Cancer Center of South Florida
 
 
 
Therapy

Chemotherapy

Chemotherapy is a term used to describe the treatment of cancer with drugs.

  • Chemotherapy can be given by mouth, by injection into a vein or an artery, below the skin, into a muscle, into the fluid surrounding the spinal cord and brain, or into the space surrounding your lungs.
  • Cancer cells usually grow more rapidly than normal cells and chemotherapy works by interfering with the growth and reproduction of these cells. Unfortunately, some normal cells also grow rapidly and can be killed by chemotherapy. These normal cells include those found in the bone marrow, mouth, stomach, intestines, hair follicles, and reproductive cells (sperm and egg).
  • Some of the side effects from chemotherapy are the direct result of the anti-cancer drugs on these cells. It is important to remember that chemotherapy produces side-effects in some, but not all patients. Each anti-cancer drug can produce different side effects and these may not be the same in all patients. At times certain odors and environments, i.e., coming in to the clinic may trigger nausea. It is important to remember that most side effects can be managed and severe side effects are uncommon.
Targeted Therapy
  • Targeted therapy is a treatment that blocks specific signals in cancer cells that cause them to reproduce and grow. Known as Small molecules or Monoclonal antibodies, these therapies are selective in nature, which in turn cause less damage to normal cells. Another added benefit of targeted therapy is the decrease in side effects that patients may experience with chemotherapy.

Radiation

Radiation therapy utilizes ionizing radiation to control or cure cancer. It can be used alone or in combination with chemotherapy, surgery, and/or hormonal therapy.

Types of Radiation Therapy
  • External Beam Radiotherapy (EBRT or XBRT) is given outside of the body.
  • Brachytherapy is therapy that is implanted either temporarily or permanently to the affected area.
  • Systemic Radioisotope Therapy is administered orally or intravenously.
Surgery
  • Surgery can be used to remove or debulk a mass. It can be performed before or after chemotherapy treatment is administered.
Clinical Trials

Our Mission: To provide services and programs to improve the lives and treatment of patients with cancer in the South Florida community while enhancing patients quality of life.


We believe that clinical trials are treatment options that should be made available to our patients here in south Florida. It allows patients access to cutting-edge therapies while staying close to home.

What are clinical trials?

Many of the therapies we currently use have been approved by the FDA once they have completed several phases of testing. Phase I studies determine the Maximum Tolerated Dose (MTD) of the study drug that can be tolerated by humans. Usually a small number of patients, 15-30, participate on this trial. Once the safety of the dose has been determined the drug moves on to a Phase II trial. During Phase II, the safety and effectiveness of the study drug is tested in patients with a particular diagnosis, like Breast or Lung cancer. More patients are enrolled on a Phase II trial, usually less than 100. If it is determined the treatment is safe and patients respond to therapy the study drug then is tested in a large Phase III trial. Phase III trials can involve hundreds of patients at many different locations around the world. The last stage is a Phase IV trial. During this phase thousands of patients are enrolled and additional safety and efficacy data are collected. Clinical trials are monitored by Ethical review committees, also known as Institutional Review Boards (IRBs). They review the protocol, informed consents, and other study materials to ensure that the trial will be conducted in an ethical manner. They also monitor the trial while it is open to ensure patient’s safety.

What types of clinical trials are available for people to participate?
  • Prevention studies to help find ways that help diseases from occurring.
  • Prevention studies of finding ways for disease not to progress any further. This may be drug or device clinical tests.
  • Early detection trials
  • Quality of life studies to assist people now and in the future to help deal with their disease
  • Behavioral studies to find ways to avoid/modify behavior that are disease causing
  • Genetic studies to help find ways to detect, diagnose and treat diseases
  • Observational studies – individuals are observed and followed to see how medical decisions are made in every day clinical practice.
What are the steps of getting new drug or devices to be approved by the Food and Drug Administration (FDA) so that they can be prescribed to the public?

