Amatuximab for High Mesothelin Cancers

Summary

Background: \- Amatuximab is a cancer treatment drug that targets mesothelin. High levels of this substance are found on some kinds of tumor cells. Lab studies have shown that amatuximab helps the immune system to kill cells that have high levels of mesothelin. However, more research is needed to determine how safe and effective amatuximab is for treating tumors with high levels of mesothelin. Objectives: \- To assess the safety and effectiveness of amatuximab in treating tumors with high levels of mesothelin. Eligibility: \- Individuals at least 18 years of age who have a type of cancer that overexpresses mesothelin. Design: * Participants will be screened with a medical history and physical exam. They will also have blood tests and tumor assessment studies. * Participants will have two intravenous doses of amatuximab several hours apart. Researchers will monitor them closely and do frequent blood draws. On the same day and also within 48 hours of the second dose, participants will have imaging studies. These studies will measure how well the amatuximab is working against the cancer. * Participants will have a third imaging study of the cancer about 1 week after the infusions. * Participants will have a followup visit 2 weeks after receiving amatuximab. This visit will require blood samples. Four weeks after receiving the drug, researchers will review patients symptoms or side effects. This interview can be done in person or by phone.

Timeline

Start

2011-07-12

Primary completion

2013-11-15

Completion

2013-11-15

Publications

• Background Hassan R, Ebel W, Routhier EL, Patel R, Kline JB, Zhang J, Chao Q, Jacob S, Turchin H, Gibbs L, Phillips MD, Mudali S, Iacobuzio-Donahue C, Jaffee EM, Moreno M, Pastan I, Sass PM, Nicolaides NC, Grasso L. Preclinical evaluation of MORAb-009, a chimeric antibody targeting tumor-associated mesothelin. Cancer Immun. 2007 Dec 19;7:20.
• Background Hassan R, Ho M. Mesothelin targeted cancer immunotherapy. Eur J Cancer. 2008 Jan;44(1):46-53. doi: 10.1016/j.ejca.2007.08.028. Epub 2007 Oct 22.
• Background Gubbels JA, Belisle J, Onda M, Rancourt C, Migneault M, Ho M, Bera TK, Connor J, Sathyanarayana BK, Lee B, Pastan I, Patankar MS. Mesothelin-MUC16 binding is a high affinity, N-glycan dependent interaction that facilitates peritoneal metastasis of ovarian tumors. Mol Cancer. 2006 Oct 26;5(1):50. doi: 10.1186/1476-4598-5-50.

Drugs

Indications