Melanoma (Skin) Clinical Trial
Official title:
Phase II Evaluation of Peptide Immunization and LMB-2 in Metastatic Melanoma
RATIONALE: The LMB-2 immunotoxin can find tumor cells and kill them without harming normal
cells. Vaccines made from peptides may help the body build an effective immune response to
kill tumor cells. Giving LMB-2 immunotoxin together with vaccine therapy may kill more tumor
cells.
PURPOSE: This phase II trial is studying how well giving LMB-2 immunotoxin together with
vaccine therapy works in treating patients with metastatic melanoma that cannot be removed
by surgery.
Status | Completed |
Enrollment | 26 |
Est. completion date | July 2008 |
Est. primary completion date | June 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of metastatic melanoma - Unresectable disease - Progressive disease while receiving standard therapy (e.g., interleukin-2 or dacarbazine) - HLA-A0201 positive - Measurable disease - The following are not allowed: - Resectable local/regional disease - Patients whose serum neutralizes LMB-2 in tissue culture, due either to antitoxin or antimouse-immunoglobulin G antibodies (> 75% of the activity of 1 ug/mL of LMB-2) - Received LMB-2 on another trial PATIENT CHARACTERISTICS: - ECOG performance status 0-2 - Life expectancy more than 3 months - WBC = 3,000/mm^3 - Absolute lymphocyte count > 500/mm^3 - Platelet count = 90,000/mm^3 - Bilirubin = 2.0 mg/dL (= 3.0 mg/dL for patients with Gilbert's syndrome) - AST and ALT = 2.5 times normal - Albumin = 3.0 g/dL - No hepatitis B surface antigen or hepatitis C positivity - Creatinine = 1.4 mg/dL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No ongoing or active infection - Ejection fraction = 45% by echocardiogram or thallium stress test (for patients > 50 years of age OR who have a history of cardiovascular disease) - LVEF = 45% - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - No psychiatric illness or social situation that would preclude study compliance - No other uncontrolled illness - No known HIV positivity - No autoimmune disease - No immunodeficiency - No other malignancies - Must be willing to undergo leukapheresis PRIOR CONCURRENT THERAPY: - See Disease Characteristics - More than 12 weeks since prior monoclonal antibody therapy - More than 3 weeks since prior and no concurrent systemic therapy for cancer - No concurrent chronic anticoagulant therapy - No concurrent systemic steroid therapy |
Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | NCI - Surgery Branch | Bethesda | Maryland |
United States | Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institutes of Health Clinical Center (CC) | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective clinical response rate | No | ||
Secondary | Changes in levels of CD4+, CD25+ regulatory T cells | No | ||
Secondary | Ability of LMB-2 to augment peptide vaccination | No | ||
Secondary | Toxicity | Yes |
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