In order to volunteer for the clinical trial, you will first need to undergo a pre-screening procedure. There is no cost to participate in the clinical trial. However, you will be responsible for your travel costs. In addition, some medical procedures that are considered to be standard of care or treatments for complications of your disease unrelated to the study drug you may be responsible for or they may be billed to your insurance.
You will need to agree to reside in the Phoenix area for approximately 38 days to complete the initial course of experimental therapy and return to Phoenix monthly thereafter for at least two months for booster infusions of the experimental drug. We understand that patients with this difficult diagnosis have a sense of urgency and we wish to provide you with the assistance you need in order to determine if you qualify for this trial quickly and assist you to determine if this is a clinical trial in which you wish to volunteer to participate.
The pre-screening procedure involves:
- Register on this site
- Review the informed consent form;
- Forward Medical Record Summary
- Meet with the Investigator
- Sign the Informed Consent Form
- Undergo screening procedures
If all above are successfully completed, you will be able to accrue into the clinical trial and will begin to receive your experimental therapy. You will receive a schedule of your experimental treatment days. Experimental treatment days are scheduled for Tuesdays and Fridays of every week.
If you or your loved one are interested in being pre-screened for eligibility for this Phase IIb therapeutic vaccine immunotherapy clinical trial, please click the REGISTER button and fill the form. This is a no obligation and no cost to register. We only ask for your contact information in the registration form.
Once you register, you will be sent a copy of the Informed Consent form for the clinical trial by email or regular mail. Please read this form carefully. This form will describe the protocol and disclose the potential risks. You will have an opportunity to discuss the details of the study and the risks identified in the form with a study doctor prior to being asked to sign the document. You are also encouraged to consult with your doctor, family and friends regarding the clinical trial.
Details about the clinical trial can also be found at the National Institutes of Health Website:
Details about the technology can be found at the Sponsor’s website:
After you register, you will be sent an email requesting your medical summary information. The following information will be requested:
- HPI (history of present illness) summary from your current medical provider
- Your latest laboratory blood test results
- Your latest radiological imaging report
If you have any questions or difficulties obtaining this information, you will be provided contact information of someone associated with the study to assist you. Once we receive your medical information, our medical monitor will review the information.
If the information is not complete, the medical monitor may need to contact your oncologist. You will be provided a form to provide permission for your oncologist to speak with the Medical Monitor regarding your medical condition and candidacy for the clinical trial.
Our medical monitor will quickly screen your medical information. If it is complete, you will be notified within a few days of the eligibility decision.
Meet with the Investigator
Once you are found to be potentially eligible by the Medical Monitor, we will assist you to obtain a screening appointment with Dr Madappa Kundranda, MD, Ph.D. at Banner-MD Anderson Medical Center in Phoenix, AZ.
We can also assist to recommend local hotel and ground transportation.
Sign Informed Consent
At the office visit, Dr. Kundranda, or his authorized associate, will discuss with you the protocol and the informed consent form. You will have an opportunity to have all your questions about the study answered at this meeting. If you agree and decide to participate by signing the informed consent form, arrangements will be made for your screening tests.
Once you have signed the Informed Consent, you will undergo screening procedures to determine if you meet all the criteria for the clinical trial. These procedures can be scheduled the same day as your visit with Dr. Kundranda.
Screening tests include checking your vital signs, physical exam, detailed history of your disease, laboratory blood tests and may also include a CT scan and biopsy procedure. If you require CT scan and biopsy, the procedures may require several days to complete. Once the screening procedures are completed, you will be notified if you qualify for accrual into the clinical trial. If you qualify, you will be assigned to one of the six dose frequency arms of the protocol. You will be provided with a schedule of the planned experimental treatments.
There is no placebo or control arm. All enrolled participants will be scheduled to receive the experimental drug. In addition, while the clinical trial is evaluating several different dosing frequencies, all the cohorts deliver what is believed to be a potentially effective dose.