Gene Therapy Using Anti-Her-2 Cells to Treat Metastatic Cancer
Status:
Terminated
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
Summary
Background:
- Human epidermal growth factor receptor-2 (Her-2) is a gene found in both normal cells
and cancer cells. Extra copies of the gene (overexpression) can cause too many Her-2
proteins (receptors) to appear on the cell surface and cause tumors to grow.
- An experimental procedure developed for treating patients with cancer uses blood cells
found in their tumors or bloodstream. The cells are genetically modified using the
anti-Her-2 gene and a type of virus. The modified cells (anti-Her-2 cells) are grown in
the laboratory and then given back to the patient to try to decrease the size of the
tumors. This is called gene therapy.
Objectives:
- To determine whether advanced cancers that overexpress Her-2 can be treated effectively
with lymphocytes (white blood cells) that have been genetically engineered to contain an
anti-Her-2 protein.
Eligibility:
- Patients 18 years of age and older with metastatic cancer (cancer that has spread beyond
the original site) and for whom standard treatments are not effective.
- Patient's tumor overexpresses Her-2.
Design:
- Workup with scans, x-rays and other tests.
- Leukapheresis to obtain cells for preparing the anti-Her-2 cells for later infusion.
- 1 week of chemotherapy to prepare the immune system for receiving the anti-Her-2 cells.
- Infusion of anti-Her-2 cells, followed by interleukin-2 (IL-2) treatment. The cells are
given as an infusion through a vein. IL-2 is given as a 15-minute infusion through a
vein every 8 hours for a maximum of 15 doses.
- Periodic follow-up clinic visits after hospital discharge for physical examination,
review of treatment side effects, laboratory tests and scans every 1 to 6 months.