Study of MIBG-I131 in Patients With Well Differentiated Neuroendocrine Tumors

NCT04831567 | Withdrawn Phase 2

• 1 other identifier: 3025/20
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroendocrine Tumors

Keywords

MIBG-I131; Nuclear medicine; Treatment

Outcome Measures

Primary Outcomes (2)

• Disease control rate (DCR) at 6 months after the end of treatment

  Defined by absence of radiological progression in conventional imaging examinations by RECIST 1.1.

  At 6 months after the end of MIBG-I131 (4 cycles - each cycle is 60 days)

• Quality of life measured by questionnaire

  Quality of life questionnaire (QLQ), assessed by the European Organisation for Research and Treatment of Cancer Quality of Life for Neuroendocrine Tumors (EORTC QLQ-GINET21) (score ranging from 0 to 100, with higher scores meaning better state of the patient). Improvement in at least 10% of the baseline score will be considered positive.

  At 6 months after the end of MIBG-I131 (4 cycles - each cycle is 60 days)

Secondary Outcomes (6)

• Disease control rate (DCR) at 3 months after the end of treatment

  At 3 months after the end of MIBG-I131 (4 cycles - each cycle is 60 days)

• Progression-free survival

  Trough study completion, an average of 3 years

• Radiological response rate

  Trough study completion, an average of 3 years

• Rate of Biochemical response

  Trough study completion, an average of 3 years

• Quality of life measured by questionnaires

  Trough study completion, an average of 3 years

Study Arms (1)

Interventional

EXPERIMENTAL

The participants will be submitted to metaiodobenzylguanidine 4 doses of 7.400 Mbq (million of Becquerels) (200 mCi). Each dose will be repeated with a minimum interval of 60 days.

Radiation: MIBG-I131

Interventions

MIBG-I131 RADIATION

Radiopharmaceutical

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AC Camargo Cancer Center: lead

Study Sites (1)

AC Camargo Cancer Center

São Paulo, São Paulo, 01509010, Brazil

Location

Related Publications (14)

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• van Hulsteijn LT, Niemeijer ND, Dekkers OM, Corssmit EP. (131)I-MIBG therapy for malignant paraganglioma and phaeochromocytoma: systematic review and meta-analysis. Clin Endocrinol (Oxf). 2014 Apr;80(4):487-501. doi: 10.1111/cen.12341. Epub 2013 Nov 19.

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• Ezziddin S, Logvinski T, Yong-Hing C, Ahmadzadehfar H, Fischer HP, Palmedo H, Bucerius J, Reinhardt MJ, Biersack HJ. Factors predicting tracer uptake in somatostatin receptor and MIBG scintigraphy of metastatic gastroenteropancreatic neuroendocrine tumors. J Nucl Med. 2006 Feb;47(2):223-33.

  PMID: 16455627 BACKGROUND

• Riechelmann RP, Pereira AA, Rego JF, Costa FP. Refractory carcinoid syndrome: a review of treatment options. Ther Adv Med Oncol. 2017 Feb;9(2):127-137. doi: 10.1177/1758834016675803. Epub 2016 Nov 2.

  PMID: 28203303 BACKGROUND

• Kane A, Thorpe MP, Morse MA, Howard BA, Oldan JD, Zhu J, Wong TZ, Petry NA, Reiman R Jr, Borges-Neto S. Predictors of Survival in 211 Patients with Stage IV Pulmonary and Gastroenteropancreatic MIBG-Positive Neuroendocrine Tumors Treated with 131I-MIBG. J Nucl Med. 2018 Nov;59(11):1708-1713. doi: 10.2967/jnumed.117.202150. Epub 2018 May 18.

  PMID: 29777005 BACKGROUND

• Mulholland N, Chakravartty R, Devlin L, Kalogianni E, Corcoran B, Vivian G. Long-term outcomes of (131)Iodine mIBG therapy in metastatic gastrointestinal pancreatic neuroendocrine tumours: single administration predicts non-responders. Eur J Nucl Med Mol Imaging. 2015 Dec;42(13):2002-12. doi: 10.1007/s00259-015-3116-4. Epub 2015 Jul 5.

  PMID: 26142730 BACKGROUND

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  PMID: 26703889 BACKGROUND

Related Links

• EORTC Quality of Life Questionnaire - QLQ-GINET21

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

3-Iodobenzylguanidine

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Iodobenzenes; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Hydrocarbons, Iodinated; Hydrocarbons, Halogenated

Study Officials

• Rachel SP Riechelmann, Phd

  AC Camargo Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Medical Oncology Department

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: April 5, 2021
• Study Start: February 4, 2021
• Primary Completion: May 13, 2022
• Study Completion: May 13, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)