title: Phase II trial of pegylated interferon and thalidomide in malignant metastatic melanoma.
abstract: Pegylated interferon and thalidomide demonstrate immunomodulatory and antiangiogenic activity, and efficacy in melanoma. The combination was evaluated in a phase II trial. Eligibility included biopsy-confirmed malignant melanoma with metastases and progression, maximum of two earlier systemic therapies, performance status of 0-2, and adequate hepatic, bone marrow and renal function. Pegylated interferon was administered at a dose of 0.5 microg/kg subcutaneously weekly and thalidomide 200 mg orally daily. Toxicity was evaluated every 2 weeks and response every 8 weeks. Eighteen patients were enrolled in this trial. Median age was 55.5 years (range: 29-80 years). Seventeen patients had visceral metastases and one had lymph node-only metastases. Two patients had brain metastases. Nine patients had received earlier adjuvant therapy and 16 patients had received earlier therapy for metastatic disease. Performance status was 0, 1 and 2 in 11, six and one patients, respectively. Severe (grade 4) toxicities observed were anemia in two patients and thrombocytopenia in one patient. No treatment-related deaths occurred. Dose escalation of thalidomide to 300 mg daily was feasible in four patients. One therapy-related hospitalization for nausea and dehydration occurred. No objective responses were noted; three patients demonstrated disease stabilization. The regimen of pegylated interferon and thalidomide was well tolerated. The combination, however, failed to demonstrate clinical efficacy in pretreated metastatic malignant melanoma.
authors: Division of Oncology, Department of Medicine, Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, Michigan, USA. vaishamu@karmanos.org
authors: Ulka N
authors: UN
authors: Vaishampayan
authors: Lance K
authors: LK
authors: Heilbrun
authors: Cynthia
authors: C
authors: Marsack
authors: Daryn W
authors: DW
authors: Smith
authors: Lawrence E
authors: LE
authors: Flaherty
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000556:secondary; D008875:Middle Aged; D011092:Polyethylene Glycols; D011994:Recombinant Proteins; D013792:Thalidomide / Q000008:administration & dosage
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D011092:Polyethylene Glycols; D013792:Thalidomide; C417083:peginterferon alfa-2b