Safety Study of a Helper Peptide Vaccine Plus Adjuvant Combinations for the Treatment of Melanoma

Exclusion Criteria

• •Participants who have received the following medications or treatments at any time within 4 weeks of registration:
• •* Chemotherapy
• •* Interferon (e.g. Intron-A®)
• •* Radiation therapy (Stereotactic radiotherapy, such as gamma knife, can be used ≥ 1 week and ≤ 6 months prior to registration)
• •* Allergy desensitization injections
• •* High doses of systemic corticosteroids, with the following qualifications and exceptions:
• •* In patients with adrenal or pituitary insufficiency replacement steroid doses are allowed; however, daily doses of 10 mg or more of prednisone (or equivalent) per day administered parenterally or orally are not allowed in patients with normal adrenal and pituitary function.
• •* Inhaled steroids (e.g.: Advair®, Flovent®, Azmacort®) are permitted at low doses (less than 500 mcg fluticasone per day, or equivalent) (76,77).
• •* Topical, nasal, and intra-articular corticosteroids are acceptable.
• •* Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)
• •* Interleukins (e.g. Proleukin®)
• •* Any investigational medication
• •* Targeted therapies specific for mutated BRAF or for MEK
• •Participants who are currently receiving nitrosoureas or who have received this therapy within the preceding 6 weeks
• •Participants who are currently receiving a checkpoint molecule blockade therapy, or who have received this therapy within the preceding 12 weeks.
• •Participants with known or suspected allergies to any component of the vaccine.
• •Participants may not have been vaccinated previously with any of the synthetic peptides included in this protocol. Participants who have received vaccinations containing agents other than the synthetic peptides included in this protocol and have recurred during or after administration of the vaccine will be eligible to enroll 12 weeks following their last vaccination.
• •Pregnancy. Female participants of childbearing potential must have a negative pregnancy test (urinary or serum beta-HCG) obtained within 2 weeks prior to registration. Males and females must agree, in the consent form, to use effective birth control methods during the course of vaccination.
• •Female participants must not be breastfeeding
• •Participants in whom there is a medical contraindication or potential problem in complying with the requirements of the protocol in the opinion of the investigator.
• •Participants classified according to the New York Heart Association classification as having Class III or IV heart disease (Appendix 4).
• •Participants with uncontrolled diabetes, defined as having a HgbA1c ≥ 7.5%.
• •Participants must not have had prior autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement. Participants with an active autoimmune disorder requiring these therapies are also excluded. The following will not be exclusionary:
• •* The presence of laboratory evidence of autoimmune disease (e.g. positive ANA titer) without symptoms
• •* Clinical evidence of vitiligo
• •* Other forms of depigmenting illness
• •* Mild arthritis requiring NSAID medications
• •Participants who have another cancer diagnosis, except that the following diagnoses will be allowed:
• •* squamous cell cancer of the skin without known metastasis
• •* basal cell cancer of the skin without known metastasis
• •* carcinoma in situ of the breast (DCIS or LCIS)
• •* carcinoma in situ of the cervix
• •* any cancer without distant metastasis that has been treated successfully, without evidence of recurrence or metastasis for over 5 years
• •Participants with known addiction to alcohol or drugs who are actively taking those agents, or participants with recent (within 1 year) or ongoing illicit IV drug use.
• •Body weight \< 110 pounds (without clothes) at registration, due to the amount and frequency with which blood will be drawn.