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About
RATIONALE: Vaccine therapy may help the body build an effective immune response to kill tumor cells.
PURPOSE: This randomized clinical trial is studying how well vaccine therapy works in treating patients with advanced melanoma.
Full description
OBJECTIVES:
OUTLINE: Patients are randomized to 1 of 10 arms.
All patients receive primary vaccine comprising melanoma multipeptides and tetanus toxoid helper peptide emulsified in incomplete Freund's adjuvant, half of the volume subcutaneously (SC) and the other half intradermally (ID), 6 times over 7 weeks on days 1, 8, 15, 29, 36, and 43. Vaccines are administered in a single skin location on an extremity clinically uninvolved with melanoma. A replicate vaccine site is identified for each patient for skin biopsy with or with out replica vaccine administration.
Tissue biopsies are examined by reverse transcriptase-PCR, IHC, protein analysis, flow cytometry, and western blot. Blood samples are collected periodically and examined by ELIspot assay, tetramer staining, and proliferation assay.
After completion of study therapy, patients are followed annually.
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed melanoma that meets one of the following criteria:
Persistent or metastatic disease allowed if RECIST criteria for measurable disease is not met
Multiple primary melanomas allowed
Prior or concurrent metastasis from a cutaneous, mucosal, ocular, or unknown primary site allowed
No clinically detectable melanoma deemed likely by the investigator to require intervention during the first 12 weeks of the study that would require premature discontinuation (e.g., untreated bone metastases at risk for fracture or rapidly progressive low-volume disease)
Brain metastases allowed if all of the following criteria are met:
At least two intact axillary and/or inguinal lymph node basins
Prior lymph node biopsy allowed if lymphoscintigraphy demonstrates intact drainage to a node in that basin
HLA-A1, -A2, -A3, or -A11 positive
Either eligible for, but refused interferon therapy OR not a candidate for interferon therapy for the following reasons:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
Prior peptide vaccines (including MELITAC 12.1 and similar vaccines) or non-peptide vaccines allowed
At least 1 week since prior stereotactic radiotherapy, such as gamma knife
No influenza vaccine ≥ 2 weeks before, during, and ≥ 2 weeks after completion of study therapy
More than 4 weeks since prior and no concurrent use of any of the following:
Systemic cytotoxic chemotherapy (6 weeks for nitrosoureas)
Radiotherapy
Other experimental therapy
Agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents and topical steroids)
Allergy desensitization injections
Systemic corticosteroids, administered parenterally or orally
Inhaled steroids (e.g., fluticasone propionate [Advair® or Flovent®] or triamcinolone acetonide [Azmacort®])
Growth factors (e.g., sargramostim [GM-CSF], filgrastim [G-CSF], or epoetin alfa)
Interferon therapy
Aldesleukin or other interleukins
Street drugs
At least 1 month since prior and no other concurrent investigational drugs or therapy
At least 12 weeks since prior melanoma vaccine for patients who have recurred or progressed either after or during treatment with vaccine
Primary purpose
Allocation
Interventional model
Masking
45 participants in 10 patient groups
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Data sourced from clinicaltrials.gov
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