you are not sure that pv10 would do better than a comparator arm of DTIC. Reeeeeally. This from the national cancer institute website.
from the website:
"Chemotherapy The objective response rate to DTIC and the nitrosoureas, carmustine (BCNU) and lomustine, is approximately 10% to 20%.[ 2, 31- 33] Responses are usually short-lived, ranging from 3 to 6 months, though long-term remissions can occur in a limited number of patients who attain a complete response.[ 31, 33] A randomized trial of DTIC versus temozolomide showed an OS of 6.4 months versus 7.7 months, respectively (HR = 1.18; 95% CI, 0.92–1.52). These data suggested similarity to DTIC; however, no benefit in survival has been demonstrated for either DTIC or temozolomide; therefore, temozolomide did not receive approval from the FDA.[ 3][ Level of evidence: 1iiA] Other agents with modest single-agent activity include vinca alkaloids, platinum compounds, and taxanes.[ 31, 32, 34]" |
