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Phase 2 Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Head and Neck Carcinoma

NCT00753038 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2014-11-04

No results posted yet for this study

Summary

The purpose of this Phase 2 study is to investigate whether intravenous administration of REOLYSIN® therapeutic reovirus in combination with Paclitaxel and Carboplatin is effective and safe in the treatment of squamous cell carcinoma of the head and neck.

Conditions

  • Carcinoma, Squamous Cell of the Head and Neck

Interventions

BIOLOGICAL

REOLYSIN®

3E10 TCID50, 1 hour intravenous infusion, administered on Days 1, 2, 3, 4 and 5 of a 21 day cycle

DRUG

Carboplatin

5 AUC mg/mL min, 30 min intravenous infusion, given on Day 1 of a 21 day cycle

DRUG

Paclitaxel

175 mg/m2, 3 hour intravenous infusion, given on Day 1 of a 21 day cycle

Sponsors & Collaborators

Principal Investigators

  • Monica Mita, MD · Cancer Therapy and Research Center, Texas

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2011-07-31
Completion
2013-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT00753038 on ClinicalTrials.gov