A feasibility study of roquinimex (Linomide) and alpha interferon in patients with advanced malignant melanoma or renal carcinoma

Thirty-one patients with advanced renal carcinoma or malignant melanoma wer e treated in the first feasibility study of alpha-interferon (Roferon) and the new oral immunomodulating agent, Linomide. Linomide 5 mg or 10 mg p.o, daily was given for 2 weeks; alpha-interferon was then added at 3 MU s.c. t hree times weekly, escalating in each patient by 3 MU per week, if tolerabl e, up to 12 MJ. The combination was poorly tolerated with nausea, vomiting somnolence and myalgia commonly reported. Adverse events accounted for trea tment withdrawal in ten patients and contributed to withdrawal in four othe r patients. Treatment with Linomide alone in the first 2 weeks led to a sig nificant increase in white blood cells, neutrophils and platelets. When alp ha-interferon was added, the platelet count decreased significantly over th e following 6 weeks. Nineteen patients had white cell phenotype and functio n measured; After 2 weeks of 5 mg Linomide, a transient but significant dec rease in the absolute number of activated T-helper cells (CD4(+)DR(+)) was observed. No changes in natural killer (NK) cell number or activity were ob served. Twenty-two patients were evaluable for response. One with metastati c renal cell carcinoma had a complete response and six had stable disease. This study does not support the use of the combination because significant toxicity was seen without the anticipated immunological benefits.