Treatment and Clinical Trials
An interesting fact about cervical cancer treatment: Only 3 new cervical cancer treatments have been approved over the last 20 years. Surprising, isn’t it?
The treatments that we have happen to work well for many patients. But there are patients who have a high risk of recurrence, regardless of their stage. Recurrence depends more on lymph node involvement than stage of cancer. So women with stage 1 may be harder to treat than women in stage 4 because of their lymph nodes. And we don’t have medications that work well in women once they’ve had a recurrence. So there is work to do!
All this being said, in order to develop new treatments, we need to have clinical trials. The truth is, clinical research is the only way we ever can get any medications for any of our health conditions.
- We need clinical trials to drive progress.
- We need trials to determine the safety and effectiveness of every type of treatment.
- And in order to determine that safety and effectiveness, we need volunteers.
According to the American Cancer Society, “The biggest barrier to completing clinical trials is that not enough people take part in them. Fewer than 5% of adults (less than 1 in 20) with cancer will take part in a clinical trial.”
You may be asking, “doesn’t that just make me a guinea pig for some pharmaceutical company?” The answer is no! It makes you an important part of medical research, a person who is helping to further the science and develop new treatments.
“I decided that if this clinical trial was good enough for Jimmy Carter, it was good enough for me!” Teolita Rickenbacker
But what’s the benefit to the patient? There are a few:
- Access to innovative treatments: Clinical trials can give you access to innovative treatments that aren’t available to other patients. Only treatments that have been through clinical trials and are approved by the Food and Drug Administration (FDA) are available to patients.
- Dedicated care: When you are in a clinical trial, your clinicians are committed to providing high quality care and monitoring. They are also committed to finding new and advanced cancer treatments.
- Hope for success: Some patients run out of treatment options and clinical trials offer them hope. New and innovative therapies can be successful when other treatments stop working.
- Possible coverage of medical expenses: Some study sponsors may provide payment for your medical care and any expenses (such as travel or accommodations during your treatment).
“I think being on a trial saved my life. I wasn’t nervous about being on the trial. I was hopeful I would be accepted. At the time, the trial increased my odds by 16%. I had to travel from FL to Houston for treatment to participate but it was worth it to me. When I hear about trials and the research that is being done, I am grateful for the scientists committed to finding treatments that will save lives.”
Clinical Trials 101
There are four phases of clinical trials. These all occur after research has already been completed in the lab and the drug is ready to be given to a human being.
Phase I: Phase I trials find the highest dose of the treatment that can be used without causing serious side effects. Phase I studies often involve a small number of patients and are trying to determine the safety of the drug. Patients may have different kinds of cancer in Phase I.
Phase II: After a drug is shown to be safe in Phase I, it is tested in Phase II to figure out the optimal dose and provide data to show whether the drug works. Patients usually have the same type of cancer but it may be at different stages.
Phase III: After making it through Phases I and II, a drug can move onto Phase III if the earlier results are good. Phase III trials are large studies with hundreds or thousands of patients in multiple study centers around the U.S. and often around the world. Patients often have a specific type and stage of cancer. Phase III trials are used to produce evidence to support FDA approval of the drug. Note: Sometimes you hear about global randomized studies. This means that there are sites around the world and that patients are randomly assigned to either the treatment being studied or the standard of care treatment.
Phase IV: Phase IV trials are called post-marketing trials as they occur after a drug is approved. They follow patients for many years to determine long-term side effects.
How will I be protected in a clinical trial?
Anyone who enrolls in a clinical trial will have to provide informed consent. What this means is that the doctor explains the trial, the procedure, the costs (if any) and the potential benefits and risks. You will have to read through and complete a lot of paperwork and sign a lot of forms. During the informed consent process, you want to be prepared with any questions. This is the time to ask the doctor what the logistics of the trial are, what will happen during the trial, and what you need to be prepared for during the trial. This is the time where you decide whether the trial is right for you.
Should you participate in a clinical trial?
There are many factors you should discuss with your clinician, review with your family, and think through for yourself.
1 – Understand the risks.
2 – Know what the benefits are.
3 – Find out if there are costs involved or if everything will be covered.
4 – See if the logistics will work for you and your family (including appointment schedule, transportation and lodging requirements if necessary, etc.)
5 – Think about your goals and expectations for the trial. Are they realistic? What do you hope to get out of the trial?
“My next treatment will probably be through a clinical trial. Scientists know that with recurrent cervical cancer, traditional treatments stop working sooner or later. And doing too many chemotherapy treatments could diminish the chances of being accepted in some clinical trials, so I need to choose each treatment strategically.”
Important Facts About Clinical Trials:
- Participation in a clinical trial is voluntary.
- There are very specific eligibility criteria for each trial. You may or may not be able to participate depending on your circumstances.
- You must give your written, informed consent before you take part in a trial.
- You have the right to leave the study at any time for any reason.
Below are some current clinical trials in cervical cancer:
- AIM2CERV Study (Global, randomized Phase 3): The goal of the AIM2CERV (Advaxis IMmunotherapy 2prevent CERVical recurrence) study is to develop a treatment to prevent or reduce the risk of cervical cancer recurrence after primary, standard of care treatment in women who are at high risk of recurrence.
- ADVANCE Study: The goal of the ADVANCE (ADVAxis Immunotherapy with Nivolumab to Treat Recurrent or Metastatic CErvical Cancer) study is to develop a second line treatment for cervical cancer patients who failed first line treatment in women with recurrent or metastatic cervical cancer.
- MediCombo Study (Phase ½): The MediCombo clinical study is for patients with recurrent/persistent or metastatic carcinoma of the cervix or metastatic HPV+ squamous cell carcinoma of the head and neck (SCCHN). https://www.clinicaltrials.gov/ct2/show/NCT02291055?term=NCT02291055&rank=1
To find more studies, visit: