An Italian multicenter trial with Temozolomide taken daily at low doses continuously in patients with well differentiated neuroendocrine neoplasia (NENs) and in a clinical frailty status
- Conditions
- Patients with well differentiated neuroendocrine neoplasia (NENs) not eligible for active antitumoral treatments due to their clinical conditions.MedDRA version: 20.0Level: PTClassification code: 10057270Term: Neuroendocrine carcinoma Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2024-510898-24-00
- Lead Sponsor
- European Institute Of Oncology S.r.l.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 46
Age > 18 years, Histologically proven diagnosis of low grade GEP-NENs (in accordance with WHO 2019 classification), bronchial carcinoids (in accordance with the Travis classification), low grade of unknown primary sites NENs, Advanced disease (unresectable locally advanced or metastatic);, ECOG performance status 2 and/or moderate medullary impairment (at least one of the following criteria: Hb concentration <10-8 gr/dl; WBC <3000-2000/mm3; platelets <75000-50000/mm3; neutrophil count <1500-1000/mm3); renal failure (eGFR o CrCl 30-59 ml/min – G2) and/or moderate liver failure (Child B 7-9) and/or severe comorbidities and/or > 3 prior systemic antitumor therapies (apart from SSA), Functioning/non functioning, Clinical and/or radiological progressive disease (CT scan or MRI);, Recovery from toxicities related to any prior treatments, adequate wash-out period from previous treatments, Ability to swallow pills, Fertile men should agree to use effective contraceptive methods up to 6 months after the last temozolomide intake and should be informed about the possible irreversible infertility related to temozolomide intake.
Women of Child-Bearing Potential (WOCBP) and men who are able to father a child, unwilling to use adequate contraception prior to trial entry, for the duration of trial participation and for at least 28 days 2 weeks after treatment has ended. Adequate methods of contraception and Women of Child-Bearing Potential; WOCBP childbearing potential who are nursing or are pregnant or do not agree to submit to pregnancy testing required by this protocol;, Patients that did not sign written informed consent prior to admission into the trial that is consistent with International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP) guidelines and local law, Known active hepatitis B infection (defined as presence of Hepatitis B (HepB) sAg and/or HepB DNA), active Hepatitis C (HEP C) infection (defined as presence of Hep C RNA) and/or known Human Immunodeficiency Virus (HIV) carrier, Patients treated with systemic therapies (chemotherapy, interferon-alpha, somatostatin analogues, molecular target therapies) within 1 month prior to screening visit, Hypersensitivity to the active substance or to any of the excipients, hypersensitivity to dacarbazine (DTIC), known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before study entry, pregnant or lactating females, patients on chronic treatment with valproic acid.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Progression free survival (PFS).;Secondary Objective: Objective response rate (ORR) that means complete response (CR) + partial response (PR) in progressive, metastatic, low grade NENs., Duration of response., Overall survival (OS)., Safety., Quality of life (QoL), Centralized evaluation of O6-methylguanine-DNA-methyltransferase (MGMT) status in tumor tissue to correlate clinical outcomes and MGMT status and validate the method of MGMT determination.;Primary end point(s): Progression free survival (PFS)
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Objective response rate (ORR) that means complete response (CR) + partial response (PR) in progressive, metastatic, low grade NENs;Secondary end point(s):Duration of response;Secondary end point(s):Overall survival (OS).;Secondary end point(s):Safety;Secondary end point(s):Quality of life (QoL);Secondary end point(s):Centralized evaluation of O6-methylguanine-DNA-methyltransferase (MGMT) status in tumor tissue to correlate clinical outcomes and MGMT status and validate the method of MGMT determination