• Return to search results
• Start new search

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

---

Primary Eligibility:

• Histologically confirmed high-risk primary cutaneous melanoma meeting any of the following criteria:
• Ulcerated lesions ≥ 2 mm in thickness
• Any lesions ≥ 4 mm in thickness
• At least 1 positive lymph node
• Local recurrence
• Metastatic disease that was surgically resected within the past 6 months
• Clinically disease free as documented by radiologic studies within the past 6 weeks
• HLA-A*0201 positive
• No ocular or mucosal melanoma
• Recovered from prior therapy (vitiligo or alopecia allowed)
• No prior immunization with MART-1
• ≥ 3 weeks since prior systemic therapy, including adjuvant immunotherapy, (e.g., interferon) for melanoma
• Prior surgery within the past 3 weeks allowed for melanoma
• No concurrent systemic steroid therapy
• No autoimmune disease
• No known immunodeficiency disease (primary or secondary), as evidenced by abnormal WBC count
• No active systemic infections, including concurrent opportunistic infections
• No known severe hypersensitivity to any of the agents used in this study
• No concurrent major medical illnesses
• Not pregnant or nursing; fertile patients must use effective contraception during and for 4 months after completion of study therapy

---

Study Outline:

Patients undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMC) PBMCs are then cultured in the presence of anti-CD3 (OKT3) and aldesleukin to stimulate T-cell growth. The T cells are transduced with the anti-MART-1 F5 T-cell receptor (TCR) retroviral vector and then expanded in vitro. Patients are then randomized to 1 of 4 treatment arms.

• Arm I:
  
  
  • Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes IV over 20–30 minutes on Day 0
  
  
  
• Arm II:
  
  
  • Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes as in arm I and MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 subcutaneously (SC) on Days 0 and 30
  
  
  
• Arm III:
  
  
  • Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes as in arm I and aldesleukin SC on Days 0–4
  
  
  
• Arm IV:
  
  
  • Patients receive anti-MART-1 F5 TCR-transduced peripheral blood lymphocytes as in arm I, MART-1:26-35(27L) peptide vaccine emulsified in Montanide ISA-51 as in arm II, and aldesleukin as in arm III
  
  
  

• Patients undergo blood sample collection periodically
• After completion of study therapy, patients are followed periodically for up to 15 years

---

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.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 6/29/09
Updated: 5/14/09