A Comparison of Matured Dendritic Cells and Montanide® in Study Subjects With High Risk of Melanoma Recurrence

Inclusion Criteria:

Willing and able to give written informed consent
Histologic diagnosis of malignant melanoma, stages IIB-IV in radiologically confirmed complete clinical remission without clinical evidence of disease
At least 4 weeks since surgery prior to first dosing of study agent

Required values for initial laboratory tests:

Neutrophil count ≥ 1.0 x 10⁹/L
Platelet count ≥ 80 x 10⁹/L
Hemoglobin ≥ 10.0 g/dL
Serum creatinine ≤ 2.0 x mg/dL
AST/ALT ≤ 2.0 x upper limit of institutional normal
Serum bilirubin ≤ 2.0 x upper limit of institutional normal
No active or chronic infection with HIV, Hepatitis B, or Hepatitis C
ECOG performance status of ≤ 2
Life expectancy of ≥ 6 months
Men and women, ≥ 18 years of age
Adequate venous access (for Leukapheresis and blood draws)

Exclusion Criteria:

Serious illnesses, e.g., serious infections requiring antibiotics
Previous bone marrow or stem cell transplant
Study subjects with known chronic infection with HIV, hepatitis B or C. Testing will be performed if a study subject exhibits clinical signs of infection or to confirm a history of infection
Study subjects with known autoimmune disease [e.g. SLE, RA] who have had significant symptoms within the past 3 years. Study subjects with vitiligo are not excluded
Metastatic disease to the central nervous system
Other malignancy within 3 years prior to entry into the study, except for treated early-stage melanoma or non-melanoma skin cancer, cervical carcinoma in situ, or incidental or localized prostate cancer treated with prostatectomy or radiation therapy, or stage I colon cancer. Patients with other completely resected malignancies in the prior three years and no evidence of disease will be evaluated on a case- by- case basis with eligibility determined based on discussion with the Principal Investigator.
Prior chemotherapy or tumor vaccine therapy or biological therapy for treatment of melanoma. Subjects who received chemotherapy for the management of other malignancies are potentially eligible if the subject has not received chemotherapy in prior 5 years, remained disease free, and following discussion with and agreement by the principal investigator.
Radiation therapy or major surgery within 4 weeks prior to first dose of study agent
Concomitant treatment with systemic corticosteroids greater than physiologic doses. Topical (but not at the proposed vaccination sites) or inhalational steroids are permitted
Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first dose of study agent
Pregnancy or lactation. Pregnancy is associated with considerable immune suppression and this additional parameter may interfere with the evaluation of dendritic cell induced immune responses in melanoma study subjects. Pregnancy test must be negative on all women of reproductive potential at baseline (within 7 days of entry into the study) and they must agree to use birth control measures while on the study.
Study subjects previously treated with one of the peptides used in this trial, melanoma protein vaccine, melanoma whole cell vaccines, or with Montanide are not eligible
Any underlying medical or psychiatric condition, which in the opinion of the investigator will make the administration of study agents hazardous or obscure the interpretation of AEs
Lack of availability of study subject for immunological and clinical follow up assessments
Children < 18 years of age
Allergy to shellfish