A Study Comparing a Vaccine with or without an Autologous Tumor Lysate to Treat Stage III or IV Melanoma to Prevent Recurrence

Overview

  • Study type

    Interventional
  • Study phase

    II
  • 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.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Scottsdale/Phoenix, Arizona: 15-004076
    • Rochester, Minnesota: 15-004076
    NCT ID: NCT02301611
    Sponsor Protocol Number: 15-004076

About this study

The purpose of this study is to compare a vaccine with autologous tumor lysate loaded into yeast cell wall particles that are naturally and efficiently taken up into a patient's dendrite cells to a placebo without the autologous tumor lysate. The vaccine is formulated to treat stage III or IV resected melanoma to prevent recurrence.

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

Inclusion Criteria

  • 18 years or older
  • Eastern Cooperative Oncology Group (ECOG) performance status 0,1
  • AJCC stage III or IV completely resectable melanoma identified before surgery
  • Approximately 1 mg (1 cm3) of accessible and dispensable tumor that will not interfere with pathologic staging
  • Clinically disease-free after surgery
  • Completing SoC adjuvant therapy per NCCN guidelines to include chemotherapy, radiation therapy, and/or biologic therapy as clinically indicated (Consent #2 should be signed as close to completion of SoC as possible but may overlap completion by up to one month.)
  • Vaccinations initiated between 3 weeks and 3 months from completion of SoC multi-modality cancer care
  • Adequate organ function as determined by the following laboratory values
    • ANC ≥ 1,000/μL
    • Platelets ≥ 75,000/μL
    • Hgb ≥ 9 g/dL
    • Creatinine ≤ 1.5 x upper limit of normal (ULN) or Creatinine clearance ≥ 50%
    • Total bilirubin ≤ 1.5 ULN
    • ALT and AST ≤ 1.5 ULN
  • For women of child-bearing potential, agreement to use adequate birth control (abstinence, hysterectomy, bilateral oophorectomy, bilateral tubal ligation, oral contraception, IUD, or use of condoms or diaphragms)
  • Signed informed consent

Exclusion Criteria

  • Evidence of residual disease after surgery and SoC adjuvant therapies
  • Insufficient tumor available to produce vaccine
  • ECOG >2 performance status
  • Immune deficiency disease or known history of HIV, HBV, HCV
  • Receiving immunosuppressive therapy including chronic steroids, methotrexate, or other known immunosuppressive agents
  • Pregnancy (assessed by urine HCG)
  • Breast feeding
  • Active pulmonary disease requiring medication to include multiple inhalers (>2 inhalers and one containing steroids)
  • Involved in other experimental protocols (except with permission of the other study PI)

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

James Jakub, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Rochester, Minn.

Mayo Clinic principal investigator

James Jakub, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

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CLS-20198322

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