image

HER2-Specific T Cells in Treating Patients With HER2-Positive Refractory or Metastatic Sarcoma

RETURN TO LIST OF TRIALS
 


Purpose: This is a two part trial. First part is to see if the patient's own immune cells can be made to fight the tumor. To even get there the tumor cells have to be HER2 (a specific protein) positive. These cells may (and might not deopending on the specific situation and the patient's state) be then given back to the patient to see if it does help.
Authoritative site for this trial:  https://clinicaltrials.gov/ct2/show/NCT00902044
What is the treatment?   HER2-specific T cells are the focus of the therapy. However, the therapy also includes the following chemotherapy: Fludarabine and Cyclophosphamide
Is there a chance you'll get a placebo?  No
How old do you have to be?   No age restriction
What phase study is this?  A Phase I study. That it is a test to see how safe or toxic the treatment is. At this phase, there is not a lot of evidence in humans trials that this therapy works.
What includes you in trial?
  • You have been diagnosed with HER2-positive sarcoma or metastatic HER2-positive sarcoma that has not responded to other treatment or is not treatable by surgical removal.
  • You have recovered from the short-term toxic effects of all earlier chemotherapy at least 4 weeks before entering this study.
  • Normal heart, lung and liver function
  • Your blood counts are at least near normal (or can be normalized by short-term treatment including transfusion)
  • Your blood counts are at least near normal (or can be normalized by short-term treatment including transfusion)
  • Your doctors expect that you will live at least 6 more weeks
  • Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the cytotoxic T lymphocyte (CTL) infusion (your immune blood cells gvien back to you) ; a male partner should use a condom.
  • Your immune cells show enough tumor killing capacity.
  • Full informed consent agreed to and signed.
    		•
    What excludes you from the trial?
  • Currently with a severe infection.
  • HIV positive.
  • Pregnant.
  • Allergies to drugs with mouse proteins.
    		•
    In USA?  Yes
    Sites where the trial is offered:  Houston, Texas
    Contact information: Meenakshi G Hegde
    Phone: 832-824-4840 Email: Meenakshi Hegde