About Clinical Trials
What you should know about participating as a subject in kidney cancer research
One of the options for treatment your oncologist may recommend is a clinical trial. Clinical trials are carefully designed research studies that answer specific questions regarding the effectiveness and safety of new drugs, combinations of drugs, treatments, surgical techniques, or medical devices. Human volunteers with specific health conditions are studied during the trials to determine the efficacy of the new approaches being tested on them. You may want to consider participating in a clinical trial. Often, trials offer access to promising new treatment options before they are generally available.
Some clinical trials are conducted in “controlled” conditions, meaning that one group of participants receives the therapy being tested and another does not. Later, health information from the two groups is compared to determine if the new therapy had any effect. A key process in such clinical trials is “randomization,” in which groups of patients are randomly chosen to receive one treatment or another, thus reducing the chance of bias in the findings.
Clinical trials are conducted by individual institutions (called investigator-initiated trials) or in cooperation with several institutions (called multi-institutional trials) depending on the type of clinical trial and the number of participants that will be enrolled. Clinical trials are organized in cooperation with pharmaceutical companies and with government research organizations such as the National Cancer Institute.
Should You Participate?
Clinical trials have been largely responsible for important advances in the treatment of kidney cancer in recent years. The key to their success is finding suitable human volunteers. By participating, you can obtain access to innovative treatments while helping advance researchers’ understanding of kidney cancer. Volunteers in clinical trials play an essential role in the ongoing quest to find a cure for the disease.
Clinical trials are highly regulated and monitored by the Food and Drug Administration. They cannot begin until rigorous intensive review has taken place, in order to ensure the scientific rationale is valid and that there is a fair balance of patient risk and benefit. Still, despite the careful regulation of clinical trials, you should be aware that there are potential drawbacks in addition to the potential benefits of clinical trial participation.
The National Cancer Institute lists the following possible benefits and drawbacks for individuals considering clinical trials.FN1
You will receive high-quality health care provided by leading doctors in the field of cancer research.
You will have access to new drugs and interventions before they are widely available.
Your health care will be closely monitored, along with any side effects related to the treatment.
You will play a more active role in your own health care.
If the approach being studied is found to be helpful, you may be among the first to benefit.
The trial will provide an opportunity for you to make a valuable contribution to cancer research.
New drugs and procedures may have side effects or risks unknown to the doctors.
New drugs and procedures may be ineffective or may be less effective than current approaches.
Even if a new approach has benefits, it may not work for you.
Some health insurance plans prohibit or restrict coverage for clinical trials. Refer to the section titled “Health Insurance” in the chapter “Living With Cancer Day to Day.”
The fact that you have kidney cancer doesn’t make you automatically eligible for a specific clinical trial. You will have to fit certain requirements of the trial eligibility criteria.
Types of Clinical Trials
Clinical trials fall into one of several categories:
Phase I Trials are the initial studies of a new drug, combination of drugs, or treatment to establish the safest dose. They evaluate the safety of a drug at different doses, and determine if further clinical trials are needed. Most patients participating in Phase I studies have received several types of prior treatment for their cancer. Phase I trials may involve patients with a variety of cancer diagnoses in order to evaluate the safety and determine the appropriate dose and schedule of a drug or treatment in several types of cancer.
Phase II Trials are studies which evaluate anti-tumor activity of a drug or treatment in a more defined group of patients at a standard dose and schedule. These studies involve patients with the same type and stage of cancer, and are very specific regarding the type and number of prior treatments that are allowed. For study entry, some Phase II clinical trials do not allow any prior treatment to have been given, and others will require that a specific type of treatment have been given.
Phase III Trials compare the effectiveness and safety of two or more treatments in a large number of patients, and may involve up to 1,000 patients. These studies are often international studies, based on the number of patients participating. In Phase III studies, new drugs or treatments are compared with a “standard” treatment in kidney cancer.
