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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Stage IV Melanoma
- Sponsor
- Masonic Cancer Center, University of Minnesota
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Median Time of Progression-free Survival
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
RATIONALE: Aldesleukin may stimulate the white blood cells to kill tumor cells. Vaccines may help the body build an effective immune response to kill tumor cells. Giving aldesleukin together with vaccine therapy may kill more tumor cells. It is not yet known whether aldesleukin is more effective with or without vaccine therapy in treating melanoma.
PURPOSE: This randomized phase II trial is studying how well aldesleukin works when given with or without vaccine therapy in treating patients with stage IV melanoma.
Detailed Description
OBJECTIVES: Primary * To compare the progression-free survival of patients with stage IV melanoma treated with aldesleukin with vs without allogeneic large multivalent immunogen melanoma vaccine LP2307. Secondary * 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 patients. 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 unacceptable toxicity. * 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 I. 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Stage IV melanoma.
- •Prior systemic chemotherapy, immunotherapy, or biological therapy is allowed if at least 4 weeks since last treatment. Patient must recover from the acute toxic effects of the treatment prior to study enrollment.
- •Disease status must be that of measurable or nonmeasurable disease as defined by Solid Tumor Response Criteria (RECIST)
- •Karnofsky performance status \>70% (Eastern Cooperative Oncology Group 0-1)
- •Age 18 years or older
- •Adequate organ function within 14 days of study enrollment including the following:
- •Adequate bone marrow reserve: absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 10\^9/L, platelets ≥100 x 10\^9/L, and hemoglobin ≥ 10 g/dL
- •Hepatic: bilirubin \< 3 times the upper limit of normal (× ULN), aspartate transaminase (AST) \< 3 × ULN
- •Renal: creatinine ≤ 2.0
- •Must share at least one class I HLA allele with the HLA-type SK23-CD80+ cell (class I alleles (A1, A2, B7, B8, C7))
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Median Time of Progression-free Survival
Time Frame: From Date of Randomization to Date of Disease Progression or Last Contact - up to 2 years.
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.
Secondary Outcomes
- Clinical Response of Lesion(s)(Month 2 through Month 12)
- Overall Survival at 2 Years(2 Years)
- Overall Survival at 1 Year(1 Year)
- Immune Response(48 hours After Study Medication)