A Phase II Study of 131I- Metaiodobenzylguanidine (MIBG) for Treatment of Metastatic or Unresectable Pheochromocytoma and Related Tumors
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|ClinicalTrials.gov Identifier: NCT01413503|
Recruitment Status : Completed
First Posted : August 10, 2011
Results First Posted : September 18, 2018
Last Update Posted : September 18, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pheochromocytoma Paraganglioma||Radiation: 131I-MIBG||Phase 2|
- To assess the efficacy of high-dose 131I-MIBG in the treatment of patients with malignant pheochromocytoma and related tumors, with the basis of this initial examination being the percentage of patients in CR or PR, and the percentage of patients without PD for 3 years after the initial administration on 131I-MIBG therapy.
- To describe the response rate of malignant pheochromocytoma patients treated with high-dose 131I-MIBG.
- To describe the toxicity of high-dose 131I-MIBG in patients with malignant pheochromocytoma.
- To describe the overall survival and failure-free survival of malignant pheochromocytoma patients treated with high-dose 131I-MIBG.
- To determine the utility of using the serum level of Chromogranin A as a tumor marker for patients with malignant pheochromocytoma.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of 131I-labeled Metaiodobenzylguanidine (MIBG) for Treatment of Patients With Metastatic or Unresectable Pheochromocytoma and Related Tumors|
|Study Start Date :||May 1991|
|Actual Primary Completion Date :||September 6, 2007|
|Actual Study Completion Date :||May 2009|
Patients received 131I-MIBG 8-12 mCi/kg (maximum 500 mCi ± 10% at investigator's discretion) diluted in 25 ml of normal saline. Patients were infused intravenously through a patient's peripheral or central line over 120 minutes
Therapeutic 131I-MIBG will be synthesized at Nuclear Diagnostic Products (NDP; Rockaway, New Jersey) with specific activities of 9-18 Ci/mmole. The therapeutic dose: 8-12 mCi/kg (maximum 1200 mCi ± 10% at investigator's discretion) will be diluted in 25 ml of normal saline, and will be infused intravenously through a patient's peripheral or central line over 120 minutes. The patient will remain in a radiation protected isolation room until radiation emissions are ≤ 2 mr/hr at a 1 meter distance or meets institutional and state guidelines. This usually takes 4-6 days. In all cases, special shielding will be equipped in the room to minimize exposure to the outside environment and personnel will observe institutional radiation safety precautions.
Other Name: MIBG
- Number of Patients With Complete (CR), Partial (PR), or Minor (MR) Response and Without Progressive Disease [ Time Frame: After 1 year from initial treatment ]Patients with complete (CR), partial (PR), or minor (MR) response and without progressive disease 1 year from initial treatment, using RECIST RESPONSE CRITERIA for measurable soft tissue tumor: CR=No Tumor (Primary or metastatic); catacholamines, metanephrines and chromogranin A all normal. PR=Primary and all measurable sites decreased >50%; number of positive bone sites decreased by >50%; bone marrow tumor decreased by 50%. MR=No new lesions; >50% reduction of any measurable lesion (primary or metastases); <25% increase in any existing lesion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413503
|United States, California|
|San Francisco, California, United States, 94103|
|Principal Investigator:||Paul Fitzgerald||UCSF School of Medicine|