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Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides Clinical research trials and Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides. Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides clinical trial. Participants oftentimes recieve the finest healthcare available for their Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "U" Clinical Trials Conditions > Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides  Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides
Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides
For Condition: stage 2 mycosis fungoides/Sezary syndrome,recurrent mycosis fungoides/Sezary syndrome,stage 1 mycosis fungoides/Sezary syndrome
Status: Recruiting
Sponsor(s): EORTC Cutaneous Lymphoma Task Force ,
Synopsis: RATIONALE: Ultraviolet light therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known whether ultraviolet light therapy is more effective with or without bexarotene in treating mycosis fungoides. PURPOSE: Randomizedphase III trial to compare the effectiveness of ultraviolet light therapy using methoxsalen with or without bexarotene in treating patients who have mycosis fungoides.
Details: OBJECTIVES: - Compare the cumulative dose of ultraviolet A light required to achieve a complete clinical response (CCR) in patients with mycosis fungoides treated with ultraviolet A light therapy with methoxsalen (PUVA) with or without bexarotene. - Compare the overall response rate (CCR and partial response) in patients treated with these regimens. - Compare the duration of CCR and time to relapse of patients treated with these regimens. - Compare the number of PUVA sessions necessary to achieve a CCR in these patients. - Determine the percentage of dropouts by patients treated with these regimens. - Determine the safety of these regimens in these patients. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, age (60 and under vs over 60), and stage of disease (IB vs IIA). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive PUVA comprising oral methoxsalen given 2 hours before whole body ultraviolet A therapy. PUVA is given 3 times per week. - Arm II: Patients receive oral bexarotene once daily and PUVA as in arm I. In both arms, treatment repeats for up to 16 weeks in the absence of complete clinical response, disease progression, or unacceptable toxicity. Patients are followed every 8 weeks until the first documented progression or relapse. PROJECTED ACCRUAL: A total of 134 patients (67 per treatment arm) will be accrued for this study within 17 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed mycosis fungoides - Stage IB or IIA - Confirmed by current or prior diagnostic lesion biopsy PATIENT CHARACTERISTICS: Age - Over 18 Performance status - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - WBC at least 2,000/mm^3 - Hemoglobin at least 9 g/dL Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST and ALT no greater than 2.5 times ULN Renal - Creatinine no greater than 2 times ULN - Calcium no greater than 11.5 mg/dL Cardiovascular - No New York Heart Association grade III or IV cardiac insufficiency Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for at least 3 months after study participation* NOTE: *Women using hormonal contraception must also use a non-hormonal treatment - Fasting triglycerides normal (prior antilipemic agents allowed to reach normalization) - Willing and able to avoid prolonged exposure to the sun - Willing to limit sun exposure on day of PUVA therapy - No prior intolerance of or unresponsiveness to PUVA therapy - No other prior or concurrent malignant tumor except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer - No prior pancreatitis - No other concurrent serious illness or infection that would preclude study participation - No concurrent excessive alcohol consumption - No photosensitivity due to intrinsic (e.g., lupus) or extrinsic (e.g., photosensitive drugs) factors - No psychological, familial, sociological, or geographical condition that would preclude study compliance - No known contraindications to study drug - No known hypersensitivity to retinoids or hypervitaminosis A - No uncontrolled diabetes mellitus - No uncontrolled thyroid disease PRIOR CONCURRENT THERAPY: Biologic therapy - At least 3 months since prior interferon therapy Chemotherapy - No prior systemic combination chemotherapy - No prior participation in another study of bexarotene - At least 3 months since prior topical chemotherapy Endocrine therapy - At least 1 month since prior topical corticosteroids Radiotherapy - At least 6 months since prior total skin electron beam therapy - At least 1 month since prior superficial radiotherapy Surgery - Not specified Other - At least 30 days since prior participation in another investigational drug study - At least 3 months since prior photopheresis - At least 1 month since prior UVB/PUVA phototherapy - At least 1 month since prior retinoid class drugs - At least 1 month since prior beta-carotene compounds - At least 1 month since other prior topical medications (e.g., tar baths) - No prior participation in this study - No other concurrent anticancer therapy - No other concurrent investigational drug therapy - No concurrent drugs associated with pancreatic toxicity or known to increase triglyceride concentrations
Total Enrollment:
Location and Contact Information:
Overall Study Official:
SeanWhittaker, , Guy's and St. Thomas' Hospitals NHS Trust
Guy's and St. Thomas' Hospitals NHS Trust *Recruiting*
London, England, SE1 9RT
United Kingdom
Recruiting Contact Person 44-20-792-892-92 ext. 1333
Additional Information:
Study ID Numbers: CDR0000271933; EORTC-21011
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056056
Other Recurrent Mycosis Fungoides/sezary Syndrome Studies:
1. Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma
2. Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides
3. Depsipeptide in Treating Patients With Solid Tumors
4. O(6)-benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma
5. Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides
Related Studies:
Other recurrent mycosis fungoides/Sezary syndrome Clinical Trials
Other England Clinical Trials
Other London Clinical Trials
Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides
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