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Phase 1 Study of Iobenguane (MIBG) I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00458952
First received: April 9, 2007
Last updated: June 13, 2016
Last verified: June 2016

April 9, 2007
June 13, 2016
April 2007
June 2009   (final data collection date for primary outcome measure)
MTD of Ultratrace Iobenguane I 131 [ Time Frame: 6 weeks post therapy dose ] [ Designated as safety issue: Yes ]
Although no primary efficacy endpoint was defined for this study, the MTD of Ultratrace iobenguane I 131 in patients with malignant pheochromocytoma/paraganglioma (a safety rather than an efficacy parameter) is the primary objective.
  • Phase1: Toxicities (DLTs) in 1st 6 Weeks After Therapeutic (tx) Dose
  • Phase2: tumor response by CT/MRI 9 months after tx dose
Complete list of historical versions of study NCT00458952 on ClinicalTrials.gov Archive Site
Not Provided
  • Phase1: radiation absorbed 1 hour after dose 1(small dose), 2-4 days after dose 1, and 5-7 days after dose 1; tumor response by CT/MRI & blood/urine tests 3, 6, 9, & 12 months after tx dose; dose response by CT/MRI 9 months after tx dose
  • Phase2: tumor response by CT/MRI & blood/urine tests 3, 6, 9, & 12 month after tx dose; quality of life 3, 6, 9, & 12 months after tx dose
Not Provided
Not Provided
 
Phase 1 Study of Iobenguane (MIBG) I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma
A Phase I Study Evaluating the Maximum Tolerated Dose, Dosimetry, Safety, and Efficacy of Ultratrace Iobenguane I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma
The purpose of this study is to determine whether iobenguane I 131 is safe and effective in patients with malignant pheochromocytoma or paraganglioma.
This was originally designed as a phase 1/2 study. The phase 1 patients received a small dose of study drug to see if the tumors absorb the drug. If the patient's tumors absorbed the drug, then the patient received one therapeutic dose. In the phase 1 portion, the study employed a 3 + 3 dose escalation design. Enrollment in the phase 1 portion was to be completed once researches believed that they found the highest dose that they could give patients without causing unacceptable toxicity. This dose is called the maximum tolerated dose (MTD). Following discussions with the Food and Drug Administration (FDA) that occurred during the dose escalation stage of the study, the protocol was amended to conclude the trial upon the identification of the MTD. The Phase 2 safety/ efficacy stage of the study was conducted with modifications of the primary endpoint as Protocol MIP IB12B, with Special Protocol Assessment Agreement with the FDA in March 2009.
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pheochromocytoma
  • Paraganglioma
Drug: Ultratrace Iobenguane (MIBG) I 131
Phase I: Dose escalation protocol Phase II: Treatment schedule at therapeutic dose
Other Names:
  • Ultratrace Iobenguane I 131
  • Azedra Ultratrace (iobenguane I 131)
Experimental: Dose Escalation
Dosing of Ultratrace iobenguane I 131 began at 6.0 mCi/kg and escalated in 1.0 mCi/kg increments in order to establish the MTD. The MTD is the dose immediately below the level at which escalation stops due to dose-limiting toxicity (DLT). An additional 3 patients are to be treated at the MTD, for a total of 6.
Intervention: Drug: Ultratrace Iobenguane (MIBG) I 131
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2011
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have a diagnosis of either adrenal pheochromocytoma or extra-adrenal paraganglioma by histological confirmation OR plasma-free metanephrines and 24-hour urine test for catecholamines/ metanephrines
  • Disease is metastatic or has recurred following surgery
  • At least one measurable lesion seen by computed tomography (CT) or magnetic resonance (MR) scan performed within 4 weeks prior to the first dose of study drug
  • At least one known tumor site is also seen on Ultratrace iobenguane I 131 scan
  • 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 b-HCG pregnancy test within 48 hours prior to receiving iobenguane I 131
  • Females who agree not to become pregnant and males who agree not to father a child during the 1 year period following the therapeutic dose of Ultratrace iobenguane I 131. Both females and males must use an acceptable method of birth control during the first year following the therapeutic dose of Ultratrace iobenguane I 131.

Exclusion Criteria:

  • Females who are nursing
  • Active CNS lesions by CT/MR scanning within 3 months of study entry
  • New York Heart Association class III-IV heart failure
  • Received any previous systemic radiotherapy within 6 months of study entry
  • Administered prior whole-body radiation therapy
  • Received external beam radiotherapy to greater than 25 percent of bone marrow
  • Administered prior chemotherapy within 30 days of study entry
  • Karnofsky performance status is less than 60
  • Platelets are less than 100,000/uL
  • Absolute neutrophil count (ANC) is less than 1,500/uL
  • Serum creatinine is greater than 1.5 mg/dL
  • Total bilirubin is greater than 1.5 times the upper limit of normal
  • AST/SGOT or ALT/SGPT is greater than 2.5 times the upper limit of normal
  • Has received a therapeutic 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:
  • phenothiazines or decongestants within 2 weeks prior to enrollment; or,
  • a tricyclic antidepressant within 6 weeks prior to enrollment.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
Canada
 
NCT00458952
MIP-IB12
No
Not Provided
Not Provided
Molecular Insight Pharmaceuticals, Inc.
Molecular Insight Pharmaceuticals, Inc.
Not Provided
Study Director: Molecular Insight Pharmaceuticals MIP
Molecular Insight Pharmaceuticals, Inc.
June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP