Full Title
ADI-PEG 20 or Placebo Plus Gemcitabine and Docetaxel in Previously Treated Subjects with Leiomyosarcoma (ARGSARC): A Randomized, Double-Blind, Multi-Center Phase 3 Trial (WIRB)Purpose
Leiomyosarcoma is a type of cancer that forms in smooth muscle. Researchers want to see if adding ADI-PEG 20 to the usual chemotherapy for leiomyosarcoma works better than chemotherapy alone. The people in this study have leiomyosarcoma that keeps growing despite treatment.
Amino acids are the building blocks of proteins. ADI-PEG 20 breaks down an amino acid called arginine. Some cancer cells need arginine to grow. Giving ADI-PEG 20 may block the growth of those cancer cells and make tumors shrink.
If you join this study, you will get the standard chemotherapy drugs gemcitabine and docetaxel with ADI-PEG 20 or a placebo. A placebo is an inactive drug. ADI-PEG 20 is given as an injection and the chemotherapy drugs are given intravenously (by vein).
Who Can Join
To join this study, there are a few conditions. You must:
- Have leiomyosarcoma that keeps growing after prior treatment with anti-cancer drugs, specifically an anthracycline medication (such as doxorubicin).
- Have recovered from the serious side effects of previous therapies.
- Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
- Be age 18 or older.
Contact
For more information or to see if you can join this study, please call Dr. Viswatej Avutu’s office at 646-888-6860.