Phase-II Study of Lu177DOTATOC in Adults With STTR(+)Pulmonary, Pheochromocytoma, Paraganglioma, Unknown Primary, Thymus NETs (PUTNET), or Any Other Non-.GEP-NET.

Phase 2

Withdrawn

• Conditions: Pulmonary Neuroendocrine Neoplasm; Pheochromocytoma; Unknown Primary Tumors; Paraganglioma; Neuroendocrine Neoplasm of Ovary; Thymus Carcinoid; Neuroendocrine Carcinoma Metastatic; Neuroendocrine Tumors; Neuroendocrine Skin Carcinoma; Neuroendocrine Breast Tumor
• Interventions: Drug: 177Lu-DOTATOC

• Registration Number: NCT04276597
• Lead Sponsor: Excel Diagnostics and Nuclear Oncology Center

Brief Summary

Determine the safety and effectiveness of Lu-177 DOTATOC in adult subjects with somatostatin receptor-expressing Pulmonary, Pheochromocytoma, Paraganglioma, Unknown primary, and Thymus neuroendocrine tumors or any other non-.GEP-NET.

The treatment regimen will consist of 4 doses of 200 (±10%) mCi 177Lu-DOTATOC administered at 8+/- 1-week intervals.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-14
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-19
• Study Start: 2020-03-04
• Primary Completion: 2021-07-15
• Study Completion: 2021-07-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

• Known hypersensitivity to any of the excipients of Lu-177 DOTATOC.
• Therapeutic use of any somatostatin analogue, including Sandostatin® LAR (within 28 days) and Sandostatin® (within 1 day) prior to treatment.
• Subjects with unusual hematological parameters, including an increased MCV (>105fL), and especially in those who had previous chemotherapy, the advice of a hematologist should be sought for adequate further work-up
• Any subject who is taking concomitant medications that decrease renal function (such as aminoglycoside antibiotics).
• Female subjects who are pregnant, lactating or women of childbearing potential not willing to practice effective contraceptive techniques during the study period and for 67 days (more than 10 half-lives of 177Lu after the last treatment, or male subjects who have female partners of childbearing potential not willing to practice abstinence or effective contraception, during the study period and for 67 days after the last treatment.
• Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
• Indication for surgical lesion removal with curative potential
• Planned (for the period of study participation): chemotherapy, immunotherapy, radiation therapy (unless regional for pain relief) chemo-embolization, bland embolization, radio-embolization, treatment with cyclosporine-A.
• Known brain metastases; unless these metastases have been treated and stabilized 6 months prior to enrolment
• Completion of: (1) cytotoxic chemotherapy for less than 6 weeks; (2) a biological agent for less than 5 half-lives; and (3) radiation therapy (except regional for pain relief) for less than 6 weeks prior to study enrolment,
• Uncontrolled congestive heart failure; subjects suspected of having this condition need to show ejection fraction of > 35% as determined by MUGA scan.
• Glomerular Filtration Rate (GFR) < 35 mL/min
• Subjects with prior peptide receptor radionuclide therapy (PPRT).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lu177 DOTATOC treatment	177Lu-DOTATOC	4 doses of 200mCi 177Lu- DOTATOC PRRT

Primary Outcome Measures

Name	Time	Method
Assessment of the overall response rate	12 monts	determined using standard of care scans NETSPOT PET/CT, Octreoscan SPECT/CT, MRI

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (rPFS) in subjects receiving 4 cycles of therapy Monitoring of the changes in quality of life (QOL) through assessment of ECOG performance status and a QOL subject questionnaire.	12 months	determined using standard of care scans NETSPOT PET/CT, Octreoscan SPECT/CT, MRI

Trial Locations

Locations (1)

Excel Diagnostics and Nuclear Oncology Center; 🇺🇸 Houston, Texas, United States