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MRX, Radiation, and Chemotherapy for Patients With Resected Squamous Cell Carcinoma of the Head and Neck

NCT00427102 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2012-11-14

No results posted yet for this study

Summary

Rationale for Study

Oral mucositis is a major complication arising from contemporary chemoradiation treatment of patients with head and neck cancer.

No effective therapy exists to prevent this complication in this population. MRX-1024 is an investigational agent that has demonstrated in in vitro and in vivo experiments to have the potential to exert a protective effect in normal mucosa cells, without interfering with the intended antitumor effect of radiation.

A pilot Phase 1 study of MRX-1024 was conducted in India in patients with head and neck cancer receiving radiation alone or radiation in combination with cisplatin or carboplatin. MRX 1024 doses of 100 mgkg given orally twice a day, five days a week during radiation treatment cycles, were well tolerated and appeared to exert a protective effect against the development of severe mucositis.

Twice daily doses of MRX 1024 impose a certain level of inconvenience to the patient, to their clinic companion, and to the general work flow within radiation oncology clinics.

This study is designed to study the safety and pharmacokinetics of both single daily dose and twice daily dose regimens of oral MRX 1024 given in conjunction with daily radiation fractions and intermittent high-dose cisplatin to patients with high-risk for recurrence head and neck cancer following surgical resection. The study will also document the incidence and severity of oral mucositis that occurs following such therapy. The results will be instrumental in determining the regimen of MRX 1024 to use in subsequent definitive clinical trials.

Conditions

Interventions

DRUG

Oral MRX-1024

PROCEDURE

Standard Fractionation Radiation Therapy

DRUG

High-Dose Cisplatin Chemotherapy

Sponsors & Collaborators

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Gopal Bajaj, M.D. · Johns Hopkins University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Completion
2007-07-31

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Diseases

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 NCT00427102 on ClinicalTrials.gov