Patients must have histologically or cytologically confirmation of neuroendocrine tumors or any other tumor histotype documented as sst-positive MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: 177Lu-edotreotide or 177Lu-octreotide
Product Code: [177Lu-DOTATOC_IRSTIRCCS]
Pharmaceutical Form: Solution for infusion
Current Sponsor code: 177Lu-DOTATOC_IRSTIRCCS
Other descriptive n
Sponsors
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age =18 years. 2) Patients must have histologically or cytologically confirmation of neuroendocrine tumors or any other tumor histology type documented as sst2-positive, that may benefit from receptor radionuclide therapy and for which there aren’t any other effective treatments. For cerebral and PPGLs sst2-positive tumors, if biopsy is no feasible for technical reason or risk benefit balance, patients may be enrolled if CT or MRI strongly suggest oncological lesion confirming the 68Ga PET-CT dota-peptide SSTr2 positivity. 3) Measurable disease according to RECIST 1.1 criteria also patients without measurable but with evaluable disease can be enrolled. 4) Any disease stage is allowed. Patients with documented disease will be admitted to the therapeutic phase only if the diagnostic PET/CT 68Ga-peptide images demonstrate a significant uptake in the tumour. 5) Patients with progressive disease in pre-study period (PD within the last 12 months), refractory to conventional standard treatments; clinical progression is allowed. 6) Patients with or without concurrent therapy with somatostatin analogs. 7) Life expectancy of greater than 6 months. 8) ECOG performance status =2. 9) Adequate haematological, liver and renal function: haemoglobin >= 9 g/dL, absolute neutrophil count (ANC) >= 1.5 x 109 /L, platelets >= 100 x 109 /L, bilirubin =1.5 X UNL (upper normal limit), ALT and AST =65 years) yes F.1.3.1 Number of subjects for this age range 134
Exclusion criteria
Exclusion criteria: 1) Patients treated with chemotherapy and therapeutic radiotherapy within 4 weeks and treated within 2 weeks with palliative radiotherapy, hormonal or biological therapy. 2) Patients treated with previous PRRT with an absorbed dose to the kidney more than 23 Gy and more than 1.8 Gy for the bone marrow or as surrogate of dosimetry. 3) Patients which are included in the indication of LUTATHERA® 4) All acute toxic effects of any prior therapy (including surgery radiation therapy, chemotherapy) must have resolved to a grade = 1 according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE). 5) ECOG performance status >2. 6) Participation in another clinical trial with any investigational agents within 30 days prior to study screening. 7) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 8) Assessed bone marrow invasion > 50% (with Bone Marrow biopsy or instrumental exams i.e bone scan or CT or MRI). 9) Pregnant or breastfeeding women are excluded from the present study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this phase II basket study is to evaluate the efficacy of 177Lu-DOTATOC in five different cohorts of SSTR-positive tumors (Ga-dotatoc positive PET/TC) defined as follow: 1) NETs retreated with PRRT 2) Bronchopulmonary NETs 3) Meningiomas 4) Pheochromocytomas and paragangliomas 5) Other SSTR-positive tumors.;Secondary Objective: The secondary objectives are the assessment of safety, efficacy in terms of PFS (for cohorts 2,3,4,5) or DCR (for cohort 1) and OS, and evaluation of quality of life (QoL);Primary end point(s): For the cohorts 2,3,4 and 5 the primary endpoint is DCR, defined as the percentage of patients who have achieved complete response, partial response, stable disease (according to RECIST 1.1) at the 1st planned evaluation. For the first cohort a time to event outcome was chosen (PFS), according to a higher level of evidence from literature data.;Timepoint(s) of evaluation of this end point: 2 years since last therapy cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Quality of life evaluated through validated standardized data collection forms from the EORTC QLQ-C30 questionnaire.; Safety, evaluated according to version 5.0 CTC-AE, defined as the percentage of patients who experience acute toxicity from the 1st treatment until 30 days after the last treatment cycle or late toxicity that occurred after 30 days from the last treatment administration up to 6 months.; PFS (progression free survival) for cohorts 2, 3, 4 and 5 defined as the time from the start treatment date to the date of first observation of documented disease progression or death due to any cause. Patients without tumor progression at the time of analysis will be censored at their last date of tumor evaluation.; Overall survival defined as the time from the therapy start to the date of death due to any cause or the date of last contact (censored observation) at the date of data cut-off.; DCR (disease control rate) for cohort 1 defined as the percentage of patients who have achieved complete response, partial response, stable disease (according to RECIST 1.1);Timepoint(s) of evaluation of this end point: 5 years and 6 months; Acute toxicity from the 1st treatment until 30 days after the last treatment cycle or late toxicity that occurred after 30 days from the last treatment administration up to 6 months.; 2 years since last therapy cycle; 2 years; 2 years | — |
Countries
Italy
Contacts
Public ContactCentro di Coordinamento
IRCCS IRST
Outcome results
None listed