FUSA With Intratumoral PolyICLC in Regionally Advanced Resectable Melanoma

Exclusion Criteria

• •9. Ability and willingness to give informed consent.
• •1. Any of the following medications or treatments are administered to the subject within 4 weeks of study day 1:
• •1. Radiation therapy (Note: Stereotactic radiotherapy, such as gamma knife, can be used ≥ 1 week prior to registration)
• •2. Allergy desensitization injections
• •3. High doses of systemic corticosteroids, with the following qualifications and exceptions:
• •* Daily doses of 10 mg or less prednisone (or equivalent) per day administered parenterally or orally are allowed in patients with normal adrenal and pituitary function.
• •* In patients with adrenal or pituitary insufficiency replacement steroid doses are allowed.
• •* Inhaled steroids (e.g.: Advair®, Flovent®, Azmacort®) are permitted at low doses (less than 500 mcg fluticasone per day, or equivalent) 41,42
• •* Topical and nasal corticosteroids are acceptable.
• •4. Growth factors (e.g. Procrit®, Aranesp®, Neulasta®)
• •5. Interleukins (e.g. Proleukin®)
• •6. Any investigational therapeutic agent.
• •7. Targeted therapies specific for mutated BRAF or for MEK
• •8. Live vaccine
• •9. Interferon (e.g. Intron-A®)
• •10. Cytotoxic chemotherapy for cancer
• •2. Subject has a known addiction to alcohol or drugs and is actively taking those agents, or has recently (within 1 year) taken these agents or has ongoing illicit IV drug use.
• •3. Subject is known to be HIV positive or has evidence of active Hepatitis B or C virus, unless:
• •* The subject has HIV but has been taking antiretroviral therapy, and agrees to take antiretroviral therapy throughout the study
• •* The subject has active Hepatitis B or C but does not have a detectable viral load
• •4. Pregnancy or breastfeeding. 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 treatment and following treatment in accordance with the labeling guidelines for each approved therapy.
• •5. Medical contraindications or potential problems that prevent compliance with the requirements of the protocol in the opinion of the investigator.
• •6. Active infection requiring systemic therapy.
• •7. The presence of Class III or IV heart disease as classified according to the New York Heart Association.
• •8. Previous treatment with polyICLC within 4 weeks. If a subject was previously treated with intratumoral polyICLC and experienced a significant (grade ≥3) toxicity related to the polyICLC treatment, the tumor that was treated should not be re-treated as part of this protocol.