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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 metastatic melanoma
• Progressive or recurrent disease after prior aldesleukin
• HLA-A*0201 positive disease
• Recovered from prior therapy
• No concurrent systemic steroid therapy
• Not pregnant or nursing; fertile patients must use effective contraception during and for up to 4 months after receiving the preparative regimen
• No medical condition that would preclude study participation
• No history of severe immediate hypersensitivity reaction to any of the agents used in this study
• No contraindications for high-dose aldesleukin administration

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Study Outline:

Leukapheresis and cell preparation:

• Patients undergo leukapheresis to obtain stem cells (for re-infusion after peripheral blood lymphocyte therapy) and peripheral blood mononuclear cells

Lymphodepleting preparative regimen:

• Patients receive cyclophosphamide IV over 1 hour on Days -6 and -5 and fludarabine phosphate IV over 15–30 minutes on Days -6 to -2
• Patients undergo total-body irradiation twice on Day -2 and once on Day -1

Gene-engineered autologous peripheral blood lymphocyte infusion:

• Patients receive anti-MART-1 and anti-gp100 cells IV over 20–30 minutes on Day 0
• Patients also receive filgrastim subcutaneously daily beginning on Day 0 or 1 and continuing until blood counts recover

High-dose aldesleukin:

• Patients receive high-dose aldesleukin IV over 15 minutes every 8 hours on Days 0–4 (maximum of 15 doses)

Peptide vaccination:

• Patients are randomized to one of two peptide vaccination arms
  

  Arm I

  • Patients receive gp100 peptide vaccine emulsified in incomplete Freund’s adjuvant subcutaneously on Days 0, 7, and 14
  
  

  Arm II

  • Patients receive MART-1 peptide vaccine emulsified in incomplete Freund’s adjuvant subcutaneously on Days 0, 7, and 14

Autologous stem cell infusion:

• Patients receive autologous CD34+ selected stem cells IV on Day 1
• Patients are evaluated 4–6 weeks after completion of aldesleukin treatment
• Blood samples are collected periodically
• After completion of study therapy, patients are followed periodically for up to 15 years

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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: 5/19/09