How do I volunteer for the trial?
First REGISTER on this website. You will then be guided through a process for pre-screening. If you are found to qualify, arrangements will be made for you to visit the principal investigator (PI). If you sign the informed consent and the PI and the Sponsor agree you are eligible to participate in the clinical trial, you will undergo a series of screening tests. If you pass all the screening tests, you will accrue into the clinical trial.
Can I Register and Later Change My Mind?
Participation in the clinical trial is entirely voluntary. You can enroll in the trial and withdraw at any time without having to provide a reason.
Will I be Charged to Participate in the Clinical Trial?
The Sponsor provides the study drug at no cost and will cover all expenses of the clinical trial that are considered “experimental” or treatment of side-effects caused by the experimental drug. You or your insurance company will be responsible for any prescription medications and standard care provided related to your disease. You will also be responsible for your own travel, room and board expenses.
What are the chances that the experimental drug will work?
The experimental drug is still in clinical testing and has not been approved by the FDA. No studies have yet been performed that can predict the chances of the experimental drug to provide benefit to any patient. It is possible that the experimental drug could provide you benefit, but also possible that the drug could not work at all or could even make your condition worse.
Can the experimental drug be administered in my home town?
No. The experimental drug can only be administered at Banner MD-Anderson in Phoenix, Arizona.
Has the experimental drug been approved in any location in the world?
No. The experimental drug is currently under investigation in the USA and Thailand, but has not been approved by regulatory agencies for general use in any jurisdiction.
Can my current doctor participate in the clinical trial?
Yes. We are happy to collaborate with your oncologist and provide information so that your doctor can provide you with follow-up care.
How long do I need to stay in Phoenix?
The entire experimental treatment protocol takes between 112-119 days. You should plan to stay in the Phoenix area for at least 35 days. After the first 35 days, you can return home, but you must return for additional experimental treatments every 28 days thereafter until the end of the protocol.
Can I continue to receive the experimental drug after the completion of the protocol?
Yes. If the principal investigator believes you are benefiting from the drug, it is possible to continue to receive booster infusions after the completion of the protocol, but again these can only be provided at Banner-MD Anderson in Phoenix.
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