GRN1005 for Brain Metastases From Breast or Lung Cancer
Status:
Withdrawn
Trial end date:
2014-08-11
Target enrollment:
Participant gender:
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.