Thank you for your support of Believe Big that has allowed me to investigate mistletoe in the first intravenous clinical trial in the united states.
We designed a trial that would measure patient safety, whether mistletoe kills tumor cells, and also whether mistletoe would also improve our patients’ quality of life.
The primary goal of the trial is to test drug safety and to identify the recommended Phase 2 dosing.
The secondary goals are to test tumor marker growth as measured with cat scan imaging and in the blood for specific cancers such as PSA for prostate cancer, CA19-9 for pancreas cancer, as well as others.
We also wanted to explore potential biomarkers to evaluate germline genetic mutations in circulating DNA and immunological markers.
Patient eligibility criteria requires that a patient have stage 4 cancer, have received at least one line of prior therapy, and have a life expectancy of greater than three months.
A standard phase 1 design was used where three patients in the trial are assigned to a dose level in order of the study entry until a patient experiences a drug-related toxicity of a grade three or higher, where upon an additional three patients will be enrolled at that dose level.
To date I have consented 18 patients into the trial and am expecting a handful more to complete the trial. Before the global covid 19 pandemic, we were on target to finish as planned in the next year. The trial may take up to another 2 years to complete because right now all non covid 19 related phase 1 trials are on hold in the setting of the outbreak. My hope is that once this is all behind us, we can safely resume and complete the trial within months.
What I am most excited about in this trial is to see not only whether we controlled cancer in our patients but also whether we improved their quality of life. Many patients feel they want to focus more on quality of life than on the toxic side effects of chemotherapy. I had one couple tell me the other day that quality was more important to them than quantity. I hope one day we will be able to say that this drug called mistletoe is safe and may even improve quality of life for our patients.
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