Status:
WITHDRAWN
Study of MIBG-I131 in Patients With Well Differentiated Neuroendocrine Tumors
Lead Sponsor:
AC Camargo Cancer Center
Conditions:
Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 radiolog...
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 s...
Eligibility Criteria
Inclusion
- Age greater than or equal to 18 years
- Histological diagnosis of well-differentiated neuroendocrine tumor (NET) (typical and atypical lung carcinoids and NET of all gastroenteropancreatic sites according to World Health Organization (WHO) 2019 classification); metastatic/unresectable, with no possibility of curative treatment.
- MIBG-I131 positive scan in at least one lesion with uptake compatible with therapeutic effectiveness.
- Disease with radiological progression (at least 10 percent tumor volume growth) in the last 12 months before day 1 cycle 1.
- Intolerance due to toxicities or lack of access to standard treatments - \[private context (somatostatin analog, everolimus) and public health system (somatostatin analog)\].
- Measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance scale 0 to 2.
- Adequate organic function as defined by the following criteria:
- serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal of the local laboratory (ULN-LL);
- Total serum bilirubin ≤ 2.0 x ULN-LL;
- Absolute neutrophil count ≥ 1,500 / mm\^3;
- Platelet count ≥ 100,000 / mm\^3;
- Hemoglobin ≥ 9.0 g / dL;
- Estimated creatinine clearance by the Modification of Diet in Renal Disease (MDRD) equation ≥ 60ml / min
- Term of free and informed consent signed by the patient or legal representative.
Exclusion
- Patients already treated with MIBG-I131.
- A history of serious clinical or psychiatric illness that, by clinical judgment, may involve participation risk in this study.
- Patients participating in other protocols with experimental drugs.
- Patients who underwent major recent surgery less than 4 weeks previously.
- Patients receiving chemotherapy or other oncologic therapy for less than 3 weeks.
- Pregnant or lactating patients.
- Another synchronous neoplasm that requires systemic treatment.
Key Trial Info
Start Date :
February 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 13 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04831567
Start Date
February 4 2021
End Date
May 13 2022
Last Update
May 19 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
AC Camargo Cancer Center
São Paulo, São Paulo, Brazil, 01509010