Lymphoma Clinical Trial
Official title:
A Muliticenter, Dose-Reandomized Evaluation Of Targretin Capsules Plus PUVA In Patients With Stage IB - IIA Cutaneous T-Cell Lymphoma
Verified date | October 2003 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Health Science Center | Aurora | Colorado |
United States | University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham | Alabama |
United States | Boston Medical Center | Boston | Massachusetts |
United States | Northwestern University Medical Center | Chicago | Illinois |
United States | Rush-Presbyterian-St. Luke's Medical Center | Chicago | Illinois |
United States | Ireland Cancer Center | Cleveland | Ohio |
United States | Simmons Cancer Center - Dallas | Dallas | Texas |
United States | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | StonyBrook Dermatology Associates, P.C. | East Setauket | New York |
United States | University of Texas - MD Anderson Cancer Center | Houston | Texas |
United States | Knoxville Dermatology Group, P.C. | Knoxville | Tennessee |
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
United States | Tulane University School of Medicine | New Orleans | Louisiana |
United States | St. Luke's-Roosevelt Hospital Center - Roosevelt Division | New York | New York |
United States | Stanford University Medical Center | Stanford | California |
United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Millennix |
United States,
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