Phase II trial of cisplatin and α-interferon in advanced malignant melanoma

Kim A. Margolin, James H. Doroshow, Steven A. Akman, Lucille A. Leong, Robert J. Morgan, George Somlo, James Raschko, Cynthia Pereira, Lisa Yonemoto, Chul Ahn

Research output: Contribution to journalArticle

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Abstract

Purpose: To evaluate the antitumor activity of combination cisplatin (CDDP) and α-interferon (α-IFN) in advanced, measurable metastatic melanoma. Patients and Methods: Adult patients with metastatic melanoma were required to have bidimensionally measurable lesions and a Karnofsky performance status ≥ 60%. Serum creatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 60 mL/min, adequate organ and bone marrow function, and radiologic proof of the absence of brain metastases were required. CDDP 40 mg/m2 intravenously (IV) on day 1 and day 8, and α-IFN 3 million units/m2 subcutaneously on days 1 to 5 and 8 to 12 were administered every 3 to 4 weeks. Results: Forty-two patients were entered onto this phase II trial and were assessable for response and toxicity. Three patients achieved complete responses (CRs) that lasted 31+, 5, and 8+ months. Seven patients had partial responses (PRs) and a median response duration of 4.4 months. The overall objective response rate was 24% (95% confidence interval, 12% to 39%). Toxicities were mild. Only 11 % of the courses required dose reduction of α-IFN, and three of 128 courses required CDDP dose reduction for reversible nephrotoxicity. Conclusion: The combination of moderate-dose CDDP and α-IFN as administered in this schedule is well tolerated and possesses encouraging activity in metastatic melanoma.

Original languageEnglish (US)
Pages (from-to)1574-1578
Number of pages5
JournalJournal of Clinical Oncology
Volume10
Issue number10
StatePublished - 1992

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Interferons
Cisplatin
Melanoma
Creatinine
Karnofsky Performance Status
Appointments and Schedules
Bone Marrow
Confidence Intervals
Neoplasm Metastasis
Brain
Serum

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Margolin, K. A., Doroshow, J. H., Akman, S. A., Leong, L. A., Morgan, R. J., Somlo, G., ... Ahn, C. (1992). Phase II trial of cisplatin and α-interferon in advanced malignant melanoma. Journal of Clinical Oncology, 10(10), 1574-1578.

Phase II trial of cisplatin and α-interferon in advanced malignant melanoma. / Margolin, Kim A.; Doroshow, James H.; Akman, Steven A.; Leong, Lucille A.; Morgan, Robert J.; Somlo, George; Raschko, James; Pereira, Cynthia; Yonemoto, Lisa; Ahn, Chul.

In: Journal of Clinical Oncology, Vol. 10, No. 10, 1992, p. 1574-1578.

Research output: Contribution to journalArticle

Margolin, KA, Doroshow, JH, Akman, SA, Leong, LA, Morgan, RJ, Somlo, G, Raschko, J, Pereira, C, Yonemoto, L & Ahn, C 1992, 'Phase II trial of cisplatin and α-interferon in advanced malignant melanoma', Journal of Clinical Oncology, vol. 10, no. 10, pp. 1574-1578.
Margolin KA, Doroshow JH, Akman SA, Leong LA, Morgan RJ, Somlo G et al. Phase II trial of cisplatin and α-interferon in advanced malignant melanoma. Journal of Clinical Oncology. 1992;10(10):1574-1578.
Margolin, Kim A. ; Doroshow, James H. ; Akman, Steven A. ; Leong, Lucille A. ; Morgan, Robert J. ; Somlo, George ; Raschko, James ; Pereira, Cynthia ; Yonemoto, Lisa ; Ahn, Chul. / Phase II trial of cisplatin and α-interferon in advanced malignant melanoma. In: Journal of Clinical Oncology. 1992 ; Vol. 10, No. 10. pp. 1574-1578.
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T1 - Phase II trial of cisplatin and α-interferon in advanced malignant melanoma

AU - Margolin, Kim A.

AU - Doroshow, James H.

AU - Akman, Steven A.

AU - Leong, Lucille A.

AU - Morgan, Robert J.

AU - Somlo, George

AU - Raschko, James

AU - Pereira, Cynthia

AU - Yonemoto, Lisa

AU - Ahn, Chul

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N2 - Purpose: To evaluate the antitumor activity of combination cisplatin (CDDP) and α-interferon (α-IFN) in advanced, measurable metastatic melanoma. Patients and Methods: Adult patients with metastatic melanoma were required to have bidimensionally measurable lesions and a Karnofsky performance status ≥ 60%. Serum creatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 60 mL/min, adequate organ and bone marrow function, and radiologic proof of the absence of brain metastases were required. CDDP 40 mg/m2 intravenously (IV) on day 1 and day 8, and α-IFN 3 million units/m2 subcutaneously on days 1 to 5 and 8 to 12 were administered every 3 to 4 weeks. Results: Forty-two patients were entered onto this phase II trial and were assessable for response and toxicity. Three patients achieved complete responses (CRs) that lasted 31+, 5, and 8+ months. Seven patients had partial responses (PRs) and a median response duration of 4.4 months. The overall objective response rate was 24% (95% confidence interval, 12% to 39%). Toxicities were mild. Only 11 % of the courses required dose reduction of α-IFN, and three of 128 courses required CDDP dose reduction for reversible nephrotoxicity. Conclusion: The combination of moderate-dose CDDP and α-IFN as administered in this schedule is well tolerated and possesses encouraging activity in metastatic melanoma.

AB - Purpose: To evaluate the antitumor activity of combination cisplatin (CDDP) and α-interferon (α-IFN) in advanced, measurable metastatic melanoma. Patients and Methods: Adult patients with metastatic melanoma were required to have bidimensionally measurable lesions and a Karnofsky performance status ≥ 60%. Serum creatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 60 mL/min, adequate organ and bone marrow function, and radiologic proof of the absence of brain metastases were required. CDDP 40 mg/m2 intravenously (IV) on day 1 and day 8, and α-IFN 3 million units/m2 subcutaneously on days 1 to 5 and 8 to 12 were administered every 3 to 4 weeks. Results: Forty-two patients were entered onto this phase II trial and were assessable for response and toxicity. Three patients achieved complete responses (CRs) that lasted 31+, 5, and 8+ months. Seven patients had partial responses (PRs) and a median response duration of 4.4 months. The overall objective response rate was 24% (95% confidence interval, 12% to 39%). Toxicities were mild. Only 11 % of the courses required dose reduction of α-IFN, and three of 128 courses required CDDP dose reduction for reversible nephrotoxicity. Conclusion: The combination of moderate-dose CDDP and α-IFN as administered in this schedule is well tolerated and possesses encouraging activity in metastatic melanoma.

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