Table of Contents
- Trial overview
- Children with recurrent or refractory neuroblastoma
- Adults with gastroenteropancreatic neuroendocrine tumors
- Extensive stage small cell lung cancer study
- Key endpoints and what they mean
- Who may join these studies
Trial overview
The trial data provided here describe studies of Arginine Hydrochloride in cancer research settings, mostly as part of larger treatment plans.[1][2][3][4]
Across the listed studies, researchers are testing safety, finding the right dose, and measuring how well treatment may work in different patient groups.[1][2][3][4]
The studies include a Phase 1 trial, a Phase 2 trial, and a Phase 3 trial, showing that the research ranges from early dose-finding work to larger comparisons of treatment benefit.[1][2][3][4]
Children with recurrent or refractory neuroblastoma
One completed Phase 1 study enrolled children with recurrent or refractory neuroblastoma, which means the cancer came back or did not respond well to prior treatment.[1]
The main goal was to define the Maximum Tolerated Dose (MTD) of 177Lu-DOTATATE, which is the highest dose that can be given without too many serious side effects.[1]
The study also tracked the dose limiting toxicity period from the first injection until 6 weeks after the first injection, so researchers could see if early side effects limited treatment.[1]
This study enrolled 18 participants and was completed, so it gives early safety information for this child cancer group.[1]
Adults with gastroenteropancreatic neuroendocrine tumors
One authorised Phase 2 study is looking at adults with gastroenteropancreatic neuroendocrine tumours and dominant liver metastases, meaning the cancer has spread mainly to the liver.[2]
The study compares uptake of 68Ga-DOTA-peptides on PET scans after intra-hepatic injection and after intravenous treatment, so researchers can see how much of the tracer reaches the liver tumors.[2]
The primary endpoint is the Maximum Standardized Uptake Value (SUVmax) in up to 5 liver metastases, which is a scan measure of how strongly the tumor takes up the tracer.[2]
This study has an enrollment of 23 participants and focuses on imaging results rather than survival outcomes.[2]
Extensive stage small cell lung cancer study
Another authorised study is a Phase 1 and Phase 2 trial in newly diagnosed patients with extensive stage small cell lung cancer.[4]
The Phase Ib part is designed to find the recommended dose of [177Lu]Lu-DOTA-TATE when it is used with carboplatin, etoposide, and atezolizumab in induction treatment, and with atezolizumab in maintenance treatment.[4]
The Phase II part compares the experimental treatment with standard care and measures overall survival (OS), which is the time from randomization until death from any cause.[4]
This study also tracks adverse events, serious adverse events, and treatment stopping because of side effects, which helps researchers understand safety in a larger group of 138 participants.[4]
Key endpoints and what they mean
The listed trials use different endpoints because each study has a different purpose.[1][2][3][4]
- Maximum Tolerated Dose: this helps find the highest dose that can be used safely in the study population.[1]
- Dose limiting toxicities: these are side effects that are severe enough to stop dose increases or limit treatment.[1][4]
- PET-scan uptake: this shows how much of the study tracer collects in the tumor, which may help judge targeting of liver metastases.[2]
- Progression-Free Survival: this measures how long the cancer stays controlled before it gets worse or the patient dies.[3]
- Overall Survival: this measures time until death from any cause and is one of the most important outcomes in cancer trials.[4]
Who may join these studies
The studies involve different age groups and cancer types, so eligibility depends on the specific trial.[1][2][3][4]
Children were included in the neuroblastoma study, while adults were included in the gastroenteropancreatic neuroendocrine tumor study and the small cell lung cancer study.[1][2][4]
Some studies focus on newly diagnosed patients, while others focus on cancer that has returned, not responded to treatment, or spread to other organs.[1][2][4]
Because each trial has its own goals, the best fit depends on the cancer type, stage of disease, and the treatment plan being tested.[1][2][3][4]
