Clinical Trial for Melanoma: 06-C-0069: 1.888.NCI.1937

Evaluation of the Impact of Adjuvants Accompanying Peptide Immunization in High Risk Melanoma

Protocol # 06-C-0069

Why is this trial important?
Who is eligible for this trial?
What types of drugs or therapies are being used?
What is the study outline?
What is the frequency and duration of the visits?
What are the costs?
Who is the Principal Investigator?
Where is this trial taking place?
Who are the contacts for this trial?
Where can additional information be found?

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.

Who is eligible for this trial? (PDQ)

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

What types of drugs or therapies are being used?

Peptides, which are used to elicit an immune response against cancer, and agents, which may enhance this immune response.

What is the study outline? (PDQ)

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

What is the frequency and duration of the visits?

Leukapheresis will be utilized to obtain peripheral blood lymphocytes in all patients prior to treatment and approximately 3 weeks after the 4th, 8th, and 12th cycles of immunization in patients receiving peptide; pheresis will consist of a 7.5 to 10 liter exchange lasting approximately 3 hours
Immunizations will be administered on an outpatient basis unless side effects or the patient's clinical condition warrants hospitalization
Patients will receive full clinical evaluation three weeks after 8 cycles and 12 cycles
Once the treatment courses on this study are completed, patients will be seen in clinic every 6 months for 1 year and then annually for a minimum of 5 years or until evidence of tumor progression

What are the costs?

There is no charge for medical care received at the National Institutes of Health (NIH) Clinical Center. Patients will be responsible for travel costs for their initial screening visits. In most cases, once patients are enrolled in a trial, the National Cancer Institute (NCI) will pay the transportation costs for all subsequent trial-related visits for patients who do not live in the local area. In addition, these patients will receive a small per diem to help offset the costs of meals and lodging if they are being treated as outpatients.

It will be important to maintain your current insurance plan to cover all medical care that is provided away from the NIH Clinical Center.

No U.S. citizen or permanent U.S. resident residing in the U.S. who otherwise meets the eligibility requirements will be denied enrollment in clinical research protocols because of their inability to pay the costs of travel and subsistence.

Who is the Principal Investigator?

Dr. Steven A. Rosenberg is Chief of Surgery at the National Cancer Institute in Bethesda, Md., and a Professor of Surgery at the Uniformed Services University of Health Sciences and at the George Washington University School of Medicine and Health Sciences in Washington, D.C.

Dr. Rosenberg received his B.A. and M.D. degrees from The Johns Hopkins University in Baltimore, Md., and his Ph.D. in Biophysics from Harvard University. After completing his residency training in surgery in 1974 at the Peter Bent Brigham Hospital in Boston, Mass., Dr. Rosenberg became Chief of Surgery at the National Cancer Institute, a position he has held to the present time.

Where is this trial taking place?

NIH Clinical Center
National Institutes of Health
NCI, Surgery Branch, Tumor Immunology Section
10 Center Drive
Bethesda, Maryland 20892

Who are the contacts for this trial?

Steven A. Rosenberg, M.D., Ph.D.
Principal Investigator
Phone: 1-866-820-4505 (Toll Free)
ncisbirc@mail.nih.gov

Referrals:

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