A Study Evaluating Ultratrace Iobenguane I 131(MIBG)in Patients With Malignant Pheochromocytoma/Paraganglioma
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Purpose
This clinical trial is designed to evaluate the effectiveness and collect additional safety information on Ultratrace Iobenguane I 131 for the treatment of relapsed/refractory (to other treatment) malignant pheochromocytoma and paraganglioma.
The purpose of this trial is to test the use of Ultratrace iobenguane I 131 as a treatment for pheochromocytoma and paraganglioma type cancer. 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 therapy doses that are given 3 months apart.
| Condition | Intervention | Phase |
|---|---|---|
|
Pheochromocytoma Paraganglioma |
Radiation: Ultratrace Iobenguane I131 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study Evaluating the Efficacy and Safety of Ultratrace Iobenguane I 131 in Patients With Malignant Relapsed/Refractory Pheochromocytoma/Paraganglioma |
- Proportion of study subjects with a reduction (including discontinuation) of all antihypertensive medication by at least 50% for at least six months or two cycles Ultratrace Iobenguane I 131. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
- Proportion of subjects with overall tumor response of Complete Response or Partial Response by RECIST criteria [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
- Safety assessed by changes in lab values, physical exams or vital signs, and the occurrence of treatment emergent adverse events [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 75 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2015 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Ultratrace Iobenguane I 131 Treatment |
Radiation: Ultratrace Iobenguane I131
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.
Other Name: Azedra
|
Detailed Description:
Azedra™ Ultratrace™ (Iobenguane I 131), commonly referred to as Ultratrace Iobenguane I 131, is a very high specific activity form of iobenguane I 131, produced using Molecular Insight's proprietary Ultratrace™ platform. Based on the well characterized cellular active transport mechanism, the higher the specific activity of iobenguane I 131, the greater the cellular uptake of radioactivity and hence greater tumor uptake.
During this study the subjects will receive two (2) Therapy Doses that are given three (3) months apart. Prior to administration of the first Therapy Dose, subjects will be given an Imaging Dose of Ultratrace Iobenguane I 131 and will undergo iobenguane I 131 scans to evaluate tumor uptake and to measure normal organ distribution and allow for the calculation of radiation dose to normal organs.
Screening procedures for eligibility will need to be done before imaging or therapeutic doses of Iobenguane I 131 are administered.
Hospitalization is required for approximately one (1) week after each of the two (2) Therapeutic Doses. Frequent follow up is necessary for the first year and some of the follow up visits may be done by a visiting health care professional in the subjects' homes. Subjects will be followed in the treatment study for one (1) year and for an additional four (4) years in long-term follow up.
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Be at least 12 years of age
- Have a documented (medical record) diagnosis of either pheochromocytoma or paraganglioma with histological confirmation
- 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.
Exclusion Criteria:
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
- Known allergy to iobenguane that has required medical intervention
- Received a therapeutic investigational compound and/or medical device/prior chemotherapy within 30 days before admission into this study
- Receiving a medication which inhibits tumor uptake of iobenguane I 131
- Any medical condition or other circumstances (i.e., uncontrolled current illness including but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with the study requirements.
- Any other condition, that in the opinion of the investigator, may compromise the safety or compliance of the subject or would preclude the subject from successful completion of the study
Contacts and Locations| United States, California | |
| University of California-San Francisco | |
| San Francisco, California, United States, 94143 | |
| United States, Florida | |
| University of Miami Miller School of Medicine | |
| Miami, Florida, United States, 33136 | |
| United States, Iowa | |
| University of Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Louisiana | |
| Louisana State University Health Sciences Center | |
| Kenner, Louisiana, United States, 70065 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Missouri | |
| Washington University School of Medicine, Alvin J. Siteman Cancer Center | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Edward Coleman, MD | Duke University |
| Principal Investigator: | Lowell Anthony, MD | Louisana State University Health Center |
| Principal Investigator: | Daniel Pryma, MD | University of Pennsylvania |
| Principal Investigator: | Perry W Grigsby, MD | Mallinckrodt Institute of Radiology Washington University |
| Principal Investigator: | Camillo Jimenez, MD | MD Anderson Cancer |
| Principal Investigator: | Richard Noto, MD | Rhode Island Hospital |
| Principal Investigator: | Thomas O'Dorisio, MD | University of Iowa |
| Principal Investigator: | Richard Wahl, MD | Johns Hopkins University |
| Principal Investigator: | Lale Kostakoglu, MD | Mount Sinai School of Medicine |
| Principal Investigator: | Aldo Serafini, MD | University of Miami |
| Principal Investigator: | Miguel Pampaloni, MD PhD | University of California, San Francisco |
More Information
No publications provided
| Responsible Party: | Molecular Insight Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00874614 History of Changes |
| Other Study ID Numbers: | MIP-IB12B |
| Study First Received: | April 1, 2009 |
| Last Updated: | August 1, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Molecular Insight Pharmaceuticals, Inc.:
|
radiotherapy MIBG Azedra neuroendocrine tumors |
paraganglioma pheochromocytoma Iobenguane I 131 |
Additional relevant MeSH terms:
|
Paraganglioma Pheochromocytoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue 3-Iodobenzylguanidine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013