MedTrace Logo

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

NCT00984464 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2015-04-10

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Devalingam Mahalingam, MD, PhD · Cancer Therapy & Research Center at UTHSCSA

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2014-02-28
Completion
2014-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00984464 on ClinicalTrials.gov