NCT00458952

Brief Summary

The purpose of this study is to determine whether iobenguane I 131 is safe and effective in patients with malignant pheochromocytoma or paraganglioma.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

April 20, 2016

Completed
Last Updated

July 13, 2016

Status Verified

June 1, 2016

Enrollment Period

2.2 years

First QC Date

April 9, 2007

Results QC Date

December 15, 2015

Last Update Submit

June 13, 2016

Conditions

PheochromocytomaParaganglioma

Keywords

MIBGiobenguaneiodineI 131radiotherapyradiopharmaceuticaldosimetryneuroendocrine tumorUltratraceno carrier addedmetaiodobenzyl-guanidine

Outcome Measures

Primary Outcomes (1)

  • MTD of Ultratrace Iobenguane I 131

    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.

    6 weeks post therapy dose

Study Arms (1)

Dose Escalation

EXPERIMENTAL

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.

Drug: Ultratrace Iobenguane (MIBG) I 131

Interventions

Ultratrace Iobenguane (MIBG) I 131DRUG

Phase I: Dose escalation protocol Phase II: Treatment schedule at therapeutic dose

Also known as: Ultratrace Iobenguane I 131, Azedra Ultratrace (iobenguane I 131)
Dose Escalation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

New York Presbyterian Hospital-Weill Cornell Medical Center

New York, New York, 10021, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Related Publications (1)

  • Noto RB, Pryma DA, Jensen J, Lin T, Stambler N, Strack T, Wong V, Goldsmith SJ. Phase 1 Study of High-Specific-Activity I-131 MIBG for Metastatic and/or Recurrent Pheochromocytoma or Paraganglioma. J Clin Endocrinol Metab. 2018 Jan 1;103(1):213-220. doi: 10.1210/jc.2017-02030.

    PMID: 29099942DERIVED

MeSH Terms

Conditions

PheochromocytomaParagangliomaNeuroendocrine Tumors

Interventions

3-IodobenzylguanidineIodine-131

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsIodobenzenesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsHydrocarbons, IodinatedHydrocarbons, Halogenated

Results Point of Contact

Title
Senior Director, Clinical Science Communications
Organization
Progenics Pharmaceuticals, Inc.
vdipippo@progenics.com
914 784-1825

Study Officials

  • Molecular Insight Pharmaceuticals

    MIP

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2007

First Posted

April 11, 2007

Study Start

April 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2011

Last Updated

July 13, 2016

Results First Posted

April 20, 2016

Record last verified: 2016-06

Locations

US(3)