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BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma Clinical research trials and BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma. BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma clinical trial. Human subjects often get the best healthcare possible for their BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma  BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma
BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma
For Condition: mycosis fungoides and Sezary syndrome,Cutaneous T-Cell Lymphoma
Status: Recruiting
Sponsor(s): BioCryst Pharmaceuticals ,
Synopsis: RATIONALE: BCX-1777 may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. PURPOSE: Phase I/II trial to study the effectiveness BCX-1777 in treating patients who have refractorycutaneous T-cell lymphoma.
Details: OBJECTIVES: - Determine the maximum tolerated dose of BCX-1777 in patients with refractory cutaneous T-cell lymphoma. - Determine the efficacy of this drug in these patients. - Determine the toxicity profile of this drug in these patients. - Correlate plasma concentration of deoxyguanosine with clinical response and toxicity in patients treated with this drug. - Determine the provisional optimal biological dose of this drug in these patients. OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study. - Patients receive BCX-1777 IV over 30 minutes every 12 hours on days 1-5 (a total of 9 doses). Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of BCX-1777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6 patients experience dose-limiting toxicity. - Phase II: Patients receive treatment as in phase I at the MTD of BCX-1777. Patients (including those who respond to treatment) are followed at 14 and 30 days, monthly for 6 months, every 2 months for 6 months, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 3-64 patients (3-24 for phase I and 40 for phase II) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed cutaneous T-cell lymphoma (CTCL) - Any stage except IA patch only - Previously treated according to 1 of the following: - Stage IA plaque, IB, or IIA: - At least 4 prior conventional and/or experimental regimens (topical or systemic, including psoralen-ultraviolet light [PUVA] and systemic corticosteroids) - Stage IIB, III, or IV: - At least 1 prior systemic regimen (systemic corticosteroids and PUVA do not count as systemic regimens for this purpose) NOTE: Repeated use of the same regimen is considered one regimen - Measurable disease PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-3 Life expectancy - At least 3 months Hematopoietic - Granulocyte count at least 2,000/mm^3 - Platelet count at least 75,000/mm^3 - Hemoglobin at least 10.0 g/dL Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) (unless due to Gilbert's syndrome) - ALT no greater than 2 times ULN - Alkaline phosphatase no greater than 2 times ULN - No hepatitis B or C Renal - Creatinine clearance at least 45 mL/min Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - Human T-cell leukemia virus type 1 (HTLV-1) negative - No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No other illness that would limit study participation - No active serious infection not controlled by antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent anticancer antibody therapy - No concurrent anticancer immunotherapy - No concurrent anticancer gene therapy - No concurrent anticancer vaccine therapy - No concurrent anticancer angiogenesis inhibitors - No concurrent sargramostim (GM-CSF) - No concurrent filgrastim (G-CSF) during course 1 of therapy Chemotherapy - More than 21 days since prior chemotherapy unless fully recovered - No concurrent anticancer chemotherapy Endocrine therapy - See Disease Characteristics - More than 2 weeks since prior topical corticosteroids - No concurrent anticancer hormonal therapy Radiotherapy - More than 2 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - More than 2 weeks since prior antineoplastic therapy - More than 21 days since prior investigational agents unless fully recovered - No concurrent citrate-blood products within 30 minutes before or after study treatment - No concurrent anticancer matrix metalloprotease inhibitors - No other concurrent anti-CTCL therapy - No concurrent use of tanning beds - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JimAlexander, Study Chair, Pharma Research Corporation
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Elise Olsen 919-668-5613
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting Francine Foss 617-636-8884
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Andres Forero-Torres 205-934-7167
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Madeleine Duvic 713-745-1113
Additional Information:
Study ID Numbers: CDR0000301763; BIOCRYST-1777BC-103
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00061880
Other Mycosis Fungoides And Sezary Syndrome Studies:
1. Temozolomide in Treating Patients With Mycosis Fungoides or Sezary Syndrome
2. Chemotherapy and Radiation Therapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory T-cell Lymphoma, Hodgkin's Lymphoma, or Non-Hodgkin's Lymphoma
3. BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma
4. Gemcitabine, Carboplatin, and Dexamethasone With or Without Rituximab in Treating Patients With Relapsed or Primary Refractory Lymphoma
5. Interleukin-2 in Treating Patients With Mycosis Fungoides
Related Studies:
Other mycosis fungoides and Sezary syndrome Clinical Trials
Other Alabama Clinical Trials
Other Birmingham Clinical Trials
BCX-1777 in Treating Patients With Refractory Cutaneous T-Cell Lymphoma
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