title: Phase II trial of interferon and thalidomide in metastatic renal cell carcinoma.
abstract: OBJECTIVE
  To evaluate the toxicity and efficacy of interferon and thalidomide combination in a phase II clinical trial.
  
  
  METHODS
  Eligibility included metastatic renal cancer with a maximum of two prior regimens, performance status of 0-2 and adequate renal, hepatic and bone marrow function.
  
  
  RESULTS
  Twenty patients were enrolled on this phase II trial. Median age was 60.5 years (Range: 39-75 years). 17 patients had visceral metastases (lung/liver/both) and 3 patients had lymph node only metastases. A total of 26 cycles of 4 weeks each were administered; median of 1 cycle and range from 0-9 cycles. The therapy was poorly tolerated with grade 3 adverse events noted in 12 (60%) of the 20 patients. No objective responses were noted. Of the 14 response evaluable patients, one had an unconfirmed response (38% decrease in size) and one had prolonged disease stabilization for 10 months. The median time to progression was 1.0 month and median survival was 2.8 months. Pre and post therapy PET scans were performed nine weeks apart on one patient. The mean standardized uptake values (SUV) declined from 1.45 (SUV min-max 0.89-1.76) to 1.12 (SUV min-max 0.55-1.47), denoting anti vascular effect. The patient did not have an objective response but had a disease stabilization sustained for 10 months.
  
  
  CONCLUSIONS
  The combination of interferon and thalidomide has minimal efficacy and considerable toxicity which makes this combination unworthy of future investigation in metastatic renal cancer.
authors.affiliation: Division of Oncology, Department of Medicine, Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA. vaishamu@karmanos.org
authors.forename: Ulka N
authors.initials: UN
authors.lastname: Vaishampayan
authors.forename: Lance K
authors.initials: LK
authors.lastname: Heilbrun
authors.forename: Anthony F
authors.initials: AF
authors.lastname: Shields
authors.forename: Jawana
authors.initials: J
authors.lastname: Lawhorn-Crews
authors.forename: Karen
authors.initials: K
authors.lastname: Baranowski
authors.forename: Daryn
authors.initials: D
authors.lastname: Smith
authors.forename: Lawrence E
authors.initials: LE
authors.lastname: Flaherty
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001247:Asthenia / Q000139:chemically induced; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D004334:Drug Administration Schedule; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D007372:Interferons / Q000008:administration & dosage / Q000009:adverse effects; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D049268:Positron-Emission Tomography / Q000379:methods; D013262:Stevens-Johnson Syndrome / Q000139:chemically induced; D013792:Thalidomide / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D013792:Thalidomide; D007372:Interferons