Todd Mercer, a fifty-two year old Michigan resident and father of two, recently called into STAT’S Podcast The Readout LOUD to discuss the difficulty he has had getting enrolled in a clinical trial. Todd explained that his appendix cancer was discovered two years ago during an operation for a burst appendix.
Only six weeks earlier, Todd had a routine colonoscopy and was told that he was in fine condition. Apparently the tumor that ruptured the appendix was not in the vicinity of the endoscopic exam. The diagnosis was stage 4 appendix cancer and it had spread to his liver and lungs.
For a time after the operations, Todd’s cancer was in remission. However, it returned in November 2018. It was then that he started his search for a clinical trial.
At first Todd was looking for what he termed to be ‘new and exciting’ scientific trials. Then after he had several genetic tests he was drawn to trials designed to evaluate very specific characteristics that the tests identified. Todd recommends genetic testing for every cancer patient.
Todd’s Three Obstacles
Although there are thousands of clinical trials, there are also very specific requirements for enrollment. Todd explained some of the reasons he had been turned down for enrollment.
Todd said that his biggest obstacle is because the tumor originated in his appendix. Most trials are testing therapies to treat cancer at a specific site of origin. Therefore, only people with cancer that originated at that site are eligible to enroll.
He explained that someone with an ‘orphan’ disease that would not fit the trial design would be of no benefit to the study. Todd said that there are only a few trials that are designed to test his appendix cancer and timing the open enrollment is not easy.
Todd gave a thorough explanation of his second obstacle: measurable disease. That means that the cancer has begun to form so that physicians can take a measurement. He gives the example of a radiologist who can measure the size of the cancer and estimate how treatment would affect it. Todd said that most trials will not accept patients whose disease is not considered measurable.
Then there is another issue called ‘evaluable disease’ which means that although the cancer may not be measured in a technical sense, it can be evaluated. Todd accepts the fact that he must locate an evaluable trial because his cancer is not measurable.
The third obstacle is exposure to other drugs. The studies have an obligation to enroll people who have not been given other drugs. This ensures that results will be from the study therapy and not residual from previous therapies.
About Todd’s Previous Medications
Todd was aware that immunotherapies have not only put many patients in remission but have been responsible for cures. Unfortunately after being treated he did not show positive results, but now he can no longer participate in any studies involving immunotherapy.
Taking into consideration the fact that Todd’s cancer is rare, he agreed to try medications that were not yet fully approved by the FDA (off-label). His oncologist tried several drugs using the same methods used in the clinical trial for that particular drug.
This would ensure that the drug is safe and that it will not have any unforeseen consequences.
Other Patients Have Been Rejected
During the podcast, Todd was asked what he has learned from other patients who have been rejected when trying to enroll in clinical trials.
He answered that he does not have too much knowledge on the subject. He does know, however, that some patients are turned away if their disease has progressed substantially and they have a lower tolerance level.
Todd says that he advises patients not to wait until there are no other options but to enter a trial while the patient is still reasonably healthy.
Cost is another factor. Although the trial generally pays for drugs, many times it will not pay for travel or doctor and radiology exams. Therefore, without adequate insurance, the costs can become prohibitive.
About Todd’s Sixth Enrollment Attempt
Todd had attended a business conference in San Francisco a month ago and sat next to a clinical trial director on the trip back home. As it turned out the director was in charge of the trial that Todd was hoping to enter.
There are no openings in the trial at this time because it is in the dose escalation phase. The early stages of the trials involve testing for safety and maximum tolerability, so Todd must wait.
Todd’s cancer is progressing. While he is waiting for an opening in the new trial he has no other option but to revert to a treatment that he was on last year. He is hoping that it has some effectiveness even though it failed him previously.
If a slot opens up for him, he will have to go through a twenty-eight day ‘detox’ period without any medication or chemotherapy. According to his genetic mapping, this trial involves the two drugs that his genetic tests show have the highest potential to block his cancer.Todd is pleased that the trial is being conducted only a short distance from his home.
Clinical Trials Bring Hope
Todd believes that he only has between five to ten years with the current standard of care. He said that along with understanding his disease and becoming his own counsel, the trials are one of his very few options. They bring hope of new drugs and therapies. That is why his sixth possible enrollment brings new urgency.
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