Changing Clinical Trials

August 2, 2013

Clinical drug trials are by nature a bit of a gamble. The drug itself is experimental. It’s either a brand new drug or a brand new application for an existing drug. In any case, neither the drug’s effectiveness nor a positive result for the patient are guaranteed.

As the patient, you’re well aware of this; especially if you’re participating in the trial because you have cancer. In my case, choosing to participate in a clinical trial was made simple because it was the only choice I had left. Surgery was no longer an option for me. My type of bone cancer, a rare type called Chondrosarcoma, had progressed to the point where it was inoperable. Given the circumstances, a clinical trial made sense for me.

It’s obvious why clinical trials start, but you should know they can stop for a number of reasons. Sometime the drug simply isn’t working against your cancer. Other times the side effects become too much to handle. Or the drug company isn’t seeing enough in the way of positive results for the patients enrolled in the study. My first clinical trial ended for that exact reason. The drug company cancelled the trial because the result from the actual drug were no better than the placebo.

Truth be told, I was actually relieved. I’d been considering withdrawing from the trial because the side effects had gotten brutal and the drug wasn’t helping my tumors. There was another clinical trial waiting in the wings, so after a month-long withdrawal from the first drug to ensure my system was back to normal, I switched to the new drug trial.

The initial results had been hopeful. The cancer tumors in my leg and arm were stable and did not move. There was no more evidence of metastasizing from the tumors in my lungs. The lung tumors themselves become so transparent they were frequently hard for the radiologist to spot on the chest x-rays. The exception in an otherwise flawless series of scans was the group of tumors in my left leg, near the site of a cancer-related amputation. Slight tumor growth continued there, but it was not occurring at a rate that could be called progressive…until now.

The measurements from the last set of scans in early July showed my leg tumors growing at a rate beyond what the trial protocol permitted. At this point, I am staying on the clinical trial through a waiver, pending the results of my next set of scans at the end of August. If the growth has stopped, I’ll be allowed to stay on the trial. If not, I’ll be taken off of the trial and we’ll have to look at what other options exist.

Right now, the choice of options is loaded with qualifiers. There is a chance I could continue with the current drug off-study, since it is already FDA approved for some types of cancers. The question is whether I would be approved under those guidelines, and whether or not my insurance would cover the cost of the drug and being treated at MD Anderson. Or maybe I will have to try a new clinical trial.

Finding the answer to these and other questions about switching trials is a lot like trying to find the right way to treat cancer. There are plenty of choices, you just need to find the one that will do the most good with the least damage. As with everything else related to your cancer treatment, talk to your healthcare team first about changing clinical trials.

Your doctor and your clinical nurse will have a good idea about what other trials are available and what ones will be starting soon; even if the trial isn’t recruiting patients yet. Based on your medical history, they can tell you what trials you can consider.

Before you can start a new clinical trial, you have to stop the old one. This will involve meeting with your doctor and clinical nurse, filling out paperwork officially withdrawing you from the study, the usual check of your vital signs and other items that are part of your baseline, followed by a thirty day washout period to allow your system time to purge all of the trial drug from your body.

Starting the new trial will involve the now-familiar process of paperwork, exams and scans to establish a new baseline for the clinical study. Sometimes the results from previous exams can be used as your new baseline. Sometimes you have to get new exams. Your doctor and clinical nurse will be able to verify which approach you can take.

As before, it will take a bit of time for your application to get processed so you can be enrolled in the clinical trial. Once you’re approved for enrollment, you’ll come back in for the required exams and tests, and to get your initial prescription of the new drug.

I need to mention that the actual time needed to get your prescription from MD Anderson’s pharmacy can vary for a couple of reasons. If your trial drug is completely experimental, the dispensing of it is rigidly controlled to ensure that only patients on the clinical trial are given the drug.

This can make the wait time longer because the drug has to be brought to the pharmacy where you’re waiting. It isn’t stocked on the shelf. If you are on a trial for a drug that is approved for other cancers, but is experimental for your type of cancer, the wait time is often shorter because the drug is usually stocked on pharmacy shelves.

And like any clinical trial, you need to stay in close touch with your doctor and clinical nurse regarding how the drug is affecting you. Any change in sleep patterns, energy level, appetite, or overall feeling of health, good or bad, is something your healthcare team needs to know about. All of those points can indicate how well the drug is working for you, and can help your doctor make adjustments to your dosage to help the drug work better.

Like I said in the beginning, clinical drug trials can feel like a bit of a gamble. And you need to thoroughly research the process before deciding if it’s the right path for you to take. Like so many other choices we must make as cancer patients, MD Anderson has the resources to help you make an informed decision. Starting or re-enrolling in a clinical trial might be the right choice for you or it might not be. But you’ll never know unless you ask.

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