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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 melanoma, meeting both of the following criteria:
  • Metastatic disease
  • Refractory to standard treatment (including high-dose aldesleukin)
• Measurable disease
• HLA-A*0201 positive
• Autologous cells unsuitable for IRB approved Surgery Branch adoptive cell therapy studies
• No positive allo-specific reactivity of the DMF5 cells to the patient’s peripheral blood mononuclear cells
• No symptomatic CNS lesions (may be eligible after treatment of symptomatic lesions)
• Recovered from prior therapy
• ECOG performance status 0–1
• ANC > 1,000/mm³ (without filgrastim [G-CSF] support)
• Hemoglobin > 8.0 g/dL
• Platelet count >100,000/mm³
• ALT and AST < 3 x upper limit of normal (ULN)
• Total bilirubin ≤ 2.0 mg/dL (≤ 3.0 mg/dL in patients with Gilbert’s syndrome)
• Creatinine ≤ 1.6 mg/dL
• HIV negative; hepatitis B antigen negative; hepatitis C antibody or antigen negative
• Not pregnant or nursing; fertile patients must use effective contraception during and for 4 months after receiving the preparative regimen
• No active systemic or opportunistic infections
• No coagulation disorders
• LVEF ≥ 45% by ECHO or MUGA scan (required for patients ≥ 60 years OR who have a cardiac abnormality)
• FEV1 ≥ 60% of predicted (for patients with a prolonged history of cigarette smoking [i.e., more than 20 pack years] or symptoms of respiratory dysfunction)
• No other major medical illness of the cardiovascular, respiratory, or immune system
• No history of severe immediate hypersensitivity reaction to any of the agents used in this study
• No allergy to penicillin

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Treatment Plan:

This is a phase I dose escalation study of allogeneic DMF5 cells followed by an open label phase II study.

Phase I:

Nonmyeloablative lymphocyte-depleting preparative regimen
• Patients receive cyclophosphamide IV over 1 hour on days -7 and -6 and fludarabine IV over 30 minutes on days -5 to -1

Allogeneic tumor-reactive lymphocyte (DMF5 cells) infusion
• Patients receive allogeneic DMF5 cells IV over 20-30 minutes on day 0
• Patients receive filgrastim (G-CSF) subcutaneously once daily beginning after the DMF5 cell infusion and continuing until blood counts recover

Consolidation therapy
• Beginning within 24 hours after the DMF5 cell infusion, patients receive high-dose aldesleukin IV over 15 minutes 3 times daily on days 0-4 (maximum of 15 doses)

Phase II:

• Patients receive treatment as in phase I
• Allogeneic DMF5 cells are administered at the maximum tolerated dose (MTD) determined in phase I

• After completion of study treatment, patients are followed at 4-6 weeks, once a month for 3 months, and then every 6 months for 2 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.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 12/5/08
Updated: 10/30/07