Phase II trial of a single weekly intravenous dose of ranpirnase in patients with unresectable malignant mesothelioma

Stanislaw M. Mikulski, John J. Costanzi, Nicholas J. Vogelzang, Spence McCachren, Robert N. Taub, Hoo Chun, Abraham Mittelman, Timothy Panella, Carmelo Puccio, Robert Fine, Kuslima Shogen

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Abstract

Purpose: A multicenter phase II trial of ranpirnase (Onconase; Alfacell Corp, Bloomfield, NJ) as a single agent was conducted to further assess the safety and clinical efficacy of this novel antitumor ribonuclease. Patients with unresectable and histologically confirmed malignant mesothelioma (MM) were eligible. Patients and Methods: One hundred five patients with Eastern Cooperative Oncology Group performance status 0 to 2 were enrolled onto the study. Thirty-seven percent of patients had not responded to prior chemotherapy. The primary end point of the study was survival. Tumor responses and time to progression were also assessed. The Cancer and Leukemia Group B (CALGB) prognostic group criteria were used to define a treatment target group (TTG). Both the intent-to-treat (ITT) and the TTG populations were analyzed for survival. Results: Median survival times of 6 months for the ITT and 8.3 months for the TTG populations were observed. The 1- and 2-year survival rates were 34.3% and 21.6% for ITT, respectively, and 42% and 26.8% for TTG, respectively. Among the 81 patients assessable for tumor response, four had partial responses, two had minor regressions, and thirty-five experienced stabilization of previously progressive disease. Patients with responses and stable disease demonstrated markedly prolonged survival. Ranpirnase was well tolerated in the majority of patients, and there were no drug-related deaths. Conclusion: Ranpirnase demonstrated activity and a tolerable toxicity profile in patients with unresectable MM. The prognostic value of the CALGB groups was confirmed.

Original languageEnglish (US)
Pages (from-to)274-281
Number of pages8
JournalJournal of Clinical Oncology
Volume20
Issue number1
DOIs
StatePublished - Jan 1 2002

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Survival
Health Services Needs and Demand
Neoplasms
Leukemia
Malignant Mesothelioma
ranpirnase
Therapeutics
Ribonucleases
Reaction Time
Survival Rate
Safety
Drug Therapy
Pharmaceutical Preparations

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Mikulski, S. M., Costanzi, J. J., Vogelzang, N. J., McCachren, S., Taub, R. N., Chun, H., ... Shogen, K. (2002). Phase II trial of a single weekly intravenous dose of ranpirnase in patients with unresectable malignant mesothelioma. Journal of Clinical Oncology, 20(1), 274-281. https://doi.org/10.1200/JCO.20.1.274

Phase II trial of a single weekly intravenous dose of ranpirnase in patients with unresectable malignant mesothelioma. / Mikulski, Stanislaw M.; Costanzi, John J.; Vogelzang, Nicholas J.; McCachren, Spence; Taub, Robert N.; Chun, Hoo; Mittelman, Abraham; Panella, Timothy; Puccio, Carmelo; Fine, Robert; Shogen, Kuslima.

In: Journal of Clinical Oncology, Vol. 20, No. 1, 01.01.2002, p. 274-281.

Research output: Contribution to journalArticle

Mikulski, SM, Costanzi, JJ, Vogelzang, NJ, McCachren, S, Taub, RN, Chun, H, Mittelman, A, Panella, T, Puccio, C, Fine, R & Shogen, K 2002, 'Phase II trial of a single weekly intravenous dose of ranpirnase in patients with unresectable malignant mesothelioma', Journal of Clinical Oncology, vol. 20, no. 1, pp. 274-281. https://doi.org/10.1200/JCO.20.1.274
Mikulski, Stanislaw M. ; Costanzi, John J. ; Vogelzang, Nicholas J. ; McCachren, Spence ; Taub, Robert N. ; Chun, Hoo ; Mittelman, Abraham ; Panella, Timothy ; Puccio, Carmelo ; Fine, Robert ; Shogen, Kuslima. / Phase II trial of a single weekly intravenous dose of ranpirnase in patients with unresectable malignant mesothelioma. In: Journal of Clinical Oncology. 2002 ; Vol. 20, No. 1. pp. 274-281.
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AU - Mikulski, Stanislaw M.

AU - Costanzi, John J.

AU - Vogelzang, Nicholas J.

AU - McCachren, Spence

AU - Taub, Robert N.

AU - Chun, Hoo

AU - Mittelman, Abraham

AU - Panella, Timothy

AU - Puccio, Carmelo

AU - Fine, Robert

AU - Shogen, Kuslima

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N2 - Purpose: A multicenter phase II trial of ranpirnase (Onconase; Alfacell Corp, Bloomfield, NJ) as a single agent was conducted to further assess the safety and clinical efficacy of this novel antitumor ribonuclease. Patients with unresectable and histologically confirmed malignant mesothelioma (MM) were eligible. Patients and Methods: One hundred five patients with Eastern Cooperative Oncology Group performance status 0 to 2 were enrolled onto the study. Thirty-seven percent of patients had not responded to prior chemotherapy. The primary end point of the study was survival. Tumor responses and time to progression were also assessed. The Cancer and Leukemia Group B (CALGB) prognostic group criteria were used to define a treatment target group (TTG). Both the intent-to-treat (ITT) and the TTG populations were analyzed for survival. Results: Median survival times of 6 months for the ITT and 8.3 months for the TTG populations were observed. The 1- and 2-year survival rates were 34.3% and 21.6% for ITT, respectively, and 42% and 26.8% for TTG, respectively. Among the 81 patients assessable for tumor response, four had partial responses, two had minor regressions, and thirty-five experienced stabilization of previously progressive disease. Patients with responses and stable disease demonstrated markedly prolonged survival. Ranpirnase was well tolerated in the majority of patients, and there were no drug-related deaths. Conclusion: Ranpirnase demonstrated activity and a tolerable toxicity profile in patients with unresectable MM. The prognostic value of the CALGB groups was confirmed.

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