BACKGROUND: The treatment of advanced renal cell cancer remains unsatisfactory, therefore new combination regimens such as thalidomide and IL-2 are of interest. A phase I trial of SC IL-2 and oral thalidomide was performed to identify the toxicity, maximum tolerated dose (MTD) and preliminary clinical activity of this regimen. METHODS: 33 patients with advanced/metastatic RCC were enrolled. An established 8-week outpatient schedule of subcutaneously administered IL-2 in escalating doses, days 1-5, for 6 weeks with a 2 week rest was utilized with daily oral thalidomide. Cohorts of 4-6 patients were treated at 4 dose levels. RESULTS: Toxicity was moderate to severe and related to dose level. All patients developed fever, chills and fatigue. 29/33 patients developed < or = Grade 2 desquamation of hands and feet and/or rash. Dose limiting toxicity (DLT) included Grade 3 neutropenia and pulmonary embolus. The maximum tolerated dose (MTD) of IL-2 and thalidomide was 9.0 MIU/m2 s.c. days 1-5, weeks 1 to 6 and 100 mg p.o. daily, respectively. A median of 2 cycles of therapy was administered (range 1-9). 2/33 patients responded (1 CR--prior IL-2 therapy, 1 PR--no prior therapy) with an overall response of 6% (95% CI, 1-20%). One minimal response was converted to a surgical CR (remains disease free at 24 + months). CONCLUSION: Outpatient administration of IL-2 and thalidomide is possible with acceptable toxicity. Further evaluation of this regimen is underway.
BACKGROUND: The treatment of advanced renal cell cancer remains unsatisfactory, therefore new combination regimens such as thalidomide and IL-2 are of interest. A phase I trial of SC IL-2 and oral thalidomide was performed to identify the toxicity, maximum tolerated dose (MTD) and preliminary clinical activity of this regimen. METHODS: 33 patients with advanced/metastatic RCC were enrolled. An established 8-week outpatient schedule of subcutaneously administered IL-2 in escalating doses, days 1-5, for 6 weeks with a 2 week rest was utilized with daily oral thalidomide. Cohorts of 4-6 patients were treated at 4 dose levels. RESULTS:Toxicity was moderate to severe and related to dose level. All patients developed fever, chills and fatigue. 29/33 patients developed < or = Grade 2 desquamation of hands and feet and/or rash. Dose limiting toxicity (DLT) included Grade 3 neutropenia and pulmonary embolus. The maximum tolerated dose (MTD) of IL-2 and thalidomide was 9.0 MIU/m2 s.c. days 1-5, weeks 1 to 6 and 100 mg p.o. daily, respectively. A median of 2 cycles of therapy was administered (range 1-9). 2/33 patients responded (1 CR--prior IL-2 therapy, 1 PR--no prior therapy) with an overall response of 6% (95% CI, 1-20%). One minimal response was converted to a surgical CR (remains disease free at 24 + months). CONCLUSION:Outpatient administration of IL-2 and thalidomide is possible with acceptable toxicity. Further evaluation of this regimen is underway.
Authors: Charles L Bennett; Glen T Schumock; Apurva A Desai; Hau C Kwaan; Dennis W Raisch; Rebecca Newlin; Walter Stadler Journal: Am J Med Date: 2002-11 Impact factor: 4.965
Authors: R M Bukowski; T Olencki; Q Wang; D Peereboom; G T Budd; P Elson; K Sandstrom; L Tuason; P Rayman; R Tubbs; D McLain; E Klein; A Novick; J Finke Journal: J Immunother Date: 1997-07 Impact factor: 4.456
Authors: W D Figg; W Dahut; P Duray; M Hamilton; A Tompkins; S M Steinberg; E Jones; A Premkumar; W M Linehan; M K Floeter; C C Chen; S Dixon; D R Kohler; E A Krüger; E Gubish; J M Pluda; E Reed Journal: Clin Cancer Res Date: 2001-07 Impact factor: 12.531
Authors: B Escudier; N Lassau; D Couanet; E Angevin; F Mesrati; S Leborgne; A Garofano; C Leboulaire; N Dupouy; A Laplanche Journal: Ann Oncol Date: 2002-07 Impact factor: 32.976
Authors: Danai D Daliani; Christos N Papandreou; Peter F Thall; Xuemei Wang; Cherie Perez; Rose Oliva; Lance Pagliaro; Robert Amato Journal: Cancer Date: 2002-08-15 Impact factor: 6.860
Authors: Apurva A Desai; Nicholas J Vogelzang; Brian I Rini; Rafat Ansari; Stuart Krauss; Walter M Stadler Journal: Cancer Date: 2002-10-15 Impact factor: 6.860
Authors: Howard A Fine; Patrick Y Wen; Elizabeth A Maher; Elene Viscosi; Tracy Batchelor; Nehal Lakhani; William D Figg; Benjamin W Purow; Craig B Borkowf Journal: J Clin Oncol Date: 2003-06-15 Impact factor: 44.544