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Mistletoe Clinical Trial

At this time, per the study design, only one patient will be enrolled every 4-6 weeks.  Due to the high level of interest in the study, we are assessing eligibility for the study in advance of a visit to Johns Hopkins for patients that do not already have a Johns Hopkins' oncologist.  Please provide your name, date of birth, and the name and contact number for your medical oncologist to phase1trials@jhmi.edu or 410-502-5140.  The research team will follow up with you after we have received the information from your oncologist.  We will keep a limited waitlist for the study and patients will be informed promptly if they are on the waitlist or if it is full at the time that we receive all the information we need from your oncologist.

While mistletoe is utilized in Europe there remain many questions about whether it is beneficial.  This Phase I study is an important first step in helping us better understand the safety of mistletoe to patients with cancer.  The Phase I study provides information on side effects and how high a dose of mistletoe is well tolerated.

Mistletoe Clinical Trial Now Open

To be considered for the trial, each patient will need to:

  • Be evaluated in person by a Johns Hopkins Kimmel Cancer Center physician
  • Have advanced cancer (solid tumor)
  • Cancer must have progressed on at least one mode of conventional treatment
  • No prior use of mistletoe (injections or IV)
  • Be able to come to The Johns Hopkins Hospital in Baltimore to receive infusions 3 times a week (for 3-4 hours) for as long as you benefit or choose to be on the trial. Scans will be done every 8 weeks to monitor the size and sites of your disease.
  • This is a Phase 1 trial. This means Johns Hopkins researchers are testing the drug in a small group of participants to evaluate safety, determine a safe dose, and identify side effects. This is the first step of many research steps before mistletoe may be considered for commercial use.

To learn more about who is eligible to participate, please visit the clinicaltrials.gov or email: phase1trials@jhmi.edu.

Frequently Asked Questions About Mistletoe Therapy

Mistletoe is a plant that attaches itself to oak, pine, apple, and other types of trees. The liquid extract of the mistletoe plant has been used in Europe for close to a century to improve quality of life and improve survival in patients with cancer. Mistletoe injections are currently among the most widely used complementary cancer treatments in Europe. It is approved for palliative care use in several European countries but not yet in the United Kingdom or the United States.

How can mistletoe be used and will it be effective for my type of cancer?

Mistletoe (Helixor) can be used to treat many types of tumors and our trial is open to patients with any metastatic solid tumor.  Small clinical trials completed in Europe suggested that mistletoe may provide benefit to cancer patients and improve quality of life by reducing the side effects of chemotherapy/radiation such as nausea, vomiting, and lack of appetite, as well as diminishing tumor-related pain. Those trials were conducted using subcutaneous injections.  Only limited evaluation of mistletoe has been conducted in the United States. Johns Hopkins trial seeks to explore whether intravenous dosing of mistletoe is safe with the hopes of advancing to future trials that would test the effectiveness of the agent.

Why is mistletoe not available at cancer institutions in the United States?

Until further clinical testing is done here in the United States, oncologists cannot offer this treatment as standard of care for cancer patients. Mistletoe is being administered in the United States by complementary medicine practitioners.

How is mistletoe administered and how often?

Mistletoe can be administered subcutaneously (an injection) or intravenously (IV) at a frequency determined by the prescribing physician based upon patients’ individual needs. In our trial, it will be administered as a 3-4 hour infusion, 3 times per week.

More information about mistletoe.