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

  • STATUS
    Recruiting
  • End date
    Jul 30, 2024
  • participants needed
    50
  • sponsor
    Excel Diagnostics and Nuclear Oncology Center
Updated on 18 July 2021
octreotide
absolute neutrophil count
measurable disease
somatostatin
MRI
blood test
MRI Scan
bone scan
18f-fdg
paraganglioma
pheochromocytoma
positron emission tomography/computed tomography
neuroendocrine tumor
dotatoc
fdg pet/ct
prrt
adrenal pheochromocytoma

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.

Details
Condition Thymus Carcinoid, Merkel cell carcinoma, paragangliomas, neuroendocrine tumour, Neurectoderma, Malignant Pheochromocytoma/Paraganglioma, tumor, unknown primary, Metastasis, Bone Metastases, Neuroendocrine Neoplasm of Ovary, Paraganglioma, phaeochromocytoma, Pheochromocytoma, Neuroendocrine Breast Tumor, Neuroendocrine Tumor, adrenal pheochromocytoma, Liver Metastases, Neuroendocrine Carcinoma Metastatic, Neoplasms, Unknown Primary, Neuroectodermal Tumor, Metastatic Cancer, Brain Metastases, Neoplasm Metastasis, neuroendocrine tumors, Pulmonary Neuroendocrine Neoplasm
Treatment 177Lu-DOTATOC
Clinical Study IdentifierNCT04276597
SponsorExcel Diagnostics and Nuclear Oncology Center
Last Modified on18 July 2021

Eligibility

Yes No Not Sure

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/l and WBC2,000/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 mol/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)
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