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Melanoma Clinical TrialsGeneral Purpose:

Melanoma is a highly-malignant type of skin cancer that will affect over 76,000 individuals in the United States in 2012. If you have been diagnosed with melanoma, you may be interested in pursuing melanoma clinical trials in order to gain access to cutting-edge treatment options that might prove to be more effective than conventional therapies.

If you have not been diagnosed but are at an increased risk of melanoma due to family history, genetic characteristics (e.g., fair skin), high lifetime cumulate exposure to sunlight, or other risk factors, you may be interested in volunteering for a clinical trial designed to evaluate new methods of preventing melanoma.

Regardless of what prompted your search, rest assured that there are numerous melanoma-focused clinical trials currently underway, all of which are designed to gain a better understanding of the disease and discover more effective ways to prevent and treat it.

What Will Melanoma Clinical Trials Be Like?

When participating in a melanoma clinical trial, there are a few basic tests and procedures you may receive; however, the ultimate design of the particular study will determine which specific procedures you will undergo. Some of the following tests and procedures may be used during melanoma clinical trials:

  • Physical exam
  • Detailed personal history of sun exposure and exposure to artificial sources of Melanoma Clinical Trialsultraviolet (UV) radiation, such as tanning beds.
  • Detailed family history of melanoma and other cancer.
  • Detailed history of medication use, current and prior, to document exposure to drugs that increase sensitivity to sunlight or suppress the immune system.
  • Detailed history of dermatologic procedures, such as mole removals or prior scarring or other trauma to the skin.
  • Biopsy
  • Computed tomography (CT scan, or “CAT scan”) or magnetic resonance imaging (MRI) scans. These imaging procedures are non-invasive and provide detailed pictures of areas inside your body.
  • If the study is evaluating a new type of medication or vaccine, blood and/or urine tests may be performed to monitor how your body metabolizes the medication or how effectively your body has responded to the vaccine.
  • Quality of life assessments to evaluate how your cancer is impacting your ability to perform activities of daily living.

Typical Melanoma Clinical Trial Protocol:

Current melanoma-focused research is devoted to finding new and better ways to treat melanoma and prevent it from spreading to other sites of the body. In addition, since most Melanoma Clinical Trialsskin cancers can be prevented, a great deal of research centers on new and more effective ways to educate the public about the importance of sun protection, as well as the usefulness of regular skin exams. Possible examples of melanoma clinical trials include the following:

  • A study designed to conduct genetic testing among healthy individuals with a family history of melanoma in order to determine the frequency of specific gene mutations known to increase an individual’s risk of developing melanoma.
  • A study designed to investigate if early testing of lymph node DNA can help to identify melanomas that have begun to spread and better target which patients can benefit from further treatment.
  • A clinical trial that compares the use of standard chemotherapy alone versus standard chemotherapy plus a targeted therapy that works to boost the body’s natural immune response to melanoma cells to determine a) which treatment is more effective and b) if one produces more side effects than the other.
  • A clinical trial to determine if a newly-developed anti-melanoma vaccine given to patients with advanced melanoma can help to increase the amount of the tumor that shrank in response to standard chemotherapy and the length of time before it starts to grow again.

A brief word about randomized trials and placebos:

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug Melanoma Clinical Trialscompared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug is being evaluated for the first time in a specific cancer, the investigational treatment might be compared to a placebo alone. In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

This is rarely done in cancer clinical trials; however it may occasionally be necessary from a scientific standpoint. Placebo-only trials will only be done when ethically appropriate and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment.

It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular type of cancer and clinical situation.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors, including your disease stage, treatment history, and a variety of clinical findings. Therefore, it is important to know many details pertaining to your specific diagnosis when searching for clinical trials. Examples of the details you will want to have on hand include:

  • The name, location, size, stage, and cell type of your cancer, as well as the locations of any metastases you have. Also know these details for any prior cancer you have had.
  • Know your performance status, which estimates how well you perform normal activities of daily living. Examples: Karnofsky Performance Scale (KPS) and the ECOG scale.
  • Know your treatment history, including chemotherapy, radiation therapy, immunotherapy, and/or surgery.
  • Know your blood cell counts, liver function test results, and kidney function test results.

Suggested Search Terms Related to Melanoma:

“melanoma treatment,” “melanoma chemotherapy,” “melanoma radiation therapy,” “melanoma management,” “melanoma surgery,” “advanced melanoma,” “melanoma screening,” “metastatic melanoma,” “melanoma genetics,” “melanoma family history,” and “melanoma symptoms.”

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