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

Overview

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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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 the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Nabil Wasif, 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

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20198322

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