Protocol
RST921: A Randomized Phase II Trial of Bevacizumab (Avastin) and Temsirolimus (Torisel) in Combination with Intravenous Vinorelbine and Cyclophosphamide in Patients with Recurrent/Refractory Rhabdomyosarcoma
Diseases
Solid Tumor : Recurrent or refractory rhabdomyosarcoma
Description
Rhabdomyosarcoma, a tumor of the skeletal muscle is the most common soft tissue sarcoma of childhood. Patients with tumors that have come back after treatment or do not respond to treatment have a poor outcome. At this time, there is no standard treatment for patients who have rhabdomyosarcoma that is not responding to treatment or has come back after treatment. Treatment options are based on many factors. These include where in the body the cancer is and what type of treatment the patient had before. This study is testing 2 experimental drug combinations in the hope of finding a new therapy for fighting this type of cancer. The 2 drug combinations are: Vinorelbine and cyclophosphamide with bevacizumab and Vinorelbine and cyclophosphamide with temsirolimus.
The drugs vinorelbine and cyclophosphamide were given safely in a study to treat a small number of children with recurrent or refractory sarcomas, including rhabdomyosarcoma. In this study, the doctors want to find out if giving bevacizumab or temsirolimus along with vinorelbine and cyclophosphamide is safe. They also want to see how effective each of the 2 drug combinations is against recurrent or refractory rhabdomyosarcoma. Bevacizumab and temsirolimus are experimental anticancer drugs that have not yet been approved by the Food and Drug Administration for use in treating rhabdomyosarcoma that is not responding to treatment or has come back after treatment. Bevacizumab and temsirolimus work differently than the drugs vinorelbine and cyclophosphamide. As tumors grow, they need new blood vessels to grow with them in order to receive nutrients and survive. Bevacizumab works by blocking the growth of blood vessels, including blood vessels in tumors. Temsirolimus blocks a protein called mTOR. mTOR is involved in tumor growth, including the growth of blood vessels.
Objectives
- To find out what effects (good and bad) bevacizumab, given with vinorelbine and cyclophosphamide, has on children and young adults with recurrent or refractory rhabdomyosarcoma
- To find out what effects (good and bad) temsirolimus, given with vinorelbine and cyclophosphamide, has on children and young adults with recurrent or refractory rhabdomyosarcoma
- To compare the effects of treatment with vinorelbine, cyclophosphamide and bevacizumab against the effects of treatment with vinorelbine, cyclophosphamide and temsirolimus
Eligibility
- Patient must be less than 30 years of age at the time of study enrollment.
- Patients with first relapse or progression of rhabdomyosarcoma are eligible.
- Female patients who are pregnant are ineligible since fetal toxicities and teratogenic effects have beennoted for several of the study drugs.
- Lactating females are not eligible unless they have agreed to discontinue breastfeeding.
For the current eligibility status of this clinical study, referring physicians must contact St. Jude Children's Research Hospital at 1-866-2ST-JUDE (1-866-278-5833).
Contact
Alberto Pappo, MD
St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105 USA
Voice: 1-888-226-4343 or 901-595-4055
Fax: 901-595-4011
Referring or consulting physicians only: protocolinfo@stjude.org
For all other inquiries about St. Jude Children's Research Hospital studies: info@stjude.org
The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.