Protocol
12-188
Full Title
A Phase II Study of Cixutumumab (IMC-A12; IND# 100947) in Combination with Temsirolimus (IND# 61010) in Pediatric Patients with Recurrent or Refractory Solid Tumors(COG ADVL 1221)
Purpose
The purpose of this Children’s Oncology Group study is to evaluate the safety and effectiveness of cixutumumab in combination with temsirolimus in children with sarcomas that have returned despite prior therapy or have stopped responding to standard therapy. Cixutumumab is an investigational drug; temosirolimus is approved for use in adults with kidney cancer, but its use in children is considered investigational.
Cixutumuab inhibits a protein involved in cancer growth called type 1 insulin-like growth factor receptor. Temsirolimus blocks a protein called mTOR, an important regulator of tumor growth. Laboratory studies suggest that these two drugs work well together. Both drugs are given intravenously (by vein).
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must be at least 1 year of age and no older than 30.
- Patients must have a bone sarcoma (osteosarcoma or Ewing¿s sarcoma) or soft-tissue sarcoma (rhabdomyosarcoma or non-rhabdo soft-tissue sarcoma) that has returned despite prior therapy or has stopped responding to standard therapy.
- Patients must be able to be ambulatory for more than half of their normal waking hours.
- There is no limit on the number of prior therapies, but patients must have recovered from the side effects of previous treatments before entering the study.
For more information about this study and to inquire about eligibility, please contact Dr. Leonard H. Wexler at 212-639-7990.
Disease(s)
Primary Bone: Osteosarcoma
Sarcomas
Sarcomas: Osteosarcoma
Sarcomas: Soft Tissue Sarcoma
Locations
Related Diseases
