Purpose of study:
The study doctors would like to see if adding an additional drug combination (vincristine plus irinotecan, or VI) is better than VAC alone. The standard time for radiation therapy to start for most patients with RMS is about 13 weeks after beginning chemotherapy. The study doctors will be looking at the effectiveness of giving radiation therapy earlier in the course of treatment (at 4 weeks instead of 13 weeks). Finally, the study doctors would like to see if a lower dose of cyclophosphamide is as good for treating RMS as the standard dose, but with less toxicity during treatment and afterwards (late effects).
The overall goals of this study are:
Who can participate:
Patient must have Intermediate-risk RMS defined as:
Patients with newly diagnosed embryonal RMS, botryoid or spindle cell variants of embryonal RMS, ectomesenchymoma, or alveolar RMS are eligible for this study.
Additional screening for eligibility will be required.
What will happen during the study:
Subjects (people participating in the study) will get one of two different treatment plans. The treatment plan they get is decided by a process called randomization. Randomization means that the treatment is assigned based on chance. It is a lot like flipping a coin, except that it is done by computer to make sure that there are about the same number of people on each treatment plan of the study. You have an equal chance of being assigned to either treatment plan. A randomized study is the best way to find out if one treatment is better than another. That is why this study is planned the way it is.
Some participants will be randomized to get Regimen A (which is VAC alone) and some will be randomized to get Regimen B (which is VAC plus VI). Some subjects may also have more surgery if it becomes possible to remove more tumor. For all patients on both arms of this study, radiation therapy will start at Week 4.Evaluations (scans) to see how the tumor has changed will be done at Weeks 15, 30 and 43. If at any evaluation your tumor is larger, you will be taken off protocol therapy and you will discuss other treatment options with your doctor.
Treatment on this study will last for about 43 weeks. After you are done with treatment the Study Doctor will ask you to visit the office for follow-up exams every 2-4 months for four years and yearly for 5-10 years.
Who to contact:
Dr. Laura Martin, Principal Investigator