A phase III comparison of methyl-CCNU + vincristine with or without BCG + allogeneic tumor cells in metastatic melanoma |
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| Authors: | M. J. Mastrangelo R. E. Bellet D. Berd |
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| Affiliation: | (1) Melanoma Unit, The Fox Chase Cancer Center, 7701 Burholme Avenue, 19111 Philadelphia, PA, USA;(2) Department of Medicine, Temple University School of Medicine, 3401 N-Broad St., 19140 Philadelphia, PA, USA;(3) Department of Medicine, University of Pennsylvania School of Medicine, 34th an Spruce Streets, 19104 Philadelphia, PA, USA |
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| Abstract: | Summary Sixty-two patients with metastatic malignant melanoma were randomized to treatment with either (a) methyl-CCNU (200 mg/m2, PO every 8 weeks) plus vincristine (2 mg IV every 4 weeks), or (b) the same chemotherapy plus intradermal (ID) injections of irradiated (15,000 rads) allogeneic (fresh-frozen) melanoma cells (1–2×108) admixed with BCG (Glaxo, 2–4.5×106 organisms) every 2 weeks. Treatment cycles were repeated every 8 weeks until tumor progression. Seven (2 CR, 5 PR) objective remissions were noted among 31 patients (22.5%) treated with chemotherapy alone, whereas six (3 CR, 3 PR) objective remissions were noted among 31 patients (19%) treated with chemoimmunotherapy (P>0.05). The medians for remission duration (6 months) and survival (6.5 months) in the chemotherapy group did not differ significantly from the medians for remission duration (8 months) and survival (8 months) in the chemoimmunotherapy group. The patients manifested no unexpected toxicity. Hematologic toxicity was experienced by patients on both regimens; however, those receiving chemoimmunotherapy rebounded more quickly. |
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