Vaccine Therapy and Resiquimod in Treating Patients with Stage II-IV Melanoma that has been Removed by Surgery

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 11-000174
    NCT ID: NCT01748747
    Sponsor Protocol Number: MC0972

About this study

This pilot clinical trial studies vaccine therapy and resiquimod in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from peptides may help the body build an effective immune response to kill tumor cell tumor cells. Biological therapies, such as resiquimod, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether Gag:267-274 peptide vaccine and resiquimod are more effective when given together or separately.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Study closed to enrollment

Inclusion Criteria:

  • Central pathology review submission; this review for MART-1 positivity is mandatory prior to registration to confirm eligibility
  • Human leukocyte antigen (HLA)-A2-positive
  • Histologic proof of stage II, III or IV melanoma that has been completely resected with no current evidence of disease, as demonstrated by imaging within 2 months (stage III or stage IV; must be computed tomography [CT], magnetic resonance imaging [MRI], or positron emission tomography [PET]/CT) or 6 months (stage II; may be chest x-ray, CT, MRI, or PET/CT)
  • Absolute neutrophil count (ANC) ≥ 1500 mL
  • Hemoglobin (Hgb) > 10 g/dL
  • Platelets (PLT) ≥ 50,000 mL
  • Aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 x ULN
  • Ability to provide informed consent
  • Willingness to return to Mayo Clinic Rochester for follow-up
  • Life expectancy ≥ 12 weeks
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
  • For women of childbearing potential, a negative serum pregnancy test ≤ 7 days prior to registration
  • Willingness to provide mandatory blood samples for correlative research

Exclusion Criteria:

  • Uncontrolled or current infection
  • Known standard therapy for the patient's disease that is potentially curative or proven capable of extending life expectancy
  • Known allergy to vaccine or adjuvant components
  • Any of the following prior therapies with interval since most recent treatment:
    • Chemotherapy ≤ 4 weeks prior to registration
    • Biologic therapy or immunotherapy ≤ 4 weeks prior to registration
    • Radiation therapy ≤ 4 weeks prior to registration
  • Failure to fully recover from side effects of prior chemotherapy or surgery
  • Any of the following, as this regimen may be harmful to a developing fetus or nursing child:
    • Pregnant women
    • Nursing women
    • Women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.)
  • Known immune deficiency, including human immunodeficiency virus (HIV) infection, as patients with known immune deficiencies will likely not be able to mount an immune response to the study vaccine; in addition, study patients should be naive to the HIV-derived Gag267-274 antigen
  • History of systemic autoimmune disease, as patients with ongoing autoimmunity may be at an increased risk of autoimmune toxicity from the study vaccine
  • Current or recent (≤ 4 weeks prior to registration) use of immunosuppressive medications including systemic corticosteroids; (use of corticosteroids in doses not exceeding those used for adrenal replacement is acceptable)
  • History of brain metastases (even if completely resected)
  • Other active malignancy ≤ 5 years prior to registration; EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: If there is a history or prior malignancy, they must not be receiving other treatment for their cancer

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Svetomir Markovic, M.D., Ph.D.

Closed for enrollment

Contact information:

Research Information Center

800-664-4542

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CLS-20116091

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