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Investigator(s):
Steven A. Rosenberg, M.D., Ph.D. Principal Investigator Phone: 1-866-820-4505 (Toll Free) ncisbirc@mail.nih.gov
Referral Contact(s):
Linda Williams, R.N. Research Nurse Phone: 1-866-820-4505 (Toll Free) Fax: 301-451-1927 ncisbirc@mail.nih.gov	June A. Kryk, R.N. Research Nurse Phone: 1-866-820-4505 (Toll Free) Fax: 301-451-1927 ncisbirc@mail.nih.gov

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Primary Eligibility:

• Diagnosis of primary melanoma meeting any of the following criteria:
• Ulcerated lesions ≥ 2 mm
• Any lesion ≥ 4 mm in thickness
• At least one positive lymph node
• A recurrence of disease that has been completely excised
• Must be HLA A0201 positive
• Must be ≥ 16 years old, in good general health with histologically confirmed cutaneous melanoma; ocular or mucosal primary not eligible; must be clinically disease free at the time of protocol entry
• Must not have had previous treatment with gp100 vaccine or any chemotherapy; previous treatment with interferon or local radiation allowed
• Patients must be within 6 months of the surgery that made them disease free, with their disease-free status confirmed by CT of chest/abdomen/pelvis taken within 4 weeks of visit; must have a clear MRI of the brain
• No active systemic infection; no autoimmune disease; no immunodeficiency disease

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Study Outline:

All injections will be given on Day 1 every 3 weeks for a total of 12 cycles.

After completion of study treatment, patients are followed every 6 months for 1 year and then annually for 5 years.

Patients will be randomized into one of the following six arms:

Arm I (Closed to accrual as of 1/11/08)

• gp100:209-217(210M) peptide emulsified in Montanide^® ISA-51 or Montanide ISA-51 VG injected subcutaneously

Arm II (Closed to accrual as of 1/11/08)

• gp100:209-217(210M) peptide emulsified in Montanide ISA-51 or Montanide ISA-51 VG injected subcutaneously; following the injection patients will apply imiquimod cream 5% to the skin at the site of injection daily for 5 days

Arm III (Closed to accrual as of 1/11/08)

• gp100:209-217(210M) peptide in 0.9% sodium chloride injection, injected intradermally

Arm IV (Closed to accrual as of 1/11/08)

• gp100:209-217(210M) peptide in 0.9% sodium chloride injection, injected intradermally; following the injection patients will apply imiquimod cream 5% to the skin at the site of the injection daily for 5 days

Arm V

• gp100:209-217(210M) peptide emulsified in Montanide^® ISA 51 VG, using a three-way stopcock with two syringes, and then injected subcutaneously on Day 1 every three weeks (1 cycle) for a total of twelve cycles (33 weeks)

Arm VI

• gp100:209-217(210M) peptide emulsified via the two syringe method in Montanide^® ISA 51 VG injected subcutaneously on Day 1 every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection, patients will apply imiquimod to the skin at the site of injection daily for 5 days

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 6/29/09
Updated: 8/3/09