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506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about 506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma Clinical research trials and 506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma healthcare trials happen in many of places across 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 effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as 506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma. 506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a 506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their 506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "5" Clinical Trials Conditions > 506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma  506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma
506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma
For Condition: recurrent cutaneous T-cell lymphoma,recurrent mycosis fungoides/Sezary syndrome
Status: No longer recruiting
Sponsor(s): M.D. Anderson 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. PURPOSE: Phase II trial to study the effectiveness of 506U78 in treating patients who have recurrent or refractory cutaneous T-cell lymphoma.
Details: OBJECTIVES: - Determine the response rate, failure-free survival, and progression-free survival of patients with recurrent or refractory cutaneous T-cell lymphoma treated with 506U78. - Determine the toxicity of this drug in these patients - Study the pharmacokinetics of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Treatment continues every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 months. PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed relapsed or refractory cutaneous T-cell lymphoma - Large cell transformation of cutaneous T-cell lymphoma allowed - No active CNS disease PATIENT CHARACTERISTICS: Age: - 16 and over Performance status: - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,000/mm^3* - Platelet count at least 100,000/mm^3* NOTE: *Unless attributable to marrow or splenic involvement by lymphoma Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGPT no greater than 2.5 times ULN Renal: - Creatinine clearance greater than 50 mL/min Cardiovascular - No history of symptomatic cardiac dysfunction - No history of pericardial effusion Other: - HIV negative - No grade 2 or greater sensory or motor neuropathy - No history of seizures - No other malignancy within the past 5 years except curatively treated basal cell carcinoma of the skin of carcinoma in situ of the cervix - No medical, psychiatric, or social condition that would preclude study - No other concurrent serious illness or active infection - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior stem cell or bone marrow transplantation (BMT) - No more than 1 prior immunotherapy regimen - No more than 3 prior systemic regimens with denileukin diftitox - At least 3 weeks since prior biologic therapy - No concurrent BMT Chemotherapy: - No prior 506U78 - No more than 3 prior systemic chemotherapy regimens comprising any of the following: - Oral methotrexate - Topical mechlorethamine - At least 3 weeks since prior chemotherapy - No other concurrent chemotherapy Endocrine therapy: - At least 3 weeks since prior anticancer endocrine therapy - No concurrent topical or systemic steroids Radiotherapy: - At least 3 weeks since prior radiotherapy - No more than 3 prior systemic regimens comprising any of the following: - Total skin electron beam therapy - Spot radiotherapy Surgery: - Not specified Other: - No more than 3 prior systemic regimens comprising any of the following: - Oral retinoids - Ultraviolet therapy (PUVA) - At least 3 weeks since prior anticancer therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AndreGoy, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
CCOP - M.D. Anderson Research Base
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000067970; MDA-ID-99213,NCI-86
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005982
Other Recurrent Mycosis Fungoides/sezary Syndrome Studies:
1. MDX-060 Monoclonal Antibody in Treating Patients With Refractory or Relapsed Lymphoma
2. O(6)-benzylguanine and Carmustine in Treating Patients With Stage I or Stage II Cutaneous T-cell Lymphoma
3. Dexamethasone Followed by Denileukin Diftitox in Treating Patients With Persistent or Recurrent T-Cell Lymphoma
4. Bexarotene and Interferon alfa in Treating Patients With Cutaneous T-Cell Lymphoma
5. Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Related Studies:
Other recurrent mycosis fungoides/Sezary syndrome Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
506U78 in Treating Patients With Recurrent or Refractory Cutaneous T-cell Lymphoma
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