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

March 9, 2023 updated by: Excel Diagnostics and Nuclear Oncology Center

A Phase II, Non-Randomized, Open-Label, Single-center, Physician Sponsored Study to Determine the Safety and Effectiveness of Lu-177 DOTATOC in Adult Subjects With Somatostatin Receptor Expressing Pulmonary, Pheochromocytoma, paragangliomUnknown Primary, and Thymus Neuroendocrine Tumors (PUTNET) or Any Other Non-.GEP-NET.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77042
        • Excel Diagnostics and Nuclear Oncology Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Signed informed consent.
  • Subjects of either sex, aged ≥18 years.
  • ECOG status 0-2.
  • Life-expectancy of at least 12 weeks.
  • Histologically/cytologically confirmed diagnosis of SSTR (+) neuroendocrine tumors of the lung, Pheochromocytoma, Paraganglioma, thymus, and unknown primary, unresectable or metastatic.
  • Measurable disease per RECIST 1.1, on CT/MRI scans, defined as at least 1 lesion with ≥ 1 cm in longest diameter (lymph nodes along short axis >15 mm).
  • Appropriate diagnostic imaging studies, at the discretion of the P.I. including but not limited to CT, MRI , 18F-FDG PET/CT, NAF PET/CT bone scan, ultrasound, etc. of the tumor region or suspected area within the 4 weeks of dosing day.
  • Somatostatin receptor positive (SSTR+) disease, as evidenced by available FDA, commercially of IND approved SSTR imaging (SRI), within 4 weeks prior to the first cycle
  • Recent blood test results (within 2weeks pre-dose) as follows:
  • Sufficient bone marrow capacity as defined by WBC ≥2,500/µl and WBC≥2,000/mm3 for subsequent cycles; platelets ≥ 100,000 (100 * 103/mm3) for the first treatment and ≥75,000 for the subsequent therapies, Hgb ≥8.9 g/dl for the first treatment and 8.0 g/dl for the subsequent therapies, ANC ≥1500/mm3 for the first treatment and ≥1000/ mm3; for the subsequent therapies.
  • ALT, AST values ≤3 times ULN
  • Bilirubin: ≤3 times ULN
  • Serum creatinine ≤ 150 µmol/liter or 1.7 mg/dl
  • Negative pregnancy test in women capable of child-bearing within 48 hours of IMP administration.
  • Serum albumin > 3.0g/L (<3 g/L may be acceptable at the discretion of investigator, if PT, PTT, and INR are within normal range)
  • All available FDA-approved therapies for which the subject is eligible have been exhausted (with the exception of PRRT), unless available therapies are refused by the subject (with the exception of somatostatin analogue, octreotide, and somatuline).

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lu177 DOTATOC treatment
4 doses of 200mCi 177Lu- DOTATOC PRRT
Drug: 177Lu-DOTATOC
177Lu labeled somatostatin receptors targeting ligand

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the overall response rate
Time Frame: 12 monts
determined using standard of care scans NETSPOT PET/CT, Octreoscan SPECT/CT, MRI
12 monts

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 12 months
determined using standard of care scans NETSPOT PET/CT, Octreoscan SPECT/CT, MRI
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Excel Diagnostics and Nuclear Oncology Center

Investigators

  • Principal Investigator: Ebrahim Delpassand, MD, Excel Diagnostics and Nuclear Oncology Center
  • Study Director: Rodolfo Nunez, MD, Excel Diagnostics and Nuclear Oncology Center
  • Study Director: Afshin Shafie, MD, Excel Diagnostics and Nuclear Oncology Center
  • Study Director: Ayman Gaber, MD, Excel Diagnostics and Nuclear Oncology Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2020

Primary Completion (Actual)

July 15, 2021

Study Completion (Actual)

July 15, 2021

Study Registration Dates

First Submitted

February 14, 2020

First Submitted That Met QC Criteria

February 17, 2020

First Posted (Actual)

February 19, 2020

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 9, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 143631

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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