This trial has completed recruitment on this platform, and is no longer accepting new referrals.
This is a phase I/II, open-label study to investigate the safety and preliminary anti-tumor efficacy of orellanine in patients with metastatic clear-cell or papillary renal cell carcinoma. The study will include an intra-patient dose escalation phase, followed by a dose expansion phase.
This study will enroll patients with metastatic renal cell carcinoma who are in end-stage disease, dependent on hemodialysis, and for whom no conventional therapy is available or considered appropriate by the treating physician. The compound to be investigated is orellanine, a highly kidney-specific agent with promising preclinical results of tumor-eradication.
The study is divided into an accelerated dose escalation phase and a dose expansion phase. In the dose escalation phase, 6-20 patients will be enrolled, and it will consist of intra-patient dose escalation up to maximum planned dose. Orellanine is administered as an intravenous infusion (over half an hour) on the day after haemodialysis. Patients will receive orellanine on Day 2 of each four-week cycle. Patients will undergo haemodialysis on Days 1 and 3; the Day 3 haemodialysis will begin 24 ±1 hours after dosing. Patients will be scanned between Days 22 and 24, allowing alignment with a weekday schedule and providing time for analysis of response prior to the next dose.
In the dose expansion phase, additional patients will be recruited (up to a total of 20 treated at the recommended Phase 2 dose [RP2D]) to better characterize drug safety, tolerability, and preliminary efficacy.
Who is eligible for the study? Only patients who have certain kinds of kidney cancer (clear or papillary cell renal carcinoma). These patients must already be on dialysis and have very little ability to make urine. Orellanine will kill both normal kidney cells and cancerous kidney cells, so the treatment cannot be offered to patients with normal kidney function.
What is involved? Orellanine is given once a month into a vein over a half hour. The patient will have dialysis the day before and after this. Blood samples will be taken for lab tests before the drug is administered as a safety check and afterwards both for safety and to see how the drug is working. A CT scan will be performed once a month to see if tumors are changing size.
Where will this take place? The treatment will take place at Karolinska University Hospital in Stockholm. Since most patients do not live near this hospital, the company supporting the trial will cover all travel and lodging costs related to getting to and from the hospital. A dedicated travel agent will help to plan the visit and take care of paperwork. If the patient wants a friend or a nurse as a travel companion, that cost will also be covered.
Some questions that patients may have:
Your patient will need to travel to the site below to participate.
Sites are located in the cities/states identified with the red pin: