A Phase 2 Study of Intravenous Administration of REOLYSIN (Reovirus Type 3 Dearing) in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma
Cutaneous melanoma is one of the most rapidly increasing cancers in the US and around the
world with an increase in incidence of about 3-7% per year for fair-skinned Caucasian
populations. An estimated 62,480 cases of invasive melanoma will be diagnosed in the US in
2008 with an estimated 8,420 deaths. An additional 46,170 cases of melanoma in situ are
Melanoma that has spread to distant sites (stage IV) is rarely curable.
This Phase 2 study is designed to characterize the efficacy and safety of REOLYSIN given
intravenously in combination with paclitaxel and carboplatin every 3 weeks in patients with
Response is a primary endpoint of this trial.
Patients may continue to receive chemotherapy in combination with REOLYSIN for up to 8
cycles and may continue indefinitely on REOLYSIN monotherapy under this protocol, provided
they have not experienced either progressive disease or unacceptable drug-related toxicity
that does not respond to either supportive care or dose reduction.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the antitumor effect in terms of objective response rates (i.e., partial response (PR) and complete response (CR) to treatment)
must be confirmed 4 weeks after the criteria for response are first met.
Devalingam Mahalingam, MD, PhD
Cancer Therapy & Research Center at UTHSCSA
United States: Food and Drug Administration
|Cancer Therapy & Research Center at UTHSCSA||San Antonio, Texas 78229|