Clinical Trials

 

 

Mesothelioma Clinical Trials

Studies of experimental or new therapies used on patients are known as clinical trials. Often doctors suggest that a patient participate in a clinical trial or new treatment if it is believed the patient may receive a positive outcome or other positive benefits from the trial. Clinical trials test groundbreaking research that have not yet been approved by the FDA and is still in a testing phase.

Specialists and cancer centers have the ability to connect a patient to a clinical trial. Many times medical breakthroughs have happened but have not yet been formally approved by the lengthy FDA approval process.

Clinical Trial Objectives

Researchers have clinical trials to study new treatments and answer questions such as:

  • Will this treatment be helpful?
  • Does the new treatment work?
  • Does the new treatment cause side effects?
  • Is it better than current treatments?
  • Which patients will find the treatment most helpful?

Why Choose Clinical Trials?

Clinical trials currently being tested around the country may offer the best hope for treating and beating mesothelioma. The trials provide patients access to the latest cutting-edge treatments and this can make a difference in their life expectancy and quality of life.

Progress is made possible by clinical trials. Participating in a mesothelioma trial gives you a better chance at beating cancer and you are also bringing help and hope to future patients by providing valuable information to researchers and doctors.

 

Clinical trials offer the patient:

New Options for Treatment

New treatments begin as clinical trials which includes all of the common treatments now used for mesothelioma

Special Treatment

Patients in clinical trials have access to new and innovative treatments before the general public.

Potential for a Cure

Those who have survived mesothelioma consider themselves to be fortunate enough to have participated.

New treatments may be in the form of radiation, chemotherapy, drugs or multimodal therapy and many health insurances will cover the cost of clinical trials.

What Should I be Concerned About?

 

Participating in clinical trials does have certain risks since the treatments are experimental. There are potential health risks with any clinical trial that a patient should be aware of. There is a risk that the trial treatment may be ineffective and the desired results are not achieved, or there is the potential that the treatment could cause further harm. The patient could also experience unforeseen side effects.

 

Clinical trials can be costly. Patient costs might include routine costs such as hospital visits or hospital stays. Extra costs include any additional tests that may be necessary for the trial. Many insurances will cover the cost for the routine portion of a medical trial.

Recruiting Clinical Trials

An essential part of gaining ground on mesothelioma is through research gathered through clinical trials. Mesothelioma is a rare cancer and there have only been a few new treatment options developed over the last several years. Clinical trials offer the patient access to new treatments and investigational medications which can potentially lead to recovery. There are three categories of clinical trials, prevention, screening, or treatment depending on the focus of the treatment.

Prior to the FDA considering a new treatment, a treatment must go through three phases of testing. There is a fourth phase which is for further research and testing.

Phase 1

This trial includes a small group of 20 or more people in order to analyze the drug or therapy’s safety. The side effects are analyzed and the researchers examine how the body processes the drug. This phase also determines the effective treatment form and dosage.

Phase 2

This trial includes up to 300 patients. It looks at the safety levels of the drug and exactly how effective the treatment or the drug is. It determines how that particular treatment effects a region of cancer and whether or not the results are able to be reproduced in other patients. It may also be compared with a placebo or other treatments.

Phase 3

This phase includes up to several thousand people and it measures how effective the new treatment is compared to the standard treatment approaches. Some of the patients in this group will receive the treatment while others will not. Those who don’t are called the control group. The doctors measure the effects of the treatment against this group. This phase also determines the final dosage amount as well as documents side effects.

N

Phase 4

This is the phase that will test the drug long term in order to determine the effectiveness and safety. This phase usually comes after the FDA has approved a drug or therapy for use.

Participating in a Clinical Trial

 

There are certain things that a patient must consider before participating in a clinical trial and the patient must also provide informed consent. The patient will receive complete information explaining the clinical trial. They then have to sign a waiver that they agree to participate in the trial and can leave the trial at any time. Participating in a study does prevent a patient from getting further treatment.

