Trastuzumab, Cyclophosphamide, and Vaccine Therapy in Treating Patients With High-Risk or Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT00847171 |
Recruitment Status
: Unknown
Verified May 2013 by Sidney Kimmel Comprehensive Cancer Center.
Recruitment status was: Active, not recruiting
First Posted
: February 19, 2009
Last Update Posted
: May 29, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | February 18, 2009 | |||
First Posted Date ICMJE | February 19, 2009 | |||
Last Update Posted Date | May 29, 2013 | |||
Study Start Date ICMJE | December 2008 | |||
Estimated Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00847171 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Clinical benefit as assessed by rate of progression-free survival [ Time Frame: 4 years ] | |||
Original Secondary Outcome Measures ICMJE |
Clinical benefit as assessed by rate of progression-free survival | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Trastuzumab, Cyclophosphamide, and Vaccine Therapy in Treating Patients With High-Risk or Metastatic Breast Cancer | |||
Official Title ICMJE | A Safety and Bioactivity Study of Combination Therapy With Trastuzumab, Cyclophosphamide, and an Allogeneic GM-CSF-Secreting Breast Tumor Vaccine for the Treatment of Patients With High Risk/ Metastatic HER-2/Neu- Overexpressing Breast Cancer With No Evidence of Disease | |||
Brief Summary | RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vaccines made from gene-modified tumor cells may help the body build an immune response to kill tumor cells. Giving trastuzumab together with cyclophosphamide and vaccine therapy may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects of giving trastuzumab together with cyclophosphamide and vaccine therapy in treating patients with high-risk or metastatic breast cancer. |
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Detailed Description | OBJECTIVES: Primary
Secondary
Tertiary
OUTLINE: Patients receive trastuzumab (Herceptin®) IV over 30-90 minutes once weekly beginning on day -1 of the first course of vaccination and continuing until the completion of the last course of vaccination. Patients also receive cyclophosphamide IV over 30 minutes on day -1 and allogeneic sargramostim (GM-CSF)-secreting breast cancer vaccine intradermally on day 0. Treatment with cyclophosphamide and the vaccine repeats every 27-42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive a fourth course of cyclophosphamide and vaccine approximately 6-8 months after the first course. Patients undergo delayed-type hypersensitivity testing and blood sample collection at baseline and periodically during study for immunologic laboratory studies. Blood samples are analyzed for serum GM-CSF levels by pharmacokinetic studies and for immune monitoring by ELISPOT and flow cytometry. Skin punch biopsies are also performed periodically and analyzed by IHC. After completion of study treatment, patients are followed periodically. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Breast Cancer | |||
Intervention ICMJE |
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Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Estimated Enrollment ICMJE |
20 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Estimated Study Completion Date | June 2013 | |||
Estimated Primary Completion Date | June 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00847171 | |||
Other Study ID Numbers ICMJE | J0885 CDR0000634155 P30CA006973 ( U.S. NIH Grant/Contract ) JHOC-NA_00021048 JHOC-J0885 |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Sidney Kimmel Comprehensive Cancer Center | |||
Study Sponsor ICMJE | Sidney Kimmel Comprehensive Cancer Center | |||
Collaborators ICMJE | National Cancer Institute (NCI) | |||
Investigators ICMJE |
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PRS Account | Sidney Kimmel Comprehensive Cancer Center | |||
Verification Date | May 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |