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In this module, you take on the role of a program coordinator for a clinical trials team at a major health research facility. Part of your job involves counseling clinical trial participants in order for them to completely understand the research process.
You now have to advise a 16-year old who has been diagnosed with Stage II melanoma (skin cancer) and her parents. You will have to be well aware of clinical trial protocol, the body’s integumentary system, its function and structure, and also skin cancer so that the participant and her parents can make critical decisions.
Your work as a program coordinator for a clinical trials team at a major health research facility involves quite a few different tasks. Each one is important to moving a clinical trial to a successful completion. Although you love your job, some tasks are harder than others. You always think that counseling children who are potential trial participants and their parents is one of the more difficult tasks you do.
Today, you have an appointment with a 16-year old female who has been diagnosed with Stage II melanoma (skin cancer) and her parents. The teen would seem to fit well into a clinical trial being conducted at your facility. You need to review the inclusion/exclusion information provided in the trial description to make sure the teen does indeed fit the criteria and you need to be fully aware of the specific protocol for this clinical trial.
You also need to evaluate the parents to see if they are suitable for involvement of their daughter in this clinical trial. Parents of minor participants play a crucial role in the success of the participation. Both parents and the minor participant need to be fully aware and completely knowledgeable of the specifics involved in clinical trial protocol.
You already know that Jodie and her parents have written some questions for you. Both the parents and the teen are understandably a bit nervous about participating in the trial, but they also understand that she might be helped by the clinical trial.
Parents and teen comments and questions:
1) Parents: Jodie is only 16 years old and she has skin cancer! The doctors told us that tanning beds are being blamed for the rising cases of melanoma in teens. We feel so guilty that we allowed Jodie to tan like that—for homecoming, for prom, and then, just all winter off and on! Will this trial keep the cancer from coming back since she has stopped tanning?
2) Jodie: I already had the skin cancer removed from my stomach, but it had spread already. I have more than 60 stitches where they had to remove lymph nodes that had cancer in them and another 12 stitches where they took the cancer off the skin on my stomach. In one way, I don’t care any more how it looks as long as I don’t have cancer. Worrying about how I looked is what got me this. But, what is going to happen in this trial—more surgery?
3) Parents: Was there anything we should have been looking for so maybe it wouldn’t have spread? She didn’t say anything about a lesion or mole until it was pretty big—we didn’t know it had spread. The doctor told us something about ABCD’s of cancer but we couldn’t even think when they were telling us she had melanoma.
Jodie: I thought tanning beds were safer than the sun! And I didn’t think this mole was anything serious!
4) Parents: This is a Phase III trial. What does that mean? If this is Phase III, did she miss anything by not starting in Phase I?
5) Parents: What happened in Phase I and Phase II?
6) Parents: Are there risks to this trial? Could she get worse by participating in this trial?
7) Parents: When will we know if the drug worked or not?
8) Jodie: Is there anyone else from this city that is in the trial that I might know?
9) Parents: If she gets cancer again, what will happen in the trial? Can she go on a different drug then?
10) Parents: How long will the trial last?
11) Parents: What happens if she can’t take the new medicine?
12) Parents: What happens when the trial is over? Can she still get the medicine?
Clinical Trial Information:
The Safety and Effectiveness of Kadamavar to Prevent Recurrence of Skin Cancer in Patients With a History of Stage II Skin Cancer
Melanoma is one of the three most common types of skin cancer. This type of skin cancer usually results from too much exposure to UV (ultraviolet) rays. The other two common types, basal cell and squamous cell carcinoma, are easily treated if detected early enough. Melanoma is much more serious. Melanomas usually begin as moles on the skin, and if untreated, the cancer spreads to other parts of the body
An estimated 1.3 million new cases of skin cancer will be diagnosed this year. It is the most common cancer in women, ages 25 to 29; one person dies of melanoma every hour in the United States. According to a study by the International Agency for Research on Cancer, seven studies found a 75 % increase in the risk of melanoma for those who used tanning beds before then age of 35. Dermatologists at the University of Michigan Health System say even one trip to the tanning booth can result in DNA damage that can cause skin cancer.
This study tests the safety and effectiveness of Kadamavar in preventing the recurrence of melanoma in patients who have a history of and have been treated for Stage II melanoma.
The effectiveness will be evaluated by examining the patients for the purpose of detecting and confirming the presence of melanoma lesions. The patients will be followed for a period of 6 years.
Participants will be assigned to two treatment arms. The study is randomized, double blind, and placebo-controlled. The investigational group will receive 30 mg Kadamavar, three times daily. The control group will receive an oral placebo.
Participants will be monitored for melanoma recurrence every 12 weeks for 6 years. Any recurrence of melanoma lesions will be treated according to standard care; the patient will return to the trial in the same treatment group.
Sponsors and Collaborators
Center for Drug Evaluation, Research, and Clinical Trials
U.S. Department of Health and Human Services
Center for Biologics Evaluation and Research (CBER)
Center for Drug Evaluation, Research, and Clinical Trials
National Cancer Institute (NCI)
Ages eligible for participation: 15 to 35 years
Genders eligible for participation: Both
Accepts healthy volunteers for participation: No
- Participants must have a history of treatment for Stage II melanoma
- Surgery, radiation therapy, chemotherapy, or therapy using anti-cancer drugs must have ended at least 8 weeks ago.
- Parents or guardians must sign informed consent for minor participants.
- currently not within the age limit as described in the trial information
- currently taking any other anti-cancer therapy, including radiation or chemotherapy
Treatment, Drug Study
To Be Measured: Recurrence of melanoma lesions.
Participants will be monitored for melanoma recurrence every 12 weeks for 6 years. Any recurrence of melanoma lesions will be treated according to standard care; the patients can return to the trial in the same treatment group.
Anti-cancer medications have been shown to reduce the incidences of recurring cancer. This study investigates the effects of a medicinal anti-cancer therapy on melanoma.
- Preliminary effectiveness has been identified in Phase I and Phase II trials.
- A control group using a placebo is also monitored for melanoma recurrence over the course of the trial.
- The study is randomized and double-blind. An oral placebo will be used by the control group.
- All recurring lesions will be excised and biopsied. Participants will return to the trial.
At the end of the 4th year, Phase III will end and final data will be collected. Data will be analyzed and recommendations made prior to Phase IV testing, if it occurs.
Mary Babb Randolph Cancer Center West Virginia University Morgantown, West Virginia
Clinical Trials Research Center University of Virginia Charlottesville, Virginia
University of Colorado Health Science Center Clinical Trials Research Center Denver, Colorado
The Ohio State University College of Medicine Division of Infectious Diseases Columbus, Ohio
Thomas Jefferson University Hospital Clinical Trials Unit Philadelphia, Pennsylvania
University of Southern California Keck School of Medicine Los Angeles, California
Principal Investigator: Lynn Calinger Mary Babb Randolph Cancer Center West Virginia University Morgantown, West Virginia 304.555.5449 email@example.com/clintrial