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Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome Clinical research trials and Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome healthcare trials happen in a lot of of localities across 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 generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome. Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome clinical trial. Human subjects often receive the most effective healthcare possible for their Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome  Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome
Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome
For Condition: Cutaneous T-Cell Lymphoma,mycosis fungoides and Sezary syndrome
Status: Recruiting
Sponsor(s): Robert H. Lurie 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 temozolomide in treating patients who have mycosis fungoides or Sezary syndrome that has not responded to previous treatment.
Details: OBJECTIVES: - Determine the response rate to temozolomide in patients with relapsed mycosis fungoides or Sezary syndrome. - Determine the toxic effects of this drug in these patients. - Correlate pretreatment AGT activity in tumor cells with response to this drug in these patients. OUTLINE: This is a multicenter study. Patients receive oral temozolomide once daily on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity for a maximum of 1 year. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 12-37 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 mycosis fungoides or Sezary syndrome - Stage IB-IVB disease - Must have failed at least one prior systemic therapy - Generalized erythroderma allowed - Measurable disease and at least one indicator lesion OR evaluable disease for erythrodermic patients only - Prior radiotherapy to areas of measurable disease allowed if disease progression is present in the site or if measurable disease is present outside irradiation port PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - WHO 0-2 Life expectancy: - At least 3 months Hematopoietic: - WBC at least 3,000/mm^3 - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 2.2 mg/dL - SGOT or SGPT no greater than 2 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2 times ULN Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - No New York Heart Association class III or IV heart disease - No clinically significant peripheral venous insufficiency Other: - HIV negative - No poorly controlled diabetes mellitus - No acute infection requiring IV antibiotics - No other medical condition that would prevent ingestion or absorption of oral medication - No other neoplasm within the past 5 years except curatively treated squamous cell or basal cell skin cancer, melanoma in situ, or carcinoma in situ of the cervix - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior biologic therapy and recovered - No concurrent growth factors or epoetin alfa Chemotherapy: - At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: - At least 4 weeks since prior topical steroids Radiotherapy: - See Disease Characteristics - At least 2 weeks since prior radiotherapy for local control or palliation and recovered Surgery: - Recovered from prior major surgery Other: - No other concurrent investigational drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TimothyKuzel, Study Chair, Robert H. Lurie Cancer Center
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611-3013
United States
Recruiting Timothy Kuzel 312-695-4544
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting David Pezen 773-702-9200
Veterans Affairs Medical Center - Lakeside Chicago *Recruiting*
Chicago, Illinois, 60611-4494
United States
Recruiting Timothy Kuzel 312-695-4544
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting Francine Foss 617-636-8884
Additional Information:
Study ID Numbers: CDR0000067325; NU-FDA97H3,NCI-G99-1597
Study Start Date:
Record last reviewed: February 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004106
Other Mycosis Fungoides And Sezary Syndrome Studies:
1. Tipifarnib in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
2. BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma
3. Interleukin-12 and Interleukin-2 in Treating Patients With Mycosis Fungoides
4. Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome
5. Reduced-Intensity Regimen Before Bone Marrow Transplantation in Treating Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma
Related Studies:
Other mycosis fungoides and Sezary syndrome Clinical Trials
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Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome
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