Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: Cellular Adoptive Immunotherapy in Treating Patients With Stage III or Stage IV Ovarian Cancer or Primary Peritoneal Cancer

Summary: RATIONALE: Biological therapies, such as cellular adoptive immunotherapy, stimulate the immune system in different ways and stop tumor cells from growing.
  PURPOSE: This phase I trial is studying the side effects and best dose of cellular adoptive immunotherapy in treating patients with stage III or stage IV ovarian cancer or primary peritoneal cancer.

Detailed description: OBJECTIVES:
  Primary
  -  Determine the safety and toxicity of autologous CD4-positive antigen-specific T cells in patients with stage III or IV ovarian epithelial cancer or primary peritoneal cavity cancer.
  -  Determine the duration of in vivo persistence of this drug in these patients.
  Secondary
  -  Determine the antitumor effect of this drug in these patients.
  OUTLINE: This is a dose-escalation study.
  Patients undergo leukapheresis for collection of T cells. Responder T cells are stimulated in vitro with autologous peripheral blood mononuclear cell-derived dendritic cells pulsed with NY-ESO-1 immunogenic peptides. Patients receive autologous CD4-positive antigen-specific T cells IV over 30 minutes.
  Cohorts of 3-6 patients receive escalating doses of autologous CD4-positive antigen-specific T cells until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
  Patients are followed at 4, 8, and 12 weeks and then periodically thereafter for survival.
  PROJECTED ACCRUAL: A total of 9-18 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed stage III or IV ovarian epithelial cancer or primary peritoneal cavity cancer meeting 1 of the following criteria:
  -  Progressive* or persistent* disease during or after primary chemotherapy
  -  Recurrent disease < 6 months after completion of primary therapy that had resulted in a complete response
  -  Persistent* or recurrent disease after second-line or additional therapies NOTE: *Progression or persistence can be based on serological (CA 125 > 100 U/mL OR 2 times baseline), radiographic (measurable or evaluable disease), or second-look surgical findings
  -  Tumor expressing NY-ESO-1 determined by IHC or RT-PCR
  -  HLA type expressing DPB*0401, DPB1*0201, DRB1*07
  -  No CNS metastases
  PATIENT CHARACTERISTICS:
  Age
  -  18 to 75
  Performance status
  -  Karnofsky 70-100%
  Life expectancy
  -  More than 16 weeks
  Hematopoietic
  -  Not specified
  Hepatic
  -  Not specified
  Renal
  -  Creatinine ≤ 2.0 mg/dL
  Cardiovascular
  -  No congestive heart failure*
  -  No clinically significant hypotension*
  -  No symptoms of coronary artery disease*
  -  No cardiac arrhythmias on EKG requiring drug therapy*
  -  No history of cardiovascular disease*
  -  No other significant cardiovascular abnormalities* NOTE: *Patients with any of the above undergo a stress test and/or echocardiography before being determined ineligible for study participation
  Pulmonary
  -  FEV_1 ≥ 60% of predicted*
  -  DLCO ≥ 55%* NOTE: *Patients with clinically significant pulmonary dysfunction only
  Other
  -  Not pregnant or nursing
  -  Fertile patients must use effective contraception
  -  HIV negative
  -  No active infection
  -  No oral temperature > 38.2°C within the past 72 hours
  -  No systemic infection requiring chronic maintenance or suppressive therapy
  PRIOR CONCURRENT THERAPY:
  Biologic therapy
  -  No other concurrent immunotherapy (e.g., interleukins, interferons, vaccines, intravenous immunoglobulin, or expanded polyclonal tumor-infiltrating lymphocytes or lymphokine-activated killer cell therapy)
  Chemotherapy
  -  See Disease Characteristics
  -  At least 3 weeks since prior standard or experimental chemotherapy
  Endocrine therapy
  -  No concurrent systemic corticosteroids except for treatment-related toxicity
  Radiotherapy
  -  At least 3 weeks since prior radiotherapy
  Surgery
  -  See Disease Characteristics
  Other
  -  At least 3 weeks since prior immunosuppressive therapy
  -  More than 3 weeks since prior investigational drugs and recovered
  -  No other concurrent investigational agents
  -  No concurrent pentoxifylline

Relevance to patient case: not relevant