MART-1 Antigen With or Without TLR4 Agonist GLA-SE in Treating Patients With Stage II-IV Melanoma That Has Been Removed by Surgery

• Status: Completed
• Trial end date: 2019-04-11
• Target enrollment: 0
• Participant gender: All

Summary

This randomized pilot clinical trial studies melanoma antigen recognized by T-cells 1 (MART-1) antigen with or without toll-like receptor 4 (TLR4) agonist glucopyranosyl lipid A-stable oil-in-water emulsion (GLA-SE) in treating patients with stage II-IV melanoma that has been removed by surgery. Vaccines made from MART-1a peptide or antigen may help the body build an effective immune response to kill tumor cells. Giving TLR4 agonist GLA-SE with MART-1 antigen may help increase the immune response to MART-1a antigen.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Central pathology review submission; Note: this review for MART-1 positivity is mandatory prior to randomization to confirm eligibility

• Human leukocyte antigen (HLA)-A2-positive

• Histologic proof of stage II, III or IV melanoma that has been completely resected or completely treated with ablative therapy (ex: stereotactic body radiosurgery, radiofrequency ablation, cryoablation) 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 any of the vaccine or adjuvant components, including eggs

• Any of the following prior therapies with interval since most recent treatment:

• Chemotherapy =< 4 weeks prior to registration

• Biologic or immunologic therapy =< 4 weeks prior to registration

• Radiation therapy =< 4 weeks prior to registration

• Failure to fully recover from side effects of prior therapy or surgery

• Any of the following:

• 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

• 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) use of immunosuppressive medications including systemic (inhaled, oral, or intravenous [IV]) corticosteroids; Note: use of corticosteroids in doses not exceeding those used for adrenal replacement is acceptable

• History of brain metastases; EXCEPTION: patients with a solitary brain metastasis that has been completely resected, and who have no ongoing central nervous system (CNS) symptoms and an MRI documenting no evidence of CNS disease at least 3 months after resection and within 30 days of registration, are eligible for treatment

• 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 of prior malignancy > 5 years prior to registration, the patient must not be receiving other cancer treatment