A randomised dose escalation study of subcutaneous interleukin 2 with and without levamisole in patients with metastatic renal cell carcinoma or malignant melanoma.

We have examined the efficacy, toxicity and host immunological response of two different dose schedules of interleukin 2 (IL-2) given subcutaneously, daily for 3 months in patients with renal cell carcinoma (RCC) or metastatic melanoma (MM). We also examined the effect of adding the immune modulator levamisole to the two different schedules of IL-2. Thirty-nine patients were entered into two sequential phase I/II studies.

The use of cisplatin plus 5-fluorouracil chemotherapy in an unselected group of patients with recurrent squamous cell carcinoma of the head and neck.

Cisplatin and infusional 5-fluorouracil (5-FU) has become regarded as the standard chemotherapy for squamous cell carcinoma (SCC) of the head and neck. Results of phase II studies vary widely and do not always reflect the activity of regimen in general clinical practice. We have treated 20 consecutive patients with cisplatin 100 mg/m2 and 5-FU given as a 4-day infusion at 1 g/m2 for 24 h.

A phase II study of the sequential administration of dacarbazine and fotemustine in the treatment of cerebral metastases from malignant melanoma.

34 patients with cerebral metastases from malignant melanoma received sequential dacarbazine at 250 mg/m2 followed 2 h later by fotemustine at 100 mg/m2; this was repeated on day 8. Maintenance therapy was given every 4 weeks to patients with radiological evidence of response or stable disease until a maximum response was achieved plus two more cycles. A 12% response rate was obtained for cerebral metastases, with 2 complete responses lasting 12 and 36+ months, and 2 partial responses lasting 2.

Immune changes in peripheral blood resulting from locally directed interleukin-2 therapy in squamous cell carcinoma of the head and neck.

Interleukin-2 (IL-2) was administered locally by constant intra-arterial infusion in four escalating doses from 3 x 10(4)-3 x 10(7) IU/day to 12 patients with squamous cell carcinoma of the head and neck (SCCHN) in a phase I trial. Lymphocyte phenotypic markers and serum cytokine concentrations were measured over the course of treatment. Serum IL-1-alpha, -beta and IL-6 were not induced at any dose level.