Active specific immunotherapy of metastatic melanoma with an antiidiotype vaccine: a phase I/II trial of I-Mel-2 plus SAF-m.

PURPOSE: To determine the toxicity and immunologic activity of an antiidiotype melanoma vaccine that consists of monoclonal antibody I-Mel-2 (MELIMMUNE-2, IDEC Pharmaceuticals, La Jolla, CA) and an immunologic adjuvant SAF-m. PATIENTS AND METHODS: Twenty-six patients with metastatic melanoma, 17 of whom had previously received chemotherapy, were given 2 mg of I-Mel-2 and either 100 micrograms (n = 6) or 250 micrograms (n = 20) of SAF-m. Antiidiotype vaccine was given intramuscularly (IM) biweekly for 4 weeks, and then bimonthly until disease progression. Human antimurine antibodies (HAMA), anti-I-Mel-2 antibodies, and specific antibody (Ab)3 against the melanoma epitope mimicked by the vaccine were titrated before treatment, biweekly from weeks 4 to 12, and every 4 to 8 weeks thereafter. Computed tomographic (CT) scans of the chest, abdomen, and pelvis and magnetic resonance imaging (MRI) of the brain were obtained before and bimonthly during treatment to evaluate responses. RESULTS: Elevated titers of human antimouse antibodies and anti-I-Mel-2 antibodies were associated with clinical antitumor effect (P = .02 and P = .05, respectively). Ab3 was absent in most patients, but was found in the best clinical responder. Fever, myalgias/arthralgias, fatigue, nausea, and headaches were the most common toxicities. Grade III myalgias/arthralgias and headaches required dose reduction of SAF-m in eight patients at the 250-microgram dose. No treatment-related death occurred. Six patients had an antitumor effect: one complete response in liver and lung, two minor responses, and three stable disease. The patient with a complete response has survived nearly 5 years. CONCLUSION: I-Mel-2 antiidiotype vaccine was safe, tolerated best at the 100-microgram dose of SAF-m, and had immunologic and clinical activity.

Fatigue in patients with cancer receiving interferon alpha.

Fatigue is the most frequently reported symptom of patients with cancer. The purpose of this study was to describe the experience of fatigue over time in patients with cancer receiving treatment with interferon alpha. Piper's Integrated Fatigue Model guided this study. A descriptive repeated-measures design was used. A convenience sample of 30 patients with malignant melanoma was drawn from a comprehensive cancer center in Southern California. Two instruments were used in data collection, the Symptom Distress Scale and the Piper Fatigue Scale. Study findings revealed descriptive data on patients' perceptions of the causes and remedies for fatigue while receiving active treatment for cancer. The pattern of fatigue was consistent over the five points of time during treatment, with the most extreme fatigue scores in the affective domain, followed by the sensory, temporal, total fatigue, and fatigue severity scores. The patterns and dimensions of fatigue provide implications for care of patients receiving interferon alpha, and for further investigation in the area of fatigue as a critical aspect of quality of life.