Phase II trial of dolastatin-10, a novel anti-tubulin agent, in metastatic soft tissue sarcomas

Margaret Von Mehren, S. P. Balcerzak, A. S. Kraft, J. H. Edmonson, Scott Heitaka Okuno, M. Davey, S. McLaughlin, M. T. Beard, A. Rogatko

Research output: Contribution to journalArticle

30 Citations (Scopus)

Abstract

Patients: Soft tissue sarcomas are uncommon malignancies with few therapeutic options for recurrent or metastatic disease. Dolastatin-10 (Dol-10) is a pentapeptide anti-microtubule agent that binds to tubulin sites distinct from vinca alkaloids. Based on the novel mechanism of action, limited activity of other anti-microtubular agents, and anti-neoplastic activity in pre-clinical screening of Dol-10, this multi-institutional phase II study was conducted to determine the objective response rate of Dol-10 in recurrent or metastatic soft tissue sarcomas that had not been treated with chemotherapy outside of the adjuvant setting. Methods: Dol-10 was given intravenously at a dose of 400 μg/m2 and repeated every 21 days. Toxicities were assessed using the Common Toxicity Criteria (version 2.0). Radiographic studies and tumor measurements were repeated every two cycles to assess response [Miller AB, et al. Cancer 1981; 47(1): 207]. Results: Dol-10 was associated with hematological toxicity and with some vascular toxicities. There was no significant gastrointestinal, hepatic or renal toxicity. There was one death on study due to respiratory failure. There were no objective responses in 12 patients treated with Dol-10. Discussion: Based on this phase II trial, further study of Dol-10 on this schedule is not recommended in advanced or metastatic soft tissue sarcomas.

Original languageEnglish (US)
Pages (from-to)107-111
Number of pages5
JournalSarcoma
Volume8
Issue number4
DOIs
StatePublished - Dec 2004

Fingerprint

dolastatin 10
Tubulin
Sarcoma
Vinca Alkaloids
Neoplasms
Adjuvant Chemotherapy
Microtubules
Respiratory Insufficiency
Blood Vessels
Appointments and Schedules

Keywords

  • Anti-microtubule agent
  • Dolastatin-10
  • Soft tissue sarcoma

ASJC Scopus subject areas

  • Oncology

Cite this

Von Mehren, M., Balcerzak, S. P., Kraft, A. S., Edmonson, J. H., Okuno, S. H., Davey, M., ... Rogatko, A. (2004). Phase II trial of dolastatin-10, a novel anti-tubulin agent, in metastatic soft tissue sarcomas. Sarcoma, 8(4), 107-111. https://doi.org/10.1080/13577140400009163

Phase II trial of dolastatin-10, a novel anti-tubulin agent, in metastatic soft tissue sarcomas. / Von Mehren, Margaret; Balcerzak, S. P.; Kraft, A. S.; Edmonson, J. H.; Okuno, Scott Heitaka; Davey, M.; McLaughlin, S.; Beard, M. T.; Rogatko, A.

In: Sarcoma, Vol. 8, No. 4, 12.2004, p. 107-111.

Research output: Contribution to journalArticle

Von Mehren, M, Balcerzak, SP, Kraft, AS, Edmonson, JH, Okuno, SH, Davey, M, McLaughlin, S, Beard, MT & Rogatko, A 2004, 'Phase II trial of dolastatin-10, a novel anti-tubulin agent, in metastatic soft tissue sarcomas', Sarcoma, vol. 8, no. 4, pp. 107-111. https://doi.org/10.1080/13577140400009163
Von Mehren, Margaret ; Balcerzak, S. P. ; Kraft, A. S. ; Edmonson, J. H. ; Okuno, Scott Heitaka ; Davey, M. ; McLaughlin, S. ; Beard, M. T. ; Rogatko, A. / Phase II trial of dolastatin-10, a novel anti-tubulin agent, in metastatic soft tissue sarcomas. In: Sarcoma. 2004 ; Vol. 8, No. 4. pp. 107-111.
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