NCT00984464

Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma

A Phase 2 Study of Intravenous Administration of REOLYSIN (Reovirus Type 3 Dearing) in Combination With Paclitaxel and Carboplatin in Patients With Metastatic Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Oncolytics Biotech · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Phase 2 study is to investigate whether intravenous administration of REOLYSIN therapeutic virus in combination with paclitaxel and carboplatin is effective and safe in the treatment of metastatic melanoma.

Detailed description

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 predicted. 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 metastatic melanoma. 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.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	REOLYSIN	3x10E10 TCID50, 1 hour intravenous infusion, administered on Days 1,2,3,4 and 5 of a 21-day cycle
DRUG	Carboplatin	6 AUC mg/ml min, 30-min intravenous infusion, given on Day 1 of a 21-day cycle
DRUG	Paclitaxel	200 mg/m2, 3-hour intravenous infusion, given on Day 1 of a 21-day cycle

Timeline

• Start date: 2009-09-01
• Primary completion: 2014-02-01
• Completion: 2014-10-01
• First posted: 2009-09-25
• Last updated: 2015-04-10

Locations

1 site across 1 country: United States