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Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma Clinical research trials and Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma. Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma clinical trial. Participants typically obtain the most effective healthcare available for their Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma  Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma
Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma
For Condition: recurrent mycosis fungoides/Sezary syndrome,recurrent cutaneous T-cell lymphoma,stage 1 cutaneous T-cell lymphoma,stage 2 mycosis fungoides/Sezary syndrome,stage 1 mycosis fungoides/Sezary syndrome,stage 2 cutaneous T-cell lymphoma
Status: No longer recruiting
Sponsor(s): Millennix ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JoanGuitart, Study Chair, Northwestern University Medical Center
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Tulane University School of Medicine
New Orleans, Louisiana, 70112
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Boston Medical Center
Boston, Massachusetts, 02118-2393
United States
University of Colorado Health Science Center
Aurora, Colorado, 80010-0510
United States
Northwestern University Medical Center
Chicago, Illinois, 60611
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
StonyBrook Dermatology Associates, P.C.
East Setauket, New York, 11733
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
Stanford University Medical Center
Stanford, California, 94305
United States
Knoxville Dermatology Group, P.C.
Knoxville, Tennessee, 37920
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
St. Luke's-Roosevelt Hospital Center - Roosevelt Division
New York City, New York, 10019
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
United States
Additional Information:
Study ID Numbers: CDR0000069179; NU-IRB-837-002,LIGAND-MILL-61896,MILL-61896
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030589
Other Stage 2 Cutaneous T-Cell Lymphoma Studies:
1. O(6)-benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma
2. Depsipeptide in Treating Patients With Solid Tumors
3. Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma
4. Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides
5. Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma
Related Studies:
Other stage 2 cutaneous T-cell lymphoma Clinical Trials
Other Michigan Clinical Trials
Other Detroit Clinical Trials
Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma
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