Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04831567
Status:
WITHDRAWN
Last Update Posted:
2022-05-19
First Post:
2021-03-25
Brief Title:
Study of MIBG-I131 in Patients With Well Differentiated Neuroendocrine Tumors
Sponsor:
AC Camargo Cancer Center
Organization:
AC Camargo Cancer Center
Study Overview
Official Title:
Phase II Study of MIBG-I131 Metaiodobenzylguanidine in Patients With Well Differentiated Neuroendocrine Tumors and MIBG Positive Scan
Status:
WITHDRAWN
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No participants enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIBNET
Brief Summary:
This is a single-arm unicentric single-stage phase 2 clinical study of therapeutic metaiodobenzylguanidine MIBG for patients with metastatic well-differentiated neuroendocrine tumors and radiological progression or intolerance after standard lines of treatment and with MIBG positive scan
Detailed Description:
Neuroendocrine tumors NET are rare neoplasms which frequently present metastatic and incurable at diagnosis In this context few effective therapies exist When the disease becomes refractory to standard therapies treatments with limited efficacy eg surgical debulking cytotoxic chemotherapies interferon alpha that could lead to important adverse events are used Therefore clinical studies that test new therapeutic strategies in NET patients with refractory disease are needed Treatment with radiopharmaceuticals have been studied in NET and showed to be promisor As an example is the treatment with Lutetium177 octreotate disponible in Brazil for decades and one of the most active therapeutic options to NET
The radiopharmaceutical MIBG-I131 metaiodobenzylguanidine linked to Iodine131 is the first treatment choice for patients with paragangliomapheochromocytoma PggF a rare type of neuroendocrine neoplasm originated from neural ganglia Patients with this neoplasia are submitted to scintigraphy with MIBG-I131 a norepinephrine analog whose transporter protein is highly expressed in this tumor If the uptake is positive patients receive treatment with therapeutic doses of MIBG-I131 The disease control with this intervention could last two years Old and small studies suggested that MIBG-I131 could also have an activity in other NET besides PggF Gastrointestinal GI or lung NET could have a positive expression on MIBG-I131 scan in up to 50 of the cases With this rationale retrospective series reported that MIBG-I131 could offer clinical benefit in patients with GI NET with disease control in up to 80 of the cases However the literature regarding therapeutic MIBG-I131 to NET not PggF is scarce heterogeneous regarding population methods of response assessment doses of the radiopharmaceutical and short follow-up time Therefore due to the absence of effective therapeutic options for patients with metastatic well-differentiated NET refractory to standard treatments the evidence that NET can have a positive expression on MIBG-I131 scan and that small retrospective studies with a low level of evidence suggest a benefit for control disease and improvement of symptoms the investigators proposed a phase II study of MIBG-I131 to well-differentiated GI or lung NET patients with positive MIBG-I131 scan
The radiopharmaceutical MIBG-I131 metaiodobenzylguanidine linked to Iodine131 is the first treatment choice for patients with paragangliomapheochromocytoma PggF a rare type of neuroendocrine neoplasm originated from neural ganglia Patients with this neoplasia are submitted to scintigraphy with MIBG-I131 a norepinephrine analog whose transporter protein is highly expressed in this tumor If the uptake is positive patients receive treatment with therapeutic doses of MIBG-I131 The disease control with this intervention could last two years Old and small studies suggested that MIBG-I131 could also have an activity in other NET besides PggF Gastrointestinal GI or lung NET could have a positive expression on MIBG-I131 scan in up to 50 of the cases With this rationale retrospective series reported that MIBG-I131 could offer clinical benefit in patients with GI NET with disease control in up to 80 of the cases However the literature regarding therapeutic MIBG-I131 to NET not PggF is scarce heterogeneous regarding population methods of response assessment doses of the radiopharmaceutical and short follow-up time Therefore due to the absence of effective therapeutic options for patients with metastatic well-differentiated NET refractory to standard treatments the evidence that NET can have a positive expression on MIBG-I131 scan and that small retrospective studies with a low level of evidence suggest a benefit for control disease and improvement of symptoms the investigators proposed a phase II study of MIBG-I131 to well-differentiated GI or lung NET patients with positive MIBG-I131 scan
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None