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Photopheresis as an Interventional Therapy for the Treatment of CTCL (Cutaneous T-Cell Lymphoma, Mycosis Fungoides) Stage 1A, 1B, 2A

NCT00221039 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2018-08-17

No results posted yet for this study

Summary

The study objective is to demonstrate that the UVADEX® Sterile Solution formulation of methoxsalen used in conjunction with the UVAR XTS Photopheresis System can have a clinical effect on the skin manifestations of CTCL (mycosis fungoides) in early stage disease.

Conditions

Interventions

DRUG

Methoxsalen+ECP

UVAdex+ECP will be administered: Treatment consists of two photopheresis treatments on successive days every 4 weeks for six months

Sponsors & Collaborators

  • Boston Medical Center

    collaborator OTHER

  • University of Pittsburgh

    collaborator OTHER

  • Case Western Reserve University

    collaborator OTHER

  • Vanderbilt University Medical Center

    collaborator OTHER

  • University of Minnesota

    collaborator OTHER

  • Rush University Medical Center

    collaborator OTHER

  • Mallinckrodt

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Madeleine Duvic, MD · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-02
Primary Completion
2011-04-05
Completion
2011-04-05

Countries

  • United States

Study Locations

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Entities

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 NCT00221039 on ClinicalTrials.gov