Gene Therapy Using Anti-Her-2 Cells to Treat Metastatic Cancer
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|ClinicalTrials.gov Identifier: NCT00924287|
Recruitment Status : Terminated (This study was terminated after the first patient treated on study died as a result of the treatment.)
First Posted : June 18, 2009
Results First Posted : February 14, 2012
Last Update Posted : October 28, 2015
- 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.
- 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.
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer||Drug: in vitro tumor reactive, chimeric T cell receptor (CAR ) gene-transduced PBL plus IV aldesleukin Drug: Cyclophosphamide Drug: Fludarabine Drug: Mesna||Phase 1 Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Study of Metastatic Cancer That Expresses Her-2 Using Lymphodepleting Conditioning Followed by Infusion of Anti-Her-2 Gene Engineered Lymphocytes|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Experimental: Metastatic Cancer
Cancer that has invaded other parts of the body
Drug: in vitro tumor reactive, chimeric T cell receptor (CAR ) gene-transduced PBL plus IV aldesleukin
720,000 IU/kg every 8 hours for a maximum of 15 doses
Other Names:Drug: Cyclophosphamide
60 mg/kg/day x 2 days intravenously (IV) in 250 ml 5% dextrose in water (D5W) with mesna 15 mg/kg/day x 2 days over 1 hour
Other Names:Drug: Fludarabine
25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
Other Name: FludaraDrug: Mesna
3 mg/kg/hour intravenously diluted in a suitable diluent over 23 hours after each cyclophosphamide dose.
- Number of Participants With an Objective Clinical Tumor Regression Response [ Time Frame: 12 days ]Response Evaluation Criteria in Solid Tumors (RECIST) are used to determine objective clinical response. Complete Rresponse (CR) is the disappearance of all target lesions, partial response (PR) is at least a 30% decrease in the target lesions, progressive disease (PD) is at least a 20% increase in the target lesions or appearance of one or more new lesions, and stable disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
- Number of Participants With Adverse Events [ Time Frame: 12 days ]Here are the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.
- Number of Participants With In Vivo Survival of Transfused Cells [ Time Frame: 12 days ]In-vivo survival of infused cells is determined by analysis of the sequence of the variable region of the T cell receptor or flow cytometry (FACS).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924287
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Steven A Rosenberg, M.D.||National Cancer Institute, National Institutes of Health|