DTIC and combination therapy for melanoma. II. Escalating schedules of DTIC with BCNU, CCNU, and vincristine.
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Antineoplastic Agents↗
Biomedical subjects
G E Metter
Publications and source records attributed to G E Metter.
Phase II study of 5-azacytidine in solid tumors.
One hundred and seventy-seven patients were evaluated after therapy with 5-azacytidine using a dose of 1.6 mg/kg/day X 10 days followed by a maintenance regimen. One hundred and forty-eight of the patients received the drug by rapid iv infusion and 29 received the drug daily by and infusion that lasted between 18 and 24 hours. Hematologic toxicity was significant but transient in both groups. Nausea was severe using the rapid iv infusion and minimal with the slow infusion. Antitumor effect was seen in 17% of the evaluable patients with carcinoma of the breast and 21% of the patients with malignant lymphomas. Occasional responses were seen with a variety of other solid tumors. The responses were transient, and clinically, resistance to 5-azacytidine appeared to develop quite rapidly. No clear-cut difference was seen in response rates or duration of response between the two groups of patients. Cross resistance to other anticancer agents was not noted. It is believed that the drug is only of minimal value as a single agent in solid tumors using either of the methods of administration described.
Adolescent↗
Phase I and preliminary phase II observations of high-dose intermittent 6-thioguanine.
6-Thioguanine was administered iv or orally to 66 patients on an intermittent schedule, one dose every 3 weeks. Doses were gradually escalated until moderate toxicity was observed. The dose-limiting toxic effects were myelosuppression and azotemia. The recommended starting doses for phase II or III studies were 700 mg/m2 iv and 1400 mg/m2 orally. Nephrotoxicity and myelosuppression were reversible in all clearly drug-related instances. Myelosuppression was transient, with nadir blood cell counts observed 10-14 days after drug administration. No cumulative toxicity was observed. Antitumor responses were observed in five of 21 evaluable patients with metastatic colorectal carcinoma including two of four previously untreated patients with that disease. Other than a transient response in a patient with endometrial carcinoma, who received her drug orally, all other responses were observed in patients treated iv with 6-thioguanine. Further phase II trials, particularly in colorectal carcinoma, are recommended.
Dose-Response Relationship, Drug↗