Journal of Clinical Oncology, Vol 5, 1078-1082, Copyright © 1987 by American Society of Clinical Oncology
Phase II studies of single-agent cimetidine and the combination N- phosphonacetyl-L-aspartate (NSC-224131) plus L-alanosine (NSC-153353) in advanced malignant melanoma
RF Morton, ET Creagan, SA Cullinan, JA Mailliard, L Ebbert, MH Veeder and M Chang
We conducted parallel phase II trials of cimetidine as a single agent and
the combination N-phosphonacetyl-L-aspartate (PALA) plus L- alanosine among
40 previously untreated patients with biopsy-proven, measurable
disseminated malignant melanoma. We did not design the trial to be a
comparative assessment of the two regimens. Among 19 patients treated with
cimetidine, 300 mg orally four times daily, there was one complete response
of extensive pleural and pulmonary metastases for 16+ months and two
partial regressions of soft tissue lesions for 7 and 21+ months,
respectively. Among 21 patients treated with the combination regimen, there
was only one partial response in soft tissue for 1 month. The median times
to progression and death were 1.4 and 6 months, respectively, for
cimetidine, and 1.3 and 4 months, respectively, from the combination of
PALA plus L-alanosine. Among patients who progressed on initial treatment,
there were no responses in 12 who received crossover therapy with
cimetidine and 11 with the combination regimen. Two patients treated with
the combination program had severe stomatitis, two developed renal failure,
and one had severe leukopenia and thrombocytopenia. Recognizing the
limitations of small sample size, these early observations suggest that
cimetidine may have intriguing implications in the management of
disseminated malignant melanoma.
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