title: Phase II study of combined levamisole with recombinant interleukin-2 in patients with advanced malignant melanoma.
abstract: Adoptive immunotherapy (AI) with interleukin-2 (IL-2) and lymphokine-activated killer cells (LAK) is an antineoplastic modality in which immune-activated cells are administered to a host with advanced cancer in an attempt to mediate tumor regression. Levamisole (LEV), an immune stimulant, has been suggested to have therapeutic effectiveness in a variety of cancers. After a phase I trial of recombinant IL-2 plus LEV, a phase II trial of this combination was conducted in patients with advanced malignant melanoma. Nineteen patients were entered in the trial. They received IL-2 at 3 x 10(6) U/m2 subcutaneously daily x 5 plus LEV 50 mg/ m2 orally three times daily (p.o. t.i.d.) x 5. Patients were reevaluated at four-week intervals. None of the patients achieved a partial or complete regression (PR, CR). The median time to treatment failure (refusal, progression, or off study due to toxicity) was 56 days. Grade IV toxicities included vomiting (3 patients), lethargy (1 patient), and musculoskellar pain (1 patient). This regimen is not recommended for further testing in patients with advanced malignant melanoma.
authors.affiliation: Mayo Clinic, Rochester, MN 55905, USA.
authors.forename: E T
authors.initials: ET
authors.lastname: Creagan
authors.forename: K M
authors.initials: KM
authors.lastname: Rowland
authors.forename: V J
authors.initials: VJ
authors.lastname: Suman
authors.forename: C G
authors.initials: CG
authors.lastname: Kardinal
authors.forename: R F
authors.initials: RF
authors.lastname: Marschke
authors.forename: R S
authors.initials: RS
authors.lastname: Marks
authors.forename: W J
authors.initials: WJ
authors.lastname: Maples
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D016001:Confidence Intervals; D018450:Disease Progression; D005260:Female; D006801:Humans; D016219:Immunotherapy, Adoptive; D007279:Injections, Subcutaneous; D007376:Interleukin-2 / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015979:Killer Cells, Lymphokine-Activated / Q000276:immunology; D007978:Levamisole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008545:Melanoma / Q000628:therapy*; D008875:Middle Aged; D010146:Pain / Q000209:etiology; D011994:Recombinant Proteins; D012074:Remission Induction; D012894:Sleep Stages / Q000276:immunology; D015996:Survival Rate; D016896:Treatment Outcome; D016312:Treatment Refusal; D014839:Vomiting / Q000209:etiology
chemical_list: D000276:Adjuvants, Immunologic; D007376:Interleukin-2; D011994:Recombinant Proteins; D007978:Levamisole