Methyl-CCNU in Malignant Melanoma – A Divided Dose Schedule of Administration

Re, Wittes; Wk, Hong; Gatchell, L; Ih, Krakoff; Rb, Golbey

doi:10.1159/000225178

Oncology

1977

DOI: 10.1159/000225178

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Methyl-CCNU in Malignant Melanoma – A Divided Dose Schedule of Administration

Wittes Re¹,

Hong Wk²,

L Gatchell³

et al.

Abstract: Methyl-CCNU (NSC-95441) was administered to patients with malignant melanoma in a split dose schedule. Nausea and vomiting were eliminated as clinical problems during therapy. Response rate to the drug seemed somewhat lower than the average of three previously reported disease-oriented phase II trials, though the difference was not significant statistically. The time course of myelosuppression seemed comparable to that seen with a single dose schedule of administration.

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“…In a review by Comis and Carter, overall response rates of 13% for CCNU and 18% for BCNU and methyl CCNU have been reported [1]. In 441 patients treated with various nitrosoureas alone or in combination with agents other than DTIC, a response rate of 24% has been achieved in 15 series [8,9,37,[39][40][41][42][43][44][45][46][47][48][49][50]. In these reports, response rates range from 6% [37] to 41% [48] for series consisting of more than 15 patients.…”

mentioning

confidence: 99%

Chemotherapy of malignant melanoma

Benjamin

1979

World j. surg.

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A number of drugs are being used in chemotherapy treatment programs of advanced melanoma. Of these, DTIC is the most important drug currently in use, producing a response rate of about 20% when used as a single agent. Studies with nitrosoureas report response rates ranging from 6 to 41%, with an average of 24%. Combinations of these 2 agents and other drugs have not yet shown a significant improvement in response over either drug used alone. However, several studies of chemo-immunotherapy have reported overall response rates in the vicinity of 28%, somewhat higher than that obtained with chemotherapy alone.

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mentioning

confidence: 99%

Chemotherapy of malignant melanoma

Benjamin

1979

World j. surg.

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A randomized study of two different schedules of methyl CCNU, 5-FU and vincristine for metastatic colorectal carcinoma

Kemeny

Yagoda

Braun

et al. 1979

Cancer

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Sixty-seven patients with measurable colorectal carcinoma were randomized to receive two different schedules of Methyl CCNU, 5-FU and Vincristine (MOF). The treatment schedule consisted of Methyl CCNU 150 mg/m2 po q 70 days, 5-FU 300 mg/m2 iv for 5 consecutive days q 35 days, and Vincristine 1 mg/m2 IV q 35 days. The same total dose was used in each arm; in MOF A, the Methyl CCNU was given on day 1, while in MOF B, the Methyl CCNU was divided and given over 5 consecutive days. In MOF A, there was a 10% partial response rate and a 10% minor response rate. In MOF B, the partial response rate was 12% and the minor response rate was 21%. This difference is not statistically significant, but the patients in MOF B experienced less gastrointestinal toxicity (p less than .001).

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A Phase I trial of weekly lomustine in patients with advanced cancer

Koller

Benjamin

et al. 1994

Cancer

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Background. Lomustine is a commercially available chloroethyl nitrosourea compound whose antitumor activity in vitro and in animal tumor models exceeds its activity in humans. Part of the poor clinical performance of this drug may be explained by dose‐limiting subjective toxicity observed with the standard schedule of one oral dose of approximately 130 mg/m2 every 6–8 weeks. Methods. Twenty patients were enrolled in a Phase I clinical trial of weekly oral lomustine. The first dose level was 24 mg/m2, with subsequent dose increases in increments of 6 mg/m2. Intrapatient dose escalations were allowed if there were no toxic reactions noted after 12 weekly doses. Results. The dose‐limiting toxic effect was the development of thrombocytopenia in 35% of patients (6 of 17) treated at 30 mg/m2 after a median of 12 weekly doses (range, 5–20 weeks), whereas in 18% of patients (3 of 17), neutropenia developed after a median of 12 weeks (range, 9–22 weeks). Grade 3 or Grade 4 hematologic toxicity developed in three of three patients whose doses were escalated to 36 mg/m2/week after showing no evidence of toxicity for 12–16 weeks at 30 mg/m2/week. Partial remission was observed in two patients with malignant melanoma, and stable disease was observed in two patients with hypernephroma. Nausea, vomiting, and malaise were not significant complications of treatment. Conclusion. Lomustine can be administered at a dose of 30 mg/m2/week for 12+ weeks to patients with cancer who have received previous treatment with minimal toxicity while retaining antitumor activity.

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Methyl-CCNU in Malignant Melanoma – A Divided Dose Schedule of Administration

Cited by 3 publications

References 2 publications

Chemotherapy of malignant melanoma

Chemotherapy of malignant melanoma

A randomized study of two different schedules of methyl CCNU, 5-FU and vincristine for metastatic colorectal carcinoma

A Phase I trial of weekly lomustine in patients with advanced cancer

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