Protocol
10-156
Full Title
A Phase 1b/2 Randomized Phase 2 Study Evaluating the Efficacy of Doxorubicin With or Without a Human Anti-PDGFRa Monoclonal Antibody (IMC-3G3) in the Treatment of Advanced Soft Tissue Sarcoma
Purpose
The purpose of this study is to evaluate the safety and effectiveness of doxorubicin when given with and without an investigational drug called IMC-3G3 in patients with advanced or recurrent soft-tissue sarcoma.
IMC-3G3 is a monoclonal antibody that blocks a protein called platelet-derived growth factor (PDGF) which is often over-active in sarcoma cells. Researchers hope that blocking PDGF will stop tumors from growing.
Doxorubicin is a standard chemotherapy drug that is used to treat sarcoma. Patients in the phase I portion of this study will receive both drugs. Patients in the phase II portion will be randomly assigned to receive doxorubicin with or without IMC-3G3.
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have a confirmed diagnosis of soft-tissue sarcoma that is advanced or has recurred. Patients with Kaposi’s sarcoma may not participate.
- Patients may not have had prior treatment with doxorubicin or other anthracyclines or with any drugs that inhibit PDGF.
- Patients must be able to be ambulatory for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Gary K. Schwartz at 646-888-4158.
Disease(s)
Sarcomas
Sarcomas: Soft Tissue Sarcoma
Locations
Related Diseases
