • whole body imaging 120 hours post-dose

Secondary Outcome Measures:
  • blood and urine samples pre-dose
  • blood and urine samples immediately post-dose
  • blood and urine samples 1 hour post-dose
  • blood and urine samples 3 hours post-dose
  • blood and urine samples 6 hours post-dose
  • blood and urine samples 24 hours post-dose
  • blood and urine samples 48 hours post-dose
  • blood and urine samples 120 hours post-dose
  • continuous urine samples at intervals of 0-6 hours, 6-24 hours, 24-48 hours, 48-72 hours, 72-96 hours and 96-120 hours post-dose
  • monitoring for adverse events starting when the patient consents to be in the study until 2 weeks post-dose

Estimated Enrollment: 24
Study Start Date: June 2006
Study Completion Date: January 2007
Detailed Description:

Iobenguane, which is also known as MIBG, has been used in many patients who have types of cancers caused by what are known as neuroendocrine tumors, such as pheochromocytoma, paraganglioma, and carcinoid. Iobenguane is absorbed by neuroendocrine tumor cells. The radioactive portion of the study drug, Ultratrace iobenguane, is a form of iodine called I 131. The I 131 is absorbed into the tumor with the iobenguane, and the radioactivity should kill the tumors. The type of iobenguane being studied is called Ultratrace because of the new way in which this form of iobenguane is made. This study is the first time in which Ultratrace iobenguane will be given to patients. The purpose of the study is to give a low dose of iobenguane just to find out if the drug is safe, to measure how long it takes the drug to be absorbed and passed out of the body, and to see how much radioactivity is absorbed by different types of tissues of the body.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients will enter one of two study arms depending on their type of neuroendocrine tumor.

Arm P patients must:

  • Have a biochemical or histopathological diagnosis of either adrenal pheochromocytoma or extra-adrenal paraganglioma (biochemical diagnosis includes plasma-free metanephrines and 24-hour urine test for catecholamines/metanephrines)
  • Disease is metastatic or has recurred following surgery
  • Have a CT scan performed (for later measurement of disease volume by the core lab) within 90 days of the administration of study drug without any interventions between CT and iobenguane I 131 imaging.

Arm C patients must:

  • Have a histopathological diagnosis of carcinoid, or by plasma chromogranin A (CgA) and 24-hour urine test for 5-hydroxyindole-acetic-acid (5HIAA)
  • Disease is metastatic or has recurred following surgery
  • Have a CT scan performed (for the later measurement of disease volume by the core lab) within 90 days of the administration of study drug without any interventions between CT and iobenguane I 131 imaging.

All patients in Arm P and Arm C must also meet each of the following inclusion criteria:

  • Provide written informed consent and are willing to comply with protocol requirements
  • Are at least 18 years of age
  • If female, then not of childbearing potential as documented by history (e.g., tubal ligation or hysterectomy) or is post menopausal with a minimum 1 year without menses
  • If female of childbearing potential, has a negative serum HCG pregnancy test within 24 hours prior to receiving iobenguane I 131
  • If female of childbearing potential, agrees to use an acceptable form of birth control, defined as abstinence or use of IUD, oral contraceptive, barrier and spermicide, or hormonal implant, throughout the study period

Exclusion Criteria:

  • • Females who are nursing

    • Documented history of significant allergy that required medical intervention to shellfish, X-ray contrast media , iodine/iodides, or iobenguane
    • Administered a radioisotope within 5 effective half-lives of that radioisotope prior to study enrollment
    • Karnofsky performance status is < 60
    • Serum creatinine > 2.0 mg/dL
    • Total bilirubin > 1.5 times the upper limit of normal
    • AST/SGOT or ALT/SGPT > 3 times the upper limit of normal
    • Has received an investigational compound and/or medical device within 30 days before admission into this study
    • Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post dose follow-up examinations
    • Is determined by the Investigator that the patient is clinically unsuitable for the study
    • Has received a medication which inhibits uptake of iobenguane I 131 within 2 weeks prior to the administration of study drug. Patients must not have taken tricyclic antidepressants or related drugs within 6 weeks prior to enrollment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00339131

Sponsors and Collaborators
Molecular Insight Pharmaceuticals, Inc.
Investigators
Principal Investigator: Ralph E Coleman, MD Duke University
  More Information

No publications provided

Responsible Party: Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00339131     History of Changes
Other Study ID Numbers: MIP-IB11
Study First Received: June 17, 2006
Last Updated: October 7, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Molecular Insight Pharmaceuticals, Inc.:
radiopharmaceutical
radiation dosimetry
iodine
MIBG
iobenguane
Ultratrace
neuroendocrine tumors

Additional relevant MeSH terms:
Carcinoid Tumor
Paraganglioma
Pheochromocytoma
Adenocarcinoma
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
3-Iodobenzylguanidine
Antineoplastic Agents
Diagnostic Uses of Chemicals
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiopharmaceuticals
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014