Each trial has its own set of standards and rules that will determine whether a patient is included or excluded from the trial. Patients are evaluated on an individual basis using specifications related to the test.

These specifications include:

 

  • Age – Some clinical trials may test a specific age group which would disqualify anyone older or younger than the specified age range.
  • Gender – Some clinical trials may apply only to women while others may use male hormones which would exclude women.
  • Current Health – The health of the patient, both current and past can determine whether some patients can be accepted in certain clinical trials. Some won’t accept patients with certain medical histories such as smoking.
  • Mesothelioma Type & Stage – Trials focus on how effective a treatment is on a specific mesothelioma, based on the type or stage of the mesothelioma.

Clinical Trials Available

Patients will be accepted or denied depending on the qualifications, however if they are denied from one trial they may apply to others as there are dozens of clinical trials available.

 

Some top clinical trials include:

 

  • Blocking Mesothelioma Enzymes – PXD101 is a drug that blocks the enzymes needed for cells to grow thus may stop the growth of tumors.
  • Pleural Stem Research – Researchers are targeting the stem cells of mesothelioma by using a signaling pathway inhibitor.
  • Triple-Combo Pleural Treatment – A triple combination of cisplatin, pemetrexed and CPB501 is currently being tested to determine its effectiveness.
  • Anti-Cancer Listeria Vaccine – This Phase l trial focuses on the safety of the immune response of CRS-27, this is a weakened form of Listeria and scientists think that by genetically altering this virus they can stimulate a natural immune response.
  • Tremelimumab for Unresectable Mesothelioma – This phase ll trial is being conducted in several locations and countries. It might give hope for those who have unresectable pleural or peritoneal mesothelioma. Tremelimumab is an immunotherapy treatment drug which is designed to allow the body’s immune system to destroy mesothelioma cells. Tremelimumab has been effective with other cancers but has not been tried on mesothelioma.

Placebo-Controlled Trials

Patients may be fearful of or hesitant to consent to participate in clinical trials. Explaining the clinical trials and what they are about as well as the terminology often helps to alleviate these concerns.

When participating in a placebo controlled trial, half the patients are given the drug that is being tested while the other half of the group is given a placebo. A placebo is a pill that is identical to the drug, but does not contain any medicine. Patients that get the placebo are chosen randomly. It is a double-blind study which means that neither the patients nor the doctors know who received the placebo. Clinical trials are randomized and double-blinded so there won’t be any bias in the results of the study. It also gives each patient a fair chance of getting the non-placebo.

Placebos are used in research trials so that the researchers get faster results. Using placebos are important because they give a comparison between groups allowing the researchers to determine if the experimental treatment is having an effect.

All participants are monitored closely. If their condition gets worse, the doctors will try to determine the reasons for this. Patients can always quit the trial if it is not effective.

Show Sources

Resources:

  1. Hassan, Raffit, M.D., Senior Investigator, National Cancer Institute, interview with Asbestos.com (2013, Oct. 16). Retrieved on 3/23/16.
  2. Verschraegen, Claire, M.D., director, Hematology/Oncology Division, University of Vermont Medical Center, interview with Asbestos.com (2012, Sept. 12). Retrieved on 3/23/16.
  3. http://clinicaltrials.gov/ct2/info/understand#Q19 Retrieved on 3/23/16.
  4. O’Bryne, K and Rusch V. (2006). Malignant Pleural Mesothelioma New York. Oxford University Press. Retrieved on 3/23/16.
  5. How to find a cancer treatment trial.. National Cancer Institute. Retrieved From: http://www.cancer.gov/clinicaltrials/search/treatment-trial-guide. Retrieved on 3/23/16.
  6. Mesothelioma Treatment Clinical Trials.. National Cancer Institute. Retrieved From: http://www.cancer.gov/clinicaltrials/search/results?protocolsearchid=10252427&vers=1. Retrieved on 3/23/16.

Last Modified: Dec 9, 2016 @ 9:03 am

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