gene-modified lymphocytes, high-dose aldesleukin, and vaccine therapy in treating patients with progressive or recurrent metastatic cancer

Conditions: Kidney Cancer; Melanoma (Skin); Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: gene-modified lymphocytes may stimulate the immune system in different ways and stop tumor cells from growing. high-dose aldesleukin may stimulate lymphocytes to kill tumor cells. vaccines made from a gene modified virus and a person's dendritic cells may help the body build an effective immune response to kill tumor cells. giving gene-modified lymphocytes together with high-dose aldesleukin and vaccine therapy may kill more tumor cells. purpose: this phase ii trial is studying how well giving gene-modified lymphocytes together with high-dose aldesleukin and vaccine therapy works in treating patients with progressive or recurrent metastatic cancer.

objectives: primary * determine if the administration of anti-p53 t-cell receptor (tcr) gene-engineered peripheral blood lymphocytes, high-dose aldesleukin, and adenovirus p53 dendritic cell (dc) vaccine after a nonmyeloablative, but lymphoid-depleting, preparative regimen will result in clinical tumor regression in patients with metastatic cancer that overexpresses p53. secondary * determine the in vivo survival of t-cell receptor (tcr) gene-engineered cells. * determine the ability of a dendritic cell (dc) vaccine to restimulate tcr gene-engineered cells in vivo. * determine the toxicity profile of this treatment regimen. outline: 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 intravenously (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 (growth colony stimulating factor (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 three 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 as above (nonmyeloablative preparative regimen, peripheral blood lymphocyte infusion, high-dose aldesleukin, and dendritic cell vaccinations) 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.

Eligibility criteria:
disease characteristics: * diagnosis of metastatic cancer * tumor overexpresses p53 as assessed by immunohistochemistry (i.e., ≥ 5% tumor cells stain positive for p53) * biopsy must be available to evaluate p53 expression * human leukocyte antigens 0201 (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) patient characteristics: * eastern cooperative oncology group (ecog) performance status 0 or 1 * life expectancy \> 3 months * absolute neutrophil count \> 1,000/mm\^3 * white blood cell (wbc) \> 3,000/mm\^3 * platelet count \> 100,000/mm\^3 * hemoglobin \> 8.0 g/dl * serum alanine aminotransferase (alt)/aspartate aminotransferase (ast) ≤ 2.5 times upper limit of normal * serum creatinine ≤ 1.6 mg/dl * total bilirubin ≤ 2.0 mg/dl (\< 3.0 mg/dl in patients with gilbert's syndrome) * not pregnant or nursing * negative pregnancy test * 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 * human immunodeficiency virus (hiv) antibody negative * hepatitis b antigen and hepatitis c antibody negative (unless antigen negative) * no primary immunodeficiency (e.g., severe combined immunodeficiency disease) * no active systemic infections * no history of severe immediate hypersensitivity reaction to any of the agents used in this study * no coagulation disorders * no myocardial infarction or cardiac arrhythmias * no history of coronary revascularization * no obstructive or restrictive pulmonary disease * no contraindications for high-dose aldesleukin administration * left ventricular ejection fraction (lvef) ≥ 45% in patients meeting any of the following criteria: * history of ischemic heart disease, * chest pain, * or clinically significant atrial and/or ventricular arrhythmias including, but not limited to, atrial fibrillation, * ventricular tachycardia, * or second- or third-degree heart block * at least 60 years of age * forced expiratory volume 1 (fev_1) \> 60% predicted in patients meeting any of the following criteria: * prolonged history of cigarette smoking (\> 20 pack/year within the past 2 years) * symptoms of respiratory dysfunction * no other major medical illness of the cardiovascular, * respiratory, * or immune system prior concurrent therapy: * see disease characteristics * recovered from prior therapy * more than 4 weeks since prior and no concurrent systemic steroid therapy * more than 4 weeks since other prior systemic therapy * more than 6 weeks since prior ipilimumab

Keywords: recurrent renal cell cancer stage iv renal cell cancer recurrent melanoma stage iv melanoma unspecified adult solid tumor, protocol specific