A Phase II Study of Allogeneic Large Multivalent Immunogen (LMI) Vaccine and IL-2 for the Treatment of Stable Metastatic Breast Cancer
- 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
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of patients achieving complete response, partial response, or disease stabilization as assessed by RECIST criteria
Beginning at 2 months
Douglas Yee, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center, University of Minnesota||Minneapolis, Minnesota 55455|