The purpose of the SYMMETRYSM study is to evaluate the safety and effectiveness of elesclomol (the investigational study drug) in combination with paclitaxel (a chemotherapy drug) for the treatment of metastatic melanoma. The research study will compare the effectiveness of elesclomol when used in combination with paclitaxel versus paclitaxel alone.
What should I know about the study drug?
The investigational medication being evaluated in this study is called elesclomol. Elesclomol is being evaluated in combination with paclitaxel, a drug already approved by the FDA for treating other types of cancer. However, because it has not been approved for the treatment of metastatic melanoma, paclitaxel is considered investigational in this study.
What are the risks and benefits of participating in this study?
Study participants may or may not benefit from the investigational treatment. But, as with any medical research study, it is possible that your recurrent melanoma could become worse or you could experience side effects during the study.
For paclitaxel, the most common side effects are:
- a decrease in white blood cell count leading to an increased risk of infection;
- a decrease in red blood cell count (anemia), which can cause increased fatigue;
- a decrease in platelets, which can result in easy bruising or prolonged bleeding;
- sores in the mouth and throat;
- muscle and/or joint aches; and
- temporary hair loss.
Subjects treated with elesclomol plus paclitaxel generally experienced the same side effects listed above.
You may or may not benefit from participation in this study. But you will receive study-related medical care and evaluations during your participation.
What kinds of medical tests and evaluations are involved with this study?
As a study participant, you will be asked to visit the study clinic several times to undergo a series of study-related medical tests and evaluations. These tests and evaluations will help monitor your safety and measure your progress. They could include, but may not be limited to:
- study-related physical examinations;
- vital sign measurements (temperature, heart rate, and blood pressure);
- electrocardiograms (ECGs), which measure the electrical activity of your heart;
- review of your medical history;
- review of your current medications; and
- collection of blood and urine samples.
Tumor assessments will also be performed every eight weeks or sooner if needed.
What study treatment will I receive as a participant?
Upon study entry, you will be randomly assigned (like the flip of a coin) to one of two treatment groups:
- Group 1 will receive elesclomol (213 mg/m2) in combination with paclitaxel (80 mg/m2).
- Group 2 will receive paclitaxel (80 mg/m2) alone.
You will have an equal chance (50:50) of being assigned to either one of these groups.
Both groups will be given the study medication intravenously (by a needle in the vein). You will receive your first dose of study drug(s) within 14 days of your initial screening visit.
The amount of time you spend in this study may be as little as a few days or as much as several months. It will depend on your disease status and your willingness to continue with the study.
Whom should I contact if I have more questions?
Contact your local study clinic if you have any additional questions.