“Randomized” clinical trials typically are conducted in Phase III trials, and occasionally in Phase II trials. They compare two or more treatments, and may include a placebo group. Randomized trials are conducted on a large number of patients who are directed into one of the treatment categories using random selection techniques, often by computer. This ensures the validity of the trial results.
A “placebo group” may be included in a Phase II or Phase III trial when there isn’t a standard treatment to compare the new drug against. The placebo group receives the same care for cancer and treatment-related symptoms, while allowing the effectiveness of a new therapy to be evaluated. Your oncologist will explain this in more detail if the treatment being recommended involves a placebo group.
Eligibility criteria for clinical trials are carefully identified to ensure that the group of patients treated has the same type, stage, and extent of cancer. These are referred to as “inclusion” or “exclusion” criteria that must be met in order to be eligible for enrollment into a trial. Specific criteria are listed regarding prior surgery and treatment requirements. Some trials require that patients have had a prior nephrectomy (surgical removal of the kidney tumor) while others do not. Additional criteria are used to ensure that the treatment is appropriate based on organ function. These include laboratory, heart, and lung function, and radiology tests to ensure the safety of subjects.
Selecting a Clinical Trial
It is important for you to understand what a clinical trial is, why it is being done, and how you can gather more information regarding the trial you are interested in. Discuss the trial in detail with your oncologist and nurse and be sure to ask any questions you have regarding treatment and possible participation.
At any time, there may be many clinical trials for kidney cancer. You or your doctor can get a list of current clinical trials by using our Clinical Trials Matching Service, powered by EmerginMed®. You may also look at descriptions of clinical trials at the National Cancer Institute website, www.cancer.gov/clinicaltrials.
Before you make any decision, you may want to read “Taking Part in Clinical Trials: What Cancer Patients Need to Know” (NIH Publication 97-4250). This pamphlet can be obtained online or from the Cancer Information Service at 1-800-4-CANCER. You may also want to obtain information about similar therapies and treatment from articles published in medical journals.
Online databases such as MEDLINE contain abstracts of articles published in the journals read by doctors. Your local librarian can help you locate these abstracts, but remember that this information is highly technical and you may want your doctor to review it with you. You should also be aware that because of the time it takes to collect data, prepare a research paper, and have it published, there may not be any published results on the therapy you are considering. In any case, you may want to seek the advice of a kidney cancer specialist before making a final decision to participate in the study. The Kidney Cancer Association can assist you in finding an oncologist who specializes in kidney cancer.
Once you have been given information on treatment options that may include participation in a clinical trial, review the information carefully. Contact the study’s doctor (Principal Investigator) and registered nurse (Research Nurse) with any questions you have regarding the treatment options, possible side effects, and frequency of clinic visits. Your doctors and nurses are very interested in helping you be an active member of the team, and can provide you with information that will allow you to make an informed decision regarding your treatment.
Two kinds of trials — adjuvant and vaccine — may be of particular interest to kidney cancer patients.
Adjuvant trials test the effectiveness of treatments intended to reduce the risk of cancer recurrence. You may participate in a trial to test adjuvant treatment after your primary surgery. These trials are important, as new adjuvant studies are taking place worldwide.
With the introduction of Nexavar (sorafenib tosylate) and Sutent (sunitinib malate), an important new round of clinical trials is now available to kidney cancer patients. Trials with treatments including monoclonal antibodies, vaccines and adoptive immunotherapy may also be available.
Researchers continue to conduct tests on vaccines – which may prevent a recurrence of your kidney cancer. A therapeutic vaccine is made from cells found in your tumor, which contain the genetic code that led to the tumor’s development in the first place. Once you have had surgery to remove the tumor, a portion of it may be used to create a vaccine that is then re-introduced into the body. With the introduction of this vaccine, it is hoped that your body will attack any new cells that re-appear bearing the original tumor’s genetic code. This concept is still “investigational” (being investigated.) More information about specialized clinical trials for kidney cancer is available at the National Cancer Institute website at www.cancer.gov or from the KCA’s Clinical Trials Matching Service.