Ma. Rosenthal et R. Oratz, PHASE-II CLINICAL-TRIAL OF RECOMBINANT ALPHA-2B INTERFERON AND 13-CISRETINOIC ACID IN PATIENTS WITH METASTATIC MELANOMA, American journal of clinical oncology, 21(4), 1998, pp. 352-354
Treatment for metastatic melanoma is limited by low response rates to
single- or combination-agent chemotherapy. Recent studies have examine
d the role of biologic modifiers and differentiating agents. This phas
e II study examined the efficacy and toxicity of combining alpha-2b-in
terferon (IFN gamma) and 13 cis retinoic acid (cRA) in the treatment o
f metastatic malignant melanoma. Thirteen patients were treated with I
FN alpha (5 x 10(6) units/m(2) three times weekly) and cRA (1 mg/kg pe
r day). One patient with lung and adrenal metastases had a partial res
ponse 6 months in duration and two patients had stabilization of lung
metastases for 2 months. All other patients had progressive disease. T
oxicity was substantial with all patients experiencing Eastern Coopera
tive Oncology Group grade 1-2 fatigue, myalgias, anorexia, stomatitis,
and cheilitis. In addition, serum cholesterol and triglycerides were
elevated in all patients. Seven patients required 50% dose reductions
because of hypertriglyceridemia, fatigue associated with a significant
decline in performance status, and severe stomatitis with anorexia an
d weight loss. One patient discontinued therapy because of a decline i
n performance status. This study suggests this combination of cRA and
IFN alpha is inactive in the treatment of metastatic melanoma and is a
ssociated with substantial toxicity.