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Participants With HER2-Negative, Metastatic Breast Cancer Sought for Vaccine Trial

Start Date: July 2009

Written By Nicole Katze, MA, Writer and Editorial Coordinator
Reviewed By Sylvia Adams, MD

This trial is currently seeking participants

Researchers at The Sidney Kimmel Comprehensive Cancer Center of Johns Hopkins University, Baltimore, Md., seek 60 participants with HER2-negative, metastatic breast cancer for a phase II clinical trial. The trial is testing the safety and effectiveness of the chemotherapy medicine cyclophosphamide (Cytoxan) plus vaccine therapy, with or without the addition of trastuzumab (Herceptin).

Background

Cancer vaccines that are allogeneic are made from killed tumor cells taken from one person and used in another person to treat a tumor with similar qualities. Scientists believe this kind of vaccine may help boost the body’s immune-system response to killing tumor cells by modifying the cells to release granulocyte-macrophage colony-stimulating factor (GM-CSF), a protein that helps drive processes that fight infection in the body.

Medicines like cyclophosphamide and trastuzumab may increase the number of immune cells, cells that protect the body from infection and disease. The more immune cells present, the stronger the attack on cancer cells is expected to be.

This study is exploring how safe and effective combining cyclophosphamide and the allogeneic, GM-CSF-secreting breast cancer vaccine is in treating metastatic breast cancer compared with the same combination given along with trastuzumab.

Goals

The researchers will measure, in both arms, the side effects caused by the treatment, as well as the impact of treatment on progression-free survival (PFS), the time from the start of treatment until the cancer grows or spreads. Importantly, a detailed analysis of the immune system’s response will be performed, with the hope that more information will help in the discovery of even more effective immune therapies.

Structure 

Participants will be randomly assigned to one of two treatment arms (groups).

  • Arm I will receive cyclophosphamide by vein over 30 minutes on the first day of treatment, followed by an injection of the GM-CSF vaccine into the skin on the second day. This cycle is repeated every 4– 6 weeks for 3 courses. At 6 – 8 months, participants receive a final vaccine injection.
  • Arm II will follow the same treatment cycle, but will receive trastuzumab by vein over 30 – 90 minutes on the same day that cyclophosphamide and the vaccine are given. At 6 – 8 months, they too will receive a final vaccine injection.

Goals will be assessed at 6 months.

Eligibility

You may be eligible for this trial if you:

  • Are 18 years or older and have metastatic breast cancer
  • Have a tumor that is HER2-negative
  • Have no uncontrolled health conditions
  • Have normal blood counts and heart function
  • Finished treatment with chemotherapy, radiation therapy, or biologic therapy at least 28 days before enrollment
  • Finished any other clinical trial or treatment with oral steroids at least 28 days before enrollment
  • Have not been treated with an allogeneic GM-CSF vaccine before
  • Do not have an autoimmune disease requiring treatments that suppress, or weaken, your immune system
  • Do not have an active infection, including HIV

For more information on eligibility, talk with your doctor and see NCT00971737 on clinicaltrials.gov.

Study Locations

This study is beingheld only at The Sidney Kimmel Comprehensive Cancer Center of Johns Hopkins University in Baltimore, Md. Contact the clinical trials office at (410) 955-8804, or jhcccro@jhmi.edu for enrollment information.

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