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Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma
This study is ongoing, but not recruiting participants.
Study NCT00030589   Information provided by National Cancer Institute (NCI)
First Received: February 14, 2002   Last Updated: February 6, 2009   History of Changes

February 14, 2002
February 6, 2009
February 2001
 
 
 
Complete list of historical versions of study NCT00030589 on ClinicalTrials.gov Archive Site
 
 
 
Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma
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.

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.

Phase II
Interventional
Treatment, Randomized, Open Label, Active Control
Lymphoma
  • Drug: bexarotene
  • Drug: methoxsalen
  • Procedure: UV light therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00030589
 
CDR0000069179, MILL-61896, LIGAND-MILL-61896, NU-IRB-837-002
Millennix
 
Study Chair: Joan Guitart, MD Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
October 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP