Melanoma – NCI-06-C-0069
Dr. Steven A. Rosenberg
Principal Investigator
NCI is currently conducting the following trial for patients with melanoma. Click on the trial below for additional details, including a summary of eligibility criteria, treatment plan, and information on how to contact Dr. Rosenberg and his staff directly.
You may also call the Clinical Trials Referral Office at 1-888-NCI-1937 (1-888-624-1937) to inquire about referring a patient to this trial.
All injections will be given on Day 1 every 3 weeks for a total of 12 cycles (33 weeks).
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
Why is this trial important?
In the past 10 years, much has been learned about the nature of the immune system response against cancer. Attempts are under way to develop tumor-specific vaccines based on specific proteins expressed on tumor cells. In previous clinical trials, we have successfully immunized high risk melanoma patients in the adjuvant setting with melanoma peptides. In this study, we further explore the optimal methods for immunizing this patient population using peptides in combination with additional agents that may enhance the immune response.
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