A Randomized Phase II Study of IL-2 With or Without an Allogeneic Large Multivalent Immunogen (LMI) Vaccine for the Treatment of Stage IV Melanoma
- To compare the progression-free survival of patients with stage IV melanoma treated
with aldesleukin with vs without allogeneic large multivalent immunogen melanoma
- To compare the clinical response in patients treated with these regimens.
- To compare the 1- and 2-year survival rates in patients treated with these regimens.
- To determine whether an immune response is generated after vaccination in these
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive allogeneic large multivalent immunogen melanoma vaccine LP2307
intradermally on day 1 and aldesleukin subcutaneously (SC) on days 7 and 8. Treatment
repeats every 28 days for 12 courses in the absence of disease progression or
- Arm II (control): Patients receive aldesleukin SC on days 1 and 2. Treatment repeats
every 28 days for 12 courses in the absence of disease progression or unacceptable
toxicity. Patients with disease progression may cross over and receive treatment on arm
Patients undergo blood sample collection periodically for correlative laboratory studies.
Samples are analyzed for immune responses to keyhole limpet hemocyanin and tetanus toxoid
(control antigens) by ELISA assay; IFN-γ production by CD8 T cells in response to
melanoma-derived peptides by ELISpot assay; delayed-type hypersensitivity response to
vaccination; and frequency of peripheral blood lymphocytes, including T cells, B cells, NK
cells, and monocytes, by flow cytometry.
- Arm III Crossover: Patients who have progressive disease on Arm II will be offered
crossover to Arm I provided they continue to meet all study criteria.
After completion of study treatment, patients are followed every 2 months for 1 year, every
3 months until disease progression, and then periodically thereafter.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Median Time of Progression-free Survival
Progression free survival (PFS) was measured in months from date of randomization to date of disease progression, or date of death. For patients who died without tumor progression, PFS assumes their deaths are randomly related to tumor progression. Therefore, PFS includes deaths if they came first.
From Date of Randomization to Date of Disease Progression or Last Contact - up to 2 years.
Arkadiusz Dudek, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Masonic Cancer Center, University of Minnesota||Minneapolis, Minnesota 55455|