Phase 1-2 Study of Iobenguane (MIBG) I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma
Information source: Molecular Insight Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pheochromocytoma; Paraganglioma
Intervention: Ultratrace Iobenguane (MIBG) I 131 (Drug)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: Molecular Insight Pharmaceuticals, Inc. Official(s) and/or principal investigator(s): Norman LaFrance, MD, Study Director, Affiliation: Molecular Insight Pharmaceuticals
Summary
The purpose of this study is to determine whether iobenguane I 131 is safe and effective in
patients with malignant pheochromocytoma or paraganglioma.
Clinical Details
Official title: A Phase I-II Study Evaluating the Maximum Tolerated Dose, Dosimetry, Safety, and Efficacy of Ultratrace Iobenguane I 131 in Patients With Malignant Pheochromocytoma/Paraganglioma
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Phase1: toxicities (DLTs) in 1st 6 weeks after therapeutic (tx) dosePhase2: tumor response by CT/MRI 9 months after tx dose
Secondary outcome: 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 dosePhase2: 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
Detailed description:
This is a phase 1 and phase 2 study. The phase 1 patients will be enrolled before the phase
2 patients are enrolled. Each patient will receive a small dose to see if the tumors absorb
the drug. If the patient's tumors absorb the drug, then the patient will receive one
therapeutic dose. In the phase 1 portion, every 3 patients will be given the same
therapeutic dose, and usually each group of 3 patients will be given a larger dose than
people who were enrolled before them. Enrollment in the phase 1 portion will be complete
once researches believe that they have found the highest dose that they can give patients
without causing unacceptable toxicity. This dose is called the maximum tolerated dose (MTD).
All phase 2 patients will receive the MTD. Each patient in phase 1 and phase 2 will be
followed for 5 years following their therapeutic dose. During this 5-year follow-up period,
patients will undergo tests such as 1.) CT or MRI scans and blood and urine tests to
determine if the tumors shrink, grow, or stay the same; 2.) bone scans to see if the tumor
has spread to or increased in the bones and, 3.) a quality of life test to see how the
symptoms of pheochromocytoma or paraganglioma affect patients' daily lives.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Cross Cancer Institute, Edmonton, Alberta T6G 2N8, Canada
University of Iowa Medical Center, Iowa City, Iowa 52242, United States
Johns Hopkins University, Baltimore, Maryland 21287-0817, United States
Mayo Clinic, Rochester, Minnesota 55905, United States
Mallinckrodt Institute of Radiology, St. Louis, Missouri 63110, United States
Mount Sinai School of Medicine, New York, New York 10029, United States
New York Presbyterian Hospital-Weill Cornell Medical Center, New York, New York 10021, United States
Duke University Medical Center, Durham, North Carolina 27710, United States
London Health Sciences Centre, London, Ontario N6A 5W9, Canada
Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Rhode Island Hospital, Providence, Rhode Island 02903, United States
Additional Information
Starting date: April 2007
Last updated: August 1, 2012
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