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
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.