The first step is preclinical testing which is testing in animals to see if animals – usually mice prior to being tested in humans. Once animal testing is completed, testing in humans is begun. There are four phases of research in humans:
  • Phase I – this is to evaluate the safety of the drug to see what dose and how often it should be taken. This phase is usually done in normal, healthy volunteers with no real benefit for patient.
  • Phase II – Looks at how well the new drug or device works. It looks at the safety and effectiveness/benefit. This is usually when the drug for a set disease is begun.
  • Phase III – This phase is where a new drug/device is compared to the standard of care to each. If there is equal or greater benefit from the research drug from the present standard of care. This phase is just before FDA approval. The drug/device for genetic use.
  • Phase IV – This phase is after FDA approval when the drug/device is evaluated for effective safety of long-term use.
It will usually take approximately 15 years of testing for a drug/device to be approved by the FDA so that it can be prescribed to the general public.

Why should you or a loved one consider taking part in a clinical trial?

Participation in a clinical trial is voluntary. It is a decision that is made by the patient, their family, physician and the healthcare team. Participating can have its benefits and drawbacks.

Possible benefits are:
  • Clinical trials offer high-quality cancer care. If you are in a randomized study and do not receive the new treatment being tested, you will receive the best known standard treatment. This may be as good, or better than the new approach.
  • If a new treatment is proven to work and you are taking it, you may be among the first to benefit.
  • By looking at the pros and cons of clinical trials and your other treatment choices, you are taking an active role in a decision that affects your life.
  • You have the chance to help others and improve cancer treatment.
Possible drawbacks are:
  • New treatments under study are not always better than, or even as good as, standard care.
  • If you receive standard care instead of the new treatment being tested, it may not be as effective as the new approach.
  • New treatments may have side effects that doctors do not expect or that are worse than those of standard treatment.
  • Even if a new treatment has benefits, it may not work for you. Even standard treatments, proven effective for many people, do not help everyone.
  • Health insurance and managed care providers do not always cover all patient care costs in a study. What they cover varies by plan and by study.
To find out in advance what costs are likely to be paid in your case, check with your insurance company and talk to a doctor, nurse or social worker from the study.
Reference; NIH publication no. 07-6249 (July 2007)

Participating in a Clinical Trial

Patients and their families need to be aware that participating in a clinical trial is voluntary. You will meet with the physician and the study coordinator to review the informed consent. The Informed Consent provides very specific information regarding participation. It includes information about the type of study, the drug(s) to be tested, potential side effects, study specific tests/procedures and timelines, alternative treatment options, Study contacts- Institutional Review Board and Principal Investigator, and finally expectations of you the study patient. Participation can be withdrawn at anytime without negative repercussions from your physician or sponsor company.

Once all of your questions have been answered and the informed consent is signed study specific tests or procedures may be required to determine if you meet all of the eligibility criteria to participate on the trial. Once this has been determined, the study treatment begins. You will be monitored closely by your physician and study coordinator to determine if you are benefiting from the therapy. If follow-up scans and tests determine you are benefiting, treatments will be continued. If it is determined that you are benefiting from the study treatment your physician will stop the treatment and offer you other options.

Where are clinical trials conducted?

The can be done at academic/medical centers, local hospitals and even local doctors offices. They are done in places that physicians are committed to research and who are willing to give their patients options outside of standard of care.

The standard of care if ever evolving due to the fact that physicians are doing research and are finding new and or better ways to treat diseases.

Who can participate in a clinical research trial?

Each study has specific eligibility criteria; most clinical trials will only include people with specific illnesses or disease. The reason for clinical trials being so selective is that the research company is trying to newer and better ways to deal with the given illness. The Cancer Center of South Florida undertakes research trials that involve hematologic and oncologic trials related to issues concerning oncology.

Other Resources:
American Cancer Society www.cancer.org
National Institutes of Health/National Cancer Institute www.nci.org
Clinicaltrials.gov