GRN1005 for Brain Metastases From Breast or Lung Cancer

Summary

Background: \- Brain metastases are cancer cells that have spread to the brain from primary cancers in other organs. These tumors can be removed surgically. However, researchers are trying to find better ways to treat brain metastases. A new drug, GRN1005, has been designed to cross into the brain and deliver the cancer treatment drug paclitaxel to treat tumors. Researchers want to see how well GRN1005 works on brain metastases from breast or lung cancer. Objectives: \- To test the safety and effectiveness of GRN1005 in treating brain metastases from breast or lung cancer. Eligibility: \- Individuals at least 18 years of age who have breast or lung cancer that has spread to the brain. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. Tumor tissue samples may also be collected. Imaging studies will also be performed. * Participants who have breast cancer will be divided into two groups. Those whose cancer contains the HER2 protein will be treated with the drug Herceptin as well as GRN1005. Those without HER2 will have only GRN1005. * Participants who have lung cancer will also have only GRN1005. * All participants will have two doses of GRN1005, each 3 weeks apart. On the day the second dose of GRN1005 is given, participants will undergo surgery to remove the brain tumors. * Treatment will be monitored with frequent blood tests and imaging studies.

Timeline

Start

2012-08-29

Primary completion

2014-08-11

Completion

2014-08-11

Publications

• Background Platta CS, Khuntia D, Mehta MP, Suh JH. Current treatment strategies for brain metastasis and complications from therapeutic techniques: a review of current literature. Am J Clin Oncol. 2010 Aug;33(4):398-407. doi: 10.1097/COC.0b013e318194f744.
• Background Steeg PS, Camphausen KA, Smith QR. Brain metastases as preventive and therapeutic targets. Nat Rev Cancer. 2011 May;11(5):352-63. doi: 10.1038/nrc3053. Epub 2011 Apr 7.
• Background Lagerwaard FJ, Levendag PC, Nowak PJ, Eijkenboom WM, Hanssens PE, Schmitz PI. Identification of prognostic factors in patients with brain metastases: a review of 1292 patients. Int J Radiat Oncol Biol Phys. 1999 Mar 1;43(4):795-803. doi: 10.1016/s0360-3016(98)00442-8.

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