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

NCT00030589 | Unknown Phase 2

• 4 other identifiers: CDR0000069179MILL-61896LIGAND-MILL-61896NU-IRB-837-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 19

Brief Summary

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.

Conditions

Lymphoma

Keywords

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

Interventions

bexarotene DRUG

methoxsalen DRUG

UV light therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Millennix: lead

Study Sites (19)

University of Alabama at Birmingham Comprehensive Cancer Center

Birmingham, Alabama, 35294-3300, United States

Location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

University of Colorado Health Science Center

Aurora, Colorado, 80010-0510, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Northwestern University Medical Center

Chicago, Illinois, 60611, United States

Location

Rush-Presbyterian-St. Luke's Medical Center

Chicago, Illinois, 60612, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Unknown Facility

Slidell, Louisiana, 70459-0059, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118-2393, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

StonyBrook Dermatology Associates, P.C.

East Setauket, New York, 11733, United States

Location

St. Luke's-Roosevelt Hospital Center - Roosevelt Division

New York, New York, 10019, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Knoxville Dermatology Group, P.C.

Knoxville, Tennessee, 37920, United States

Location

Simmons Cancer Center - Dallas

Dallas, Texas, 75235-9154, United States

Location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Unknown Facility

Tyler, Texas, 75703, United States

Location

Related Publications (1)

• Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.

  PMID: 32632956 DERIVED

MeSH Terms

Conditions

Lymphoma; Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome

Interventions

Bexarotene; Methoxsalen; Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Furocoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Phototherapy; Therapeutics

Study Officials

• Joan Guitart, MD

  Robert H. Lurie Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 14, 2002
• First Posted: January 27, 2003
• Study Start: February 1, 2001
• Last Updated: December 18, 2013

Record last verified: 2003-10

Locations

US (19)