Phase II Study of Allo LMI Vaccine With IL-2 for Stable Metastatic Breast Ca
RATIONALE: Vaccines may help the body build an effective immune response to kill tumor cells. Aldesleukin may stimulate the white blood cells to kill breast cancer cells. Giving vaccine therapy together with aldesleukin may be a more effective treatment for metastatic breast cancer.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with aldesleukin works in treating women with metastatic breast cancer.
|Breast Cancer||Biological: allogeneic large multivalent immunogen breast cancer vaccine Biological: aldesleukin||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Allogeneic Large Multivalent Immunogen (LMI) Vaccine and IL-2 for the Treatment of Stable Metastatic Breast Cancer|
- Disease Response [ Time Frame: Beginning at 2 months ]Percentage of patients achieving complete response, partial response, or disease stabilization as assessed by RECIST criteria
- Immune response [ Time Frame: 48 hours ]Immune responses will be assessed by DTH responses to LMI, IFN-gamma production by CD8+ T cells using the ELISPOT assay, and CD8+ T cell binding to HLA-A2 multimers complexed with breast cancer-derived peptides (multimer analysis).
- Progression-free survival [ Time Frame: Baseline Compared to 1 Cycle and Baseline to After Chemotherapy ]Progression free survival will be measured in months from time of response to time of disease progression as defined by RECIST (appendix II), "at least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s)."
- Overall survival [ Time Frame: 1 Year and 2 Years ]Overall survival at one and two years will be determined by longitudinal follow-up
|Study Start Date:||September 2008|
|Estimated Study Completion Date:||December 2015|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: LMI Vaccination + IL-2
Patients receiving allogeneic large multivalent immunogen breast cancer vaccine and aldesleukin.
Biological: allogeneic large multivalent immunogen breast cancer vaccine
Allogeneic large multivalent immunogen breast cancer vaccine (1 x 10^7, 5-μm silica spheres) will be given as an intradermal injection every 28 days (+/- 3 days). Each vaccine dose will be 0.2 ml.
Other Name: LMIBiological: aldesleukin
Subcutaneous aldesleukin (10 x 10^6 International Units) will be given on day 7 and day 8 after each LMI injection.
- To determine the efficacy of allogeneic large multivalent immunogen (LMI) vaccine and aldesleukin, as defined by clinical benefit rate (percentage of patients demonstrating a complete response, partial response, or disease stabilization as assessed by RECIST criteria), in women with stable metastatic breast cancer.
- To measure the immune response in patients treated with this regimen.
- To determine the progression-free survival of patients treated with this regimen.
- To determine the 1- and 2-year overall survival rates in patients treated with this regimen.
- To determine the safety profile and toxicity of this regimen in these patients.
OUTLINE: Patients receive allogeneic large multivalent immunogen (LMI) vaccine intradermally on day 1 and aldesleukin subcutaneously on days 7 and 8. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 2 courses of vaccine therapy resume the chemotherapy regimen for which prior disease stabilization was achieved. Beginning 2-4 days after completion of chemotherapy, patients receive one dose of LMI vaccine followed by aldesleukin on days 7 and 8. Patients achieving at least stable disease continue to receive LMI vaccine and aldesleukin as above. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Peripheral blood mononuclear cell samples are collected periodically for research studies. Samples are analyzed to assess the frequency of leukocyte subsets (including B cells, T cells, NK cells, and monocytes) via flow cytometry; frequency of T-regs (T cells that express CD4, CD25, and FoxP3); and responses to keyhole limpet hemocyanin and tetanus toxoid via ELISA assay. Other immunological studies are also performed.
After completion of study therapy, patients are followed every 3 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784524
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Douglas Yee, MD||Masonic Cancer Center, University of Minnesota|