A Study Evaluating Ultratrace Iobenguane I131 in Patients With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma

NCT00874614 | Unknown Phase 2 Results DMC

• 1 other identifier: MIP-IB12B
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 10

Brief Summary

This clinical trial is designed to evaluate the effectiveness and collect additional safety information on AZEDRA® (iobenguane I 131) for the treatment of metastatic or relapsed/refractory (to other treatment) or unresectable pheochromocytoma or paraganglioma. The purpose of this trial is to test the use of AZEDRA® as a treatment for pheochromocytoma and paraganglioma, a rare disease. This Phase II study will help determine primarily if using the drug reduces the amount of blood pressure medication being taken as a result of the cancer and secondarily to determine such things as the effectiveness of the study drug in treating the cancer, additional safety measures, and to assess if the drug helps the quality of life and use of pain medication. All subjects will receive an imaging dose with scans followed by two therapeutic doses given approximately 3 months apart.

Conditions

Pheochromocytoma; Paraganglioma

Keywords

radiotherapy; MIBG; Azedra; neuroendocrine tumors; Iobenguane I 131; progenics

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Who Experienced a 50% or Greater Reduction (Including Discontinuation) of All Antihypertensive Medication(s) Lasting for at Least Six Months.

  12 months

Secondary Outcomes (3)

• Best Confirmed Overall Tumor Response of Complete Response (CR) or Partial Response (PR) by RECIST 1.0.

  12 months

• Changes From Baseline in Overall Quality of Life (QoL) - Best Response Within 12 Months After First Therapeutic Dose of AZEDRA®.

  12 Months

• Overall Survival

  Up to 5 Years (60 months)

Study Arms (1)

Ultratrace® Iobenguane I 131 Treatment

EXPERIMENTAL

Radiation: Ultratrace® Iobenguane I131

Interventions

Ultratrace® Iobenguane I131 RADIATION

Each subject will be administered 3 mCi to 6 mCi Ultratrace® Iobenguane I 131, referred to as the Imaging Dose, to confirm that subject meets radiological entry criteria and to establish dosimetry. All subjects meeting entry criteria will then receive the investigational product referred to as the Therapeutic Dose (500 mCi or 8 mCi/kg if the subject weighs 62.5 kg or less) of Ultratrace Iobenguane I 131, followed by imaging at 7 days post infusion or upon discharge from isolation. The Therapeutic Doses will be adjusted equally if warranted by results of the dosimetry evaluation. At least 3 months later, subjects will receive the second Therapeutic Dose.

Also known as: Azedra®, MIBG

Ultratrace® Iobenguane I 131 Treatment

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 12 years of age
• Have a documented (medical record) diagnosis of either pheochromocytoma or paraganglioma
• Be ineligible for curative surgery for pheochromocytoma
• Have failed a prior therapy for pheochromocytoma/paraganglioma or are not candidates for chemotherapy or other curative therapies
• Be on stable antihypertensive medication for pheochromocytoma-related hypertension for at least 30 days
• Have at least one tumor site by CT or MR or iobenguane I 131 scan
• Have an expected survival of at least 6 months
• Subjects must agree to use an acceptable form of birth control (abstinence, IUD, oral contraception, barrier and spermicide or hormonal implant) during this study and for 6 months following Therapeutic Doses of Ultratrace Iobenguane I 131.
• Male subjects must agree not to father a child during the period beginning immediately after administration of the first Therapeutic Dose of Ultratrace Iobenguane I 131 during the study and ending six months after administration of the last Therapeutic Dose of Ultratrace Iobenguane I 131.

You may not qualify if:

• Subjects will be excluded if any of the following conditions are observed:
• \<50% of FDG (if data are available) positive lesions are MIBG avid
• Pregnant or nursing females
• Active CNS lesions by CT/MR scanning within 3 months of study entry
• New York Heart Association class IV heart failure, symptomatic congestive heart failure \[New York Heart Association class IV with another medical disorder\], unstable angina pectoris, cardiac arrhythmia
• Received any previous systemic radiotherapy resulting in marrow toxicity within 3 months of study entry or have active malignancy (other than pheochromocytoma/paraganglioma) requiring additional treatment during the active phase or follow up period of the Ultratrace® iobenguane I 131 trial.
• Administered prior whole-body radiation therapy
• Received external beam radiotherapy to \> 25% of bone marrow
• Administered prior chemotherapy within 30 days or have active malignancy (other than pheochromocytoma/ paraganglioma) requiring additional treatment during the active phase or follow up period of the Ultratrace iobenguane I 131 trial.
• Karnofsky Performance Status is \< 60
• Platelets \< 80,000/μL
• Absolute neutrophil count (ANC) \< 1,200/μL, Total bilirubin \> 1.5 times the upper limit of normal, AST/SGOT or ALT/SGPT \> 2.5 times the upper limit of normal
• Diagnosed with AIDS or HIV-positive
• Active chronic alcohol abuse, chronic liver disease or hepatitis
• Renal dysfunction/impairment

Sponsors & Collaborators

• Molecular Insight Pharmaceuticals, Inc.: lead

Study Sites (10)

University of California-San Francisco

San Francisco, California, 94143, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Washington University School of Medicine, Alvin J. Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Jimenez C, Chin BB, Noto RB, Dillon JS, Solnes L, Stambler N, DiPippo VA, Pryma DA. Biomarker response to high-specific-activity I-131 meta-iodobenzylguanidine in pheochromocytoma/paraganglioma. Endocr Relat Cancer. 2023 Jan 5;30(2):e220236. doi: 10.1530/ERC-22-0236. Print 2023 Feb 1.

  PMID: 36472300 DERIVED

MeSH Terms

Conditions

Pheochromocytoma; Paraganglioma; Neuroendocrine Tumors

Interventions

3-Iodobenzylguanidine

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Iodobenzenes; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hydrocarbons, Iodinated; Hydrocarbons, Halogenated

Results Point of Contact

• Title: Jessica D Jensen, MPH
• Organization: Progenics Pharmaceuticals, Inc

jjensen@progenics.com

646-975-2513

Study Officials

• Bennett Chin, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Daniel Pryma, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Jeffrey Olsen, MD

  Mallinckrodt Institute of Radiology Washington University

  PRINCIPAL INVESTIGATOR

• Camillo Jimenez, MD

  MD Anderson Cancer

  PRINCIPAL INVESTIGATOR

• Joseph Dillon, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Lilja Solnes, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Lale Kostakoglu, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Michael H Pampaloni, MD

  University of California at San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 2, 2009
• Study Start: June 4, 2009
• Primary Completion: February 14, 2017
• Study Completion: February 1, 2021
• Last Updated: February 20, 2020
• Results First Posted: October 5, 2018

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)