Clinical Trials /

Phase-II Study of Lu177DOTATOC in Adults With STTR(+)Pulmonary, Pheochromocytoma, Paraganglioma, Unknown Primary, Thymus NETs (PUTNET)

NCT04276597

Description:

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

Related Conditions:
  • Adrenal Gland Pheochromocytoma
  • Lung Neuroendocrine Neoplasm
  • Neuroendocrine Carcinoma of Unknown Primary
  • Paraganglioma
  • Thymic Neuroendocrine Neoplasm
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase-II Study of Lu177DOTATOC in Adults With STTR(+)Pulmonary, Pheochromocytoma, Paraganglioma, Unknown Primary, Thymus NETs (PUTNET)
  • Official Title: A Phase II, Non-Randomized, Open-Label, Single-center, Physician Sponsored, Study to Determine the Safety and Effectiveness of 177LuDOTATOC in Adult Subjects With STTR(+) Pulmonary, Pheochromocytoma, Paraganglioma, Unknown Primary, Thymus Neuroendocrine Tumors (PUTNET)

Clinical Trial IDs

  • ORG STUDY ID: 143631
  • NCT ID: NCT04276597

Conditions

  • Pulmonary Neuroendocrine Neoplasm
  • Pheochromocytoma
  • Paraganglioma
  • Thymus Carcinoid

Interventions

DrugSynonymsArms
177Lu-DOTATOCLu177 DOTATOC treatment

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Lu177 DOTATOC treatmentExperimental4 doses of 200mCi 177Lu- DOTATOC PRRT
  • 177Lu-DOTATOC

Eligibility Criteria

        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).
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:determined using standard of care scans NETSPOT PET/CT, Octreoscan SPECT/CT, MRI

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Excel Diagnostics and Nuclear Oncology Center

Last Updated

February 17, 2020