NCT00221039

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_4

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2004

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2011

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

7 years

First QC Date

September 13, 2005

Last Update Submit

August 15, 2018

Conditions

Cutaneous T Cell LymphomaMycosis Fungoides

Keywords

ECPPhotopheresisCTCLCutaneous T Cell LymphomaMycosis Fungoides

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint will be the overall response based on skin-weighted assessment.

    The overall skin repsonse will be assessed at 6month and will consist of an experts assessment of the % of skin involvement at baseline and 6 months.

    6 months

Secondary Outcomes (1)

  • Quality of life assessed by questionnaire

    6 months

Study Arms (1)

DRUG+ECP

EXPERIMENTAL

UVVADEX +ECP will be administered to patients with CTCL.Duration of Treatment: The study will consist of 2 treatment periods, a 6-month initial period and a 6-month follow-up period where photopheresis therapy may continue.

Drug: Methoxsalen+ECP

Interventions

Methoxsalen+ECPDRUG

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

Also known as: Uvadex
DRUG+ECP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients are to be greater than 40 kg body weight.
  • Patients must have adequate veins to provide intravenous access.
  • Women who are not pregnant, lactating, or of childbearing potential. Lack of childbearing potential was defined as:
  • Being post-menopausal
  • Being surgically sterile
  • Practicing contraception
  • Patients with childbearing potential had to have a negative serum human chorionic gonadotropin (HCG) upon entrance into the study.
  • Patients must be willing to adhere to the protocol, and sign an Informed Patient Consent Form prior to entry into the study.
  • Patients must not be on any other investigational device/drug treatment.
  • Patients with the diagnosis of mycosis fungoides (MF) including a skin biopsy consistent with MF (atypical epidermotrophic or folliculocentric T-cells).
  • Appropriate staging as IA, IB or IIA : T1 or T2 (patches or plaques) with measurable lesions.
  • IA patients must show evidence of a minor blood abnormality by morphology or laboratory assessment.
  • For IIA patients - clinically significant nodes (1.5 cm) must have lymph node biopsy showing dermatopathic nodes or no involvement.
  • Patients must be willing and able to discontinue concomitant medications for MF.
  • Patients currently taking the following drugs must discontinue medication prior to enrollment in the trial:
  • +7 more criteria

You may not qualify if:

  • Patients who have MF (T3 cutaneous tumors or T4 exfoliative erythroderma) Stage IIB - IVB, ie. no pathological node or visceral involvement.
  • Patients who are unable to tolerate extracorporeal volume loss (e.g., severe cardiac disease or severe anemia or weight \< 40 kg).
  • Patients with recent (within three months) deterioration of renal function who have a serum creatinine level greater than 3.0 mg/dL.
  • Patients with lipemic plasma \> 500 ng/dL or uncontrolled diabetes.
  • Patients with a history of liver damage (2.5 x normal ALT, AST) or porphyria.
  • Patients with positive tests for HIV antibody, hepatitis C virus (HCV) antibody or hepatitis B surface antigen.
  • Patients on oral prednisone therapy or full body or high potency topical steroids.
  • Women who are pregnant or nursing a child.
  • Patients with severe emotional, behavioral or psychiatric problems that, in the opinion of the investigator, would result in poor compliance with the treatment regimen.
  • Patients who exhibit idiosyncratic or hypersensitivity reactions to 8-methoxypsoralen compounds, heparin, or citrate.
  • Patients with previous exposure to photopheresis therapy.
  • Patients who use tanning beds or are receiving phototherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Rush-Presbyterian Hospital

Chicago, Illinois, 60612, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

University Hospital of Cleveland/Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Talpur R, Demierre MF, Geskin L, Baron E, Pugliese S, Eubank K, Zic JA, Miller DR, Tharp M, Bohjanen K, Duvic M. Multicenter photopheresis intervention trial in early-stage mycosis fungoides. Clin Lymphoma Myeloma Leuk. 2011 Apr;11(2):219-27. doi: 10.1016/j.clml.2011.03.003. Epub 2011 Apr 8.

    PMID: 21575927RESULT

MeSH Terms

Conditions

Lymphoma, T-Cell, CutaneousMycosis Fungoides

Interventions

Methoxsalen

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

FurocoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-Ring

Study Officials

  • Madeleine Duvic, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

April 2, 2004

Primary Completion

April 5, 2011

Study Completion

April 5, 2011

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

US(7)