Clinical Trials

Melanoma Clinical Trials

Although we now have some newly discovered therapies for melanoma treatment, the promise for treating melanoma lies in clinical trials; where new agents are tried out in scientific fashion for approval. It is MIF’s contribution to research to help increase the enrollment of patients to melanoma clinical trials. One reason there is a shortage of patients in melanoma clinical trials is because of the availability of newer effective treatments. We have provided some general information on how clinical trials operate below, along with general questions to ask your medical team when determining if melanoma clinical trials are for you.


The basic structure of clinical trials:

Phase 1
Tests for toxicity and uses increasing doses to find the best dose
Phase 2
The melanoma drug has passed the toxicity testing and is now being tested for effectiveness
Phase 3
Compares the new agent against standard treatment for response rate
Phase 4
The drug is approved by the Food and Drug Administration and still being followed for adverse events and response rates.


Important questions to ask before enrolling in a melanoma clinical trial:

    1. What is the purpose of this study? Who is sponsoring it? How is it reviewed for safety? How many patients will be enrolled?
    2. What kinds of tests and treatments must I go through? What factors might prevent me from entering the trial? Will current therapy preclude my enrollment?
    3. What are the potential side-effects? Get specific details about how the drug is administered and what any relevant studies to date have shown about side-effects and/or response rates.
    4. Will some participants receive a placebo and others get the real thing? What does double-blind mean? Many studies are set up to determine how patients who receive the treatment do by comparison with those who receive nothing. That isn’t fair to the patient and an effective comparator should be offered. Also, many trials are “double-blind”: neither the doctor nor the patient knows what the patient is getting.
    5. Will my insurance pay for this, or the pharmaceutical company? What about scans and other screening tests, who covers that cost? How about housing or travel costs, are they reimbursed?
    6. What happens once the trial is over? Will there be follow up? Will I be told the results of the study?
Please be aware that you can leave the trial at any time. Also, if it is clear that you are getting worse, the trial will end for you. Your medical team may or may not suggest a clinical trial for you, and that may be dependent on what their institution is offering. Here is a glossary of terms to ease confusion: FDA Clinical Trials Glossary

We Can Help:

Deciding on a clinical trial for melanoma is not easy. We at Melanoma International are dedicated to helping you find the best clinical trial to fit your needs by discussing all options, side effects, and locations of trials. Please contact us on our helpline: 1-(866)-463-6663 or 1-(610)-942-3432, or email cpoole@melanomainternational.org for personal assistance.

We are here to empower you with information on melanoma clinical trials and help support you on your decision for melanoma treatment.

Here are some links to search for clinical trials:

Cancer Trials Support Unit
The Cancer Trials Support Unit (CTSU) is an NCI funded program to facilitate participation (by both patients and physicians) in phase III NCI sponsored Cancer treatment trials.

ClinicalTrials.gov
National Institutes of Health search site for clinical trials, and one of the best search engines for finding a clinical trial nationally or internationally

ClinicalTrialsRegister.eu
European source for clinical trials

 


Updated: September 1, 2018