Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma

December 17, 2013 updated by: Millennix

A Muliticenter, Dose-Reandomized Evaluation Of Targretin Capsules Plus PUVA In Patients With Stage IB - IIA Cutaneous T-Cell Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill cancer cells. Photosensitizing drugs, such as methoxsalen, are absorbed by cancer cells and, when exposed to light, become active and kill the cancer cells. Combining chemotherapy with photodynamic therapy may be an effective treatment for cutaneous T-cell lymphoma.

PURPOSE: Randomized phase II trial to study the effectiveness of combining different doses of bexarotene with photodynamic therapy in treating patients who have stage IB or stage IIA cutaneous T-cell lymphoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the efficacy of 2 different doses of bexarotene administered with ultraviolet A light therapy with methoxsalen (PUVA) in patients with stage IB or IIA cutaneous T-cell lymphoma.
  • Compare the safety of these regimens in these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive a lower dose of oral bexarotene once daily on weeks 1-26. Patients also receive ultraviolet A light therapy with oral methoxsalen 3 times weekly on weeks 2-26.
  • Arm II: Patients receive a higher dose of oral bexarotene once daily on weeks 1-26. Patients also receive ultraviolet A light therapy as in arm I.

Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • University of Alabama at Birmingham Comprehensive Cancer Center
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80010-0510
        • University of Colorado Health Science Center
    • Florida
      • Tampa, Florida, United States, 33612-9497
        • H. Lee Moffitt Cancer Center and Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush-Presbyterian-St. Luke's Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern University Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • Tulane University School of Medicine
      • Slidell, Louisiana, United States, 70459-0059
    • Massachusetts
      • Boston, Massachusetts, United States, 02118-2393
        • Boston Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, United States, 48201-1379
        • Barbara Ann Karmanos Cancer Institute
    • New York
      • East Setauket, New York, United States, 11733
        • StonyBrook Dermatology Associates, P.C.
      • New York, New York, United States, 10019
        • St. Luke's-Roosevelt Hospital Center - Roosevelt Division
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Knoxville Dermatology Group, P.C.
    • Texas
      • Dallas, Texas, United States, 75235-9154
        • Simmons Cancer Center - Dallas
      • Houston, Texas, United States, 77030-4009
        • University of Texas - MD Anderson Cancer Center
      • Tyler, Texas, United States, 75703

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed cutaneous T-cell lymphoma within the past year

  • Stage IB or IIA disease

    • No prior diagnosis more advanced than stage IIA disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Hemoglobin at least 9 g/dL
  • WBC at least 2,000/mm^3
  • Absolute lymphocyte count normal

Hepatic:

  • Bilirubin less than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 2.5 times ULN
  • No significant hepatic dysfunction

Renal:

  • Creatinine no greater than 2 times ULN
  • Calcium no greater than 11.5 mg/dL
  • No significant renal dysfunction

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for at least 1 month after study participation
  • Fasting triglycerides normal (fenofibrate or another anti-lipemic agent allowed except gemfibrozil)
  • HIV negative
  • No other concurrent known serious medical illness or infection that would preclude study participation
  • No prior uncontrolled hyperlipidemia
  • No pancreatitis or clinically significant risk factors for developing pancreatitis
  • No known allergy or sensitivity to retinoid class drugs or fenofibrate or idiosyncratic reactions to psoralen compounds
  • No history of light-sensitive disease states (e.g., lupus, porphyria, or albinism) or aphakia
  • No prior or concurrent melanoma or invasive squamous cell carcinoma
  • No pre-existing gallbladder disease

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior systemic anticancer interferon
  • No prior systemic anticancer denileukin diftitox

Chemotherapy:

  • At least 30 days since prior topical anticancer carmustine or mechlorethamine
  • No prior systemic anticancer alkaloid chemotherapy
  • No other concurrent systemic or topical anticancer chemotherapy (e.g., methotrexate or cyclophosphamide)

Endocrine therapy:

  • At least 30 days since prior topical anticancer corticosteroids
  • No concurrent systemic or topical anticancer corticosteroids

Radiotherapy:

  • No concurrent localized radiotherapy to specific study lesions except at investigator's discretion

Surgery:

  • Not specified

Other:

  • No prior systemic anticancer therapy
  • At least 30 days since prior topical anticancer therapy (e.g., ultraviolet B light or psoralen-ultraviolet-light therapy)
  • At least 30 days since prior participation in another investigational drug study
  • At least 30 days since prior vitamin A (at doses of more than 15,000 IU/day) or other retinoid class drugs
  • No other concurrent systemic or topical anticancer drugs or therapies
  • No other concurrent systemic retinoid class drugs, beta-carotene compounds, or vitamin A (at doses of more than 15,000 IU/day)
  • No other concurrent investigational medication
  • No concurrent gemfibrozil
  • No concurrent statin class anti-lipemics combined with fibrate class anti-lipemics (e.g., atorvastatin with fenofibrate)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Millennix

Investigators

  • Study Chair: Joan Guitart, MD, Robert H. Lurie Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Study Registration Dates

First Submitted

February 14, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

December 18, 2013

Last Update Submitted That Met QC Criteria

December 17, 2013

Last Verified

October 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069179
  • MILL-61896
  • LIGAND-MILL-61896
  • NU-IRB-837-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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