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Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma
This study is ongoing, but not recruiting participants.
Sponsored by: Millennix
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00030589
  Purpose

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.


Condition Intervention Phase
Lymphoma
Drug: bexarotene
Drug: methoxsalen
Procedure: UV light therapy
Phase II

MedlinePlus related topics: Cancer Fungal Infections Lymphoma
Drug Information available for: Methoxsalen Bexarotene
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: A Muliticenter, Dose-Reandomized Evaluation Of Targretin Capsules Plus PUVA In Patients With Stage IB - IIA Cutaneous T-Cell Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2001
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030589

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

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Study ID Numbers: CDR0000069179, MILL-61896, LIGAND-MILL-61896, NU-IRB-837-002
Study First Received: February 14, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00030589  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I cutaneous T-cell non-Hodgkin lymphoma
stage II cutaneous T-cell non-Hodgkin lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
stage I mycosis fungoides/Sezary syndrome
stage II mycosis fungoides/Sezary syndrome
recurrent mycosis fungoides/Sezary syndrome

Study placed in the following topic categories:
Sezary syndrome
Immunoproliferative Disorders
Cutaneous T-cell lymphoma
Lymphoma, small cleaved-cell, diffuse
Sezary Syndrome
Mycosis Fungoides
Recurrence
Mycoses
Lymphatic Diseases
Methoxsalen
Bexarotene
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:
Anticarcinogenic Agents
Photosensitizing Agents
Neoplasms
Neoplasms by Histologic Type
Radiation-Sensitizing Agents
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Protective Agents
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009