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Bexarotene and Interferon alfa in Treating Patients With Cutaneous T-Cell Lymphoma Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Bexarotene and Interferon alfa in Treating Patients With Cutaneous T-Cell Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Bexarotene and Interferon alfa in Treating Patients With Cutaneous T-Cell Lymphoma Clinical research trials and Bexarotene and Interferon alfa in Treating Patients With Cutaneous T-Cell Lymphoma healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Bexarotene and Interferon alfa in Treating Patients With Cutaneous T-Cell Lymphoma. Bexarotene and Interferon alfa in Treating Patients With Cutaneous T-Cell Lymphoma Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Bexarotene and Interferon alfa in Treating Patients With Cutaneous T-Cell Lymphoma clinical trial. Subjects frequently obtain the most expert healthcare possible for their Bexarotene and Interferon alfa in Treating Patients With Cutaneous T-Cell Lymphoma condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Bexarotene and Interferon alfa in Treating Patients With Cutaneous T-Cell Lymphoma  Bexarotene and Interferon alfa in Treating Patients With Cutaneous T-Cell Lymphoma
Bexarotene and Interferon alfa in Treating Patients With Cutaneous T-Cell Lymphoma
For Condition: stage 4 cutaneous T-cell lymphoma,recurrent cutaneous T-cell lymphoma,stage 3 cutaneous T-cell lymphoma,stage 1 cutaneous T-cell lymphoma,stage 2 cutaneous T-cell lymphoma
Status: Recruiting
Sponsor(s): Memorial Sloan-Kettering Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of cancer cells. Combining chemotherapy with interferon alfa may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combining bexarotene with interferon alfa in treating patients who have cutaneous T-cell lymphoma.
Details: OBJECTIVES: - Determine the response rate and response duration in patients with cutaneous T-cell lymphoma when treated with bexarotene and, in the absence of a complete response, interferon alfa. - Determine the safety and toxicity in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral bexarotene once daily for 8 weeks. Patients with a complete response (CR) after 8 weeks continue bexarotene alone for at least another 8 weeks in the absence of unacceptable toxicity. Patients who progress or relapse during bexarotene therapy or who achieve less than a CR after 8 weeks begin receiving interferon alfa subcutaneously 3 times a week and oral bexarotene daily for at least another 8 weeks in the absence of continuing disease progression or unacceptable toxicity. Patients are followed at 4 weeks. PROJECTED ACCRUAL: A total of 20-45 patients will be accrued for this study within 2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed cutaneous T-cell lymphoma - Stage IB, IIA, IIB, III, or IV - Measurable or assessable disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - Hemoglobin at least 9 g/dL - WBC at least 1,500/mm^3 - Platelet count at least 70,000/mm^3 Hepatic: - Bilirubin no greater than 2.0 mg/dL - SGOT and SGPT no greater than 3 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 3 times ULN - Fasting triglyceride normal (normalization with an antilipemic agent is allowed prior to study) - No severe decompensated liver disease (e.g., cirrhosis, autoimmune hepatitis, or any other significant liver dysfunction) Renal: - Calcium no greater than 11.5 mg/dL - Creatinine no greater than 2 times ULN Cardiovascular: - No myocardial infarction in the past 6 months - No unstable angina - No class III or IV congestive heart failure - No ventricular tachyarrhythmias Pulmonary: - No pulmonary infiltrates or clinical pulmonary impairment Other: - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use 2 forms of effective contraception for 1 month before, during, and for 1 month after study therapy - No known allergy or sensitivity to interferon alfa or bexarotene or other components of study drugs - No uncontrolled thyroid disorder - No other concurrent serious medical illness that would preclude study - No infection - No history of pancreatitis - No history of neuropsychiatric disorders requiring hospitalization - No history of autoimmune disease that would pose significant risk - Must be willing and able to avoid prolonged exposure to the sun or ultraviolet light PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No concurrent systemic anticancer chemotherapy Endocrine therapy: - No concurrent systemic corticosteroids Radiotherapy: - No concurrent localized radiotherapy to target lesions unless considered - to have shown progressive disease Surgery: - Not specified Other: - At least 30 days since prior systemic doses of more than 15,000 IU per day of vitamin A or any other retinoid class drug - At least 30 days since prior participation in any other investigational drug study - No concurrent systemic anti-psoriatic drugs or therapies - No concurrent systemic other anticancer drugs or therapies - No concurrent gemfibrozil - No other concurrent investigational medication
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidStraus, Study Chair, Memorial Sloan-Kettering Cancer Center
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Kenneth Hymes 212-263-7226
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Madeleine Duvic 713-745-1113
University of Miami Sylvester Cancer Center *Recruiting*
Miami, Florida, 33136
United States
Recruiting William Harrington 305-243-4994
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting David Straus 212-639-8365
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Alain Rook 215-662-6751
Additional Information:
Study ID Numbers: CDR0000069202; MSKCC-01128,NCI-G01-2049
Study Start Date:
Record last reviewed: February 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030849
Other Stage 4 Cutaneous T-Cell Lymphoma Studies:
1. Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides
2. Chemotherapy and Photodynamic Therapy in Treating Patients With Cutaneous T-Cell Lymphoma
3. Bexarotene and Interferon alfa in Treating Patients With Cutaneous T-Cell Lymphoma
4. O(6)-benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma
Related Studies:
Other stage 4 cutaneous T-cell lymphoma Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Bexarotene and Interferon alfa in Treating Patients With Cutaneous T-Cell Lymphoma
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