Recurrent Melanoma Clinical Trial
Official title:
A Randomized Phase II Trial to Determine the Immune Response to a Mutated gp100 Melanoma Peptide (209-2M) Vaccine in HLA-A2 Positive Patients With a >1mm Melanoma on Initial Biopsy
This randomized pilot phase II trial studies how well vaccine therapy works in treating human leukocyte antigen class 1 histocompatibility, A-2 (HLA-A2) positive patients with melanoma. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells.
Status | Completed |
Enrollment | 26 |
Est. completion date | |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 17 Years and older |
Eligibility |
Inclusion Criteria: - Patients must have histologically confirmed primary melanoma of Breslow thickness 1.0-4.0 mm; patients who have had only their initial biopsy are preferred; however, those who have already undergone a wide local excision are also eligible; patients may be enrolled up to three months after their wide local excision - Patients whose melanoma is > 4.0 mm thick who have positive or negative regional lymph nodes are also eligible - After accrual to the original 26 patient goal, all patients must be enrolled prior to sentinel lymph node dissection; patients with previous lymph node dissection will not be eligible - Patients must be HLA typed and be shown to be HLA-A2.1+ by either serologic techniques, flow cytometry, or molecular techniques - Patients must be ambulatory with good performance status (Karnofsky performance status [PS] 80-100) - White blood cell (WBC) >= 3500/mm^3 - Platelets (Plt) >= 100,000/mm^3 - Hemoglobin >= 9 gm/100 ml - Serum creatinine =< 2 mg/dl - Total bilirubin =< 2.0 mg/dl - Patients must have recovered from any effects of major surgery and be free of significant systemic infection - Patients must be negative for human immunodeficiency virus (HIV) antibody by enzyme-linked immunosorbent assay (ELISA) (or negative by Western blot if ELISA is positive) if they are considered to be at high risk; others do not require serologic testing if there are no symptoms or risk factors for HIV disease - Women of childbearing potential must have a negative pregnancy test and should avoid becoming pregnant while on treatment - Patients must give written informed consent prior to initiation of therapy; patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy Exclusion Criteria: - Patients must not have clinically detectable distant metastases - Patients who require or are likely to require systemic corticosteroids for intercurrent illness - Patients with any significant medical disease other than the malignancy (e.g. chronic obstructive pulmonary disorder [COPD], patients with ascites or pleural effusions) which in the opinion of the investigator would significantly increase the risk of immunotherapy - Patient should be free of any other cancers or deemed at low risk for their recurrence |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Providence Portland Medical Center | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in T cell immunity to gp100 peptide and to E7 12-20 papilloma virus peptide | Frequency measures obtained from each assay will be transformed to (common) logs for purposes of analysis. Repeated measures analyses will be performed on longitudinal data to assess patients' immune response profiles over time. Comparability of assay methods will be assessed with correlation analyses, regression analyses, standard parametric and nonparametric tests, and agreement methods. | Baseline to 6 months | No |
Primary | Gp100 responses | Within subject analyses will be performed to determine differences in (self) gp100 responses to (foreign) HPV protein responses. | Up to 6 months | No |
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