Combination Targeted Radiotherapy in Neuroendocrine Tumors
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|ClinicalTrials.gov Identifier: NCT01099228|
Recruitment Status : Completed
First Posted : April 6, 2010
Last Update Posted : July 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Other: 131-I MIBG and 111-In pentetreotide Other: 131-I MIBG and In-111 DOTATATE||Not Applicable|
RESEARCH PLAN / BACKGROUND AND SIGNIFICANCE:
Tumors originating from the neuroendocrine system, although relatively rare, may be life threatening. In cases where the disease has metastasized, the 5 year survival is very poor. 131I meta-iodobenzylguanidine (MIBG)and 90Y DOTA-D-Phe1-Tyr3-Octreotide (DOTATOC) are two radiopharmaceuticals that have shown promise as therapeutic agents in patients with metastatic neuroendocrine tumors. However, delivering sufficient radiation dose to the tumor to obtain objective anti-tumor responses or cure with these radiopharmaceuticals is challenging because of the allowable dose limits imposed by radiation damage to normal tissues. Organ biodistribution and kinetics of 90Y DOTATOC and 131I MIBG are substantially different, which leads to different critical organs for these agents, the kidney for Y90Y DOTATOC and the red marrow for 131I MIBG. We propose to investigate a mechanism to increase the radiation dose delivered to tumors without exceeding "critical" radiation dose to normal organs by combining 90Y DOTATOC and 131I MIBG.
AIMS / OBJECTIVES:
The primary aim of this project is to determine, what fraction of individuals with neuroendocrine tumors would show substantially improved tumor dosimetry with combined agent therapy compared to "best" single agent therapy and determine the magnitude of the potential tumor radiation dose increase.
To achieve this, we plan to perform serial scintigraphic imaging procedures to measure patient specific bone marrow, kidney, and tumor biodistribution and kinetics for 111In Pentetreotide and 131I-MIBG in adults and children with neuroendocrine tumors. Then, using the program we have already developed, we will input the individual dosimetry measures for bone marrow, kidney and tumor to determine the optimal amounts of administered radioactivity for the combination of 131I MIBG plus 90Y DOTATOC or 131I MIBG alone.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combination Targeted Radiotherapy in Neuroendocrine Tumors|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||July 2015|
Active Comparator: 131-I MIBG and 111I-n pentetreotide
131-I MIBG and 111I-n pentetreotide
Other: 131-I MIBG and 111-In pentetreotide
Subjects will receive 131I MIBG and 111In pentetreotide(surrogate for Y90-DOTATOC)
Active Comparator: 131-I MIBG and In-111 DOTATATE
131-I MIBG and In-111 DOTATATE
Other: 131-I MIBG and In-111 DOTATATE
131I MIBG and In-111 DOTATATE (surrogate for 177Lu DOTATATE)
- Dosimetry Results [ Time Frame: 1 week after scan ]Determine the patient specific bone marrow, kidney and tumor dosimetry results for each subject from the 2 groups will be used to calculate the optimal combination of administered activities for 131I-MIBG plus 90Y-DOTATOC (group 1) 131I-MIBG plus 177Lu-DOTATATE (group 2) and the resultant dose delivery to tumor from each combination
- Maximum Radiation Dose [ Time Frame: 3 months ]Calculate the optimal amount for either agent when administered individually along with corresponding tumor radiation dose to determine the amount of each product will give maximum tumor kill and not damage other vunerable organs..
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): NCT01099228
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|Department of Veteran Affairs Medical Center|
|Iowa City, Iowa, United States, 52246|
|Principal Investigator:||David Bushnell, M.D.||University of Iowa; Veteran Affairs|