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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:

• Metastatic cancer
• Tumor overexpresses p53 as assessed by immunohistochemistry
• Biopsy must be available to evaluate p53 expression
• HLA-A*0201 positive
• Progressive or recurrent disease after prior standard therapy for metastatic disease
• Patients with melanoma or renal cell cancer must have previously received aldesleukin
• Patients with other histologies, not including hematologic malignancies, must have previously received first-line and second-line or higher systemic standard therapy (or effective salvage chemotherapy regimens)
• Recovered from prior therapy
• ECOG 0–1
• Lab values within normal range
• Not pregnant or nursing; fertile patients must use effective contraception during and for 4 months after completion of study treatment
• Patients who have previously received ipilimumab or ticilimumab must have a normal colonoscopy with normal colonic biopsies
• No contraindications for high-dose aldesleukin administration
• No major medical illness of the cardiovascular, respiratory, or immune system

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Treatment Plan:

Patients are stratified according to type of metastatic cancer (melanoma or renal cell cancer vs all other cancers).

Peripheral blood mononuclear cell (PBMC) collection:

• Patients undergo PBMC collection via leukapheresis for the generation of the adenovirus p53 dendritic cell vaccine as well as anti-p53 T-cell receptor (TCR) gene-engineered peripheral blood lymphocytes

Nonmyeloablative lymphocyte-depleting preparative regimen:

• Patients receive cyclophosphamide IV over 1 hour on Days -7 and -6 and fludarabine phosphate IV over 30 minutes on Days -5 to -1

Peripheral blood lymphocyte infusion:

• Patients receive anti-p53 TCR gene-engineered peripheral blood lymphocytes IV over 20–30 minutes on Day 0
• Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily beginning on Day 1 or 2 and continuing until blood counts recover

High-dose aldesleukin:

• Patients receive high-dose aldesleukin IV over 15 minutes, 3 times daily on Days 0–4 for up to 15 doses

Dendritic cell vaccine:

• Patients receive adenovirus p53 dendritic cell vaccine SC on Days 0, 7, 14, and 28

• Patients may receive one re-treatment course beginning 6–8 weeks after the last dose of high-dose aldesleukin
• After completion of study treatment, 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.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 12/5/08
Updated: 11/14/08