cancer patients MedDRA version: 9.1 Level: LLT Classification code 10028980 Term: Neoplasm
Conditions
Interventions
Product Name: 177lu DOTATATE
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Octreotide
Concentration unit: mCi millicurie(s)
Concentration type: equal
Concentration number: 100-
Sponsors
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients, male and female, with the following: - Histologic diagnosis of neuroendocrine tumors or any other tumor histotype, documented as sst2-positive (breast, small cell lung cancer, Hodgkin and Non-Hodgkin lymphoma, high-grade glioma), that may benefit from receptor radionuclide therapy and for which there aren?t any other effective treatments. - Conserved hematological, liver and renal parameters, and in particular: - WBC >2500/μl (ANC>1500/μl); Hb>10g/dl; PTL >100.000/μl; Bilirubin 18 years; - Patients with documented disease will be admitted to therapeutic phase only if the diagnostic OctreoScan images demonstrate a significant uptake in the tumour. The tumour uptake will be evaluated with a 3-grade scale, where 1 is the liver uptake and 3 the kidney one: only tumour uptakes grade 2 and 3 will be considered for therapy. - Both local relapses and metastases will be treated. - Disease must be measurable by means of conventional imaging (US, CT, RM). - Before treatment anamnestic data will be collected, physical examination will be performed and diagnostic and laboratory data will be examined. - Patients must not receive other treatments (e.g. chemo- or radiotherapy) from one month before to two months after the completion of 177Lu-DOTATATE cycles. - Before the radiopharmaceutical administration, each patient will be informed about the nature, aim and potential risks of the study, and will sign an informed consent (see attached document n.1) before the beginning of therapy. Principal investigator must guarantee that the research will be conducted according to the ?Declaration of Helsinki?, in 1964, revised during the 41st World Medical Assembly, in 1989 in Hong Kong, the 48th (Somerset West, 1996) and the 52nd (Edinburgh, 2000) World Medical Assemblies. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patients not corresponding to the above criteria. - Pregnancy/breastfeeding (a pregnancy test not older than 7 days is mandatory). - Assessed bone marrow invasion. - Other concomitant neoplasm (excluding in situ basaliomas and radically treated cervical cancers). - ECOG score higher than 2. - Expectancy of life shorter than 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this disease-oriented phase II, open-label, non-controlled study is to evaluate the objective response of 177Lu-DOTATATE treatment in patients affected by sst2 positive tumours.;Secondary Objective: The second objective is to evaluate the acute toxicity to and the time to progression in the single tumour histotypes.;Primary end point(s): ORR | — |
Countries
Italy
Outcome results
None listed