Clinical Trial Finder

Inclusion Criteria:

- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Absolute neutrophil count (ANC) > 1500/uL - Platelets >= 120,000/uL - Total bilirubin =< 1.5 mg/dL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x upper limit of normal (ULN) - Serum creatinine =< 1.5 mg/dL (if > 1.5 mg/dL, then creatinine clearance should be > 60 mL/min) - Blood urea nitrogen (BUN) =< 1.5 x ULN - Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria or physical exam - An anticipated overall survival of at least 6 months - Patients of child-bearing potential must agree to use acceptable contraceptive methods (e.g., double barrier) during treatment - Patient or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure - Patients must have undergone/undergo testing for v-raf murine sarcoma viral oncogene homolog B1 (BRAF) V600 mutation status - Patients must have documented, clinically measurable 7th edition American Joint Committee on Cancer (AJCC) stage IIIB/C (bulky nodal and/or in transit disease) or stage IV (distant metastatic) melanoma; patients with brain metastases that have been appropriately treated with surgical resection and/or radiation are eligible for inclusion if they meet the performance status and life expectancy criteria; patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IIIB/C patients must have refused, be ineligible for, or have failed at least one standard of care regional therapy (isolated limb perfusion or infusion) or one non-vaccine based systemic therapy (such as, high dose interleukin [IL]-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen) - Stage IV patients must have refused, be ineligible for, or have failed at least one non-vaccine based systemic therapy (such as, high dose IL-2, dacarbazine/temozolomide, ipilimumab, or participation in a clinical trial); patients who are BRAF V600E mutation positive need to have failed, refused, or be ineligible for at least 2 lines of therapy (vemurafenib plus one other regimen)

Exclusion Criteria:

- Pregnant or nursing female patients - Unwilling or unable to follow protocol requirements - Any condition which in the investigator's opinion deems the patient an unsuitable candidate to receive study drug - Received an investigational agent within 30 days prior to enrollment - Melanoma specific systemic therapy within 30 days of enrollment - A history of AJCC stage IIIB/C or stage IV melanoma but no current clinical evidence of metastatic disease - Known immunosuppressed conditions or active immunosuppressive therapy such as organ transplantation (including bone marrow transplant), high dose steroids, or human immunodeficiency virus (HIV); although a documented negative HIV test is not mandatory for enrollment, patients felt to have a high clinical suspicion for HIV will need to test negative prior to enrollment; use of topicals or eye drops containing steroids is acceptable; inhaled steroids are excluded - Known autoimmune conditions including but not limited to rheumatoid arthritis, multiple sclerosis, lupus, scleroderma, sarcoidosis, vitiligo, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis - Previous history of splenectomy or whole spleen radiation - Systemic immunoglobulin therapy within the last 30 days - Previous history of anaphylaxis or severe allergic reaction to hsp110, gp100, other vaccines, or unknown allergens - Previous or active non-melanoma malignancies (excluding non-melanoma skin cancer or carcinoma in situ of the cervix) diagnosed/treated within the last 5 years - Active uncontrolled bacterial, viral, or fungal infection until these conditions are corrected or controlled

PRIMARY OBJECTIVES:

• I. To estimate the maximum tolerated dose (MTD) and clinically appropriate dose of human heat shock protein (hsp)110-gp100 chaperone complex melanoma vaccine (recombinant hsp110-gp100 chaperone complex vaccine) to recommend a phase II dose in stage IIIB/C and stage IV metastatic melanoma patients.

SECONDARY OBJECTIVES:

• I. To examine the effect of the recombinant human hsp110-gp100 chaperone complex vaccine on measurable clinical tumor.

• II. To determine gp100 and hsp110 specific cell mediated and humoral immune responses elicited by the chaperone complex vaccine.

• III. To determine the effect of dose and serial administration of the chaperone complex vaccine on cell mediated and humoral immune responses.

• IV. To quantify patient characteristics (human leukocyte antigen [HLA] subtype, immune cell function, etc.) that may correlate with immune response to the chaperone complex vaccine.

OUTLINE: This is a dose-escalation study. Patients receive recombinant hsp110-gp100 chaperone complex vaccine intradermally (ID) on days 1, 15, and 43 in the absence of unacceptable toxicity. After completion of study treatment, patients are followed up for 6 months.