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BCX-1777 in Treating Patients With Refractory Hematologic Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on BCX-1777 in Treating Patients With Refractory Hematologic Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. BCX-1777 in Treating Patients With Refractory Hematologic Cancer Clinical research trials and BCX-1777 in Treating Patients With Refractory Hematologic Cancer medical trials happen in hundreds of localities throughout 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 typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like BCX-1777 in Treating Patients With Refractory Hematologic Cancer. BCX-1777 in Treating Patients With Refractory Hematologic Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a BCX-1777 in Treating Patients With Refractory Hematologic Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their BCX-1777 in Treating Patients With Refractory Hematologic Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > BCX-1777 in Treating Patients With Refractory Hematologic Cancer  BCX-1777 in Treating Patients With Refractory Hematologic Cancer
BCX-1777 in Treating Patients With Refractory Hematologic Cancer
For Condition: chronic myeloproliferative disorders,Lymphoma,myelodysplastic and myeloproliferative diseases,Leukemia,plasma cell neoplasm
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 trial to study the effectiveness of BCX-1777 in treating patients who have refractoryhematologic cancer.
Details: OBJECTIVES: - Determine the maximum tolerated dose of BCX-1777 in patients with refractory hematologic malignancies. - Determine the safety profile of this drug in these patients. - Determine the pharmacokinetics of this drug in these patients. - Determine, preliminarily, the efficacy of this drug in these patients. OUTLINE: This is an open-label, non-randomized, dose-escalation, multicenter study. Patients receive BCX-1777 IV over 30 minutes once on day 1 and twice daily on days 2-5. Treatment repeats every 21 days for a total of 2 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 preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 14 and 30 days. PROJECTED ACCRUAL: A total of 12-24 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven hematologic malignancy - Refractory disease for which no better treatment is available - Measurable (e.g., at least 1 lymph node at least 1.5 cm in diameter) or evaluable (e.g., acute leukemia) disease - No cutaneous T-cell lymphoma - Not a candidate for stem cell transplantation - No CNS leukemia or lymphoma requiring intrathecal therapy or craniospinal radiotherapy PATIENT CHARACTERISTICS: Age - 16 and over Performance status - ECOG 0-2 Life expectancy - At least 3 months Hematopoietic - Platelet count at least 50,000/mm^3 - Neutrophil count at least 1,000/mm^3 (except for patients with acute leukemia or in the acute leukemic phase of a hematologic malignancy) Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) (unless due to Gilbert's syndrome) - AST and ALT no greater than 2 times ULN - No chronic symptomatic or asymptomatic infection due to hepatitis B or C Renal - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 60 mL/min Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - No concurrent active serious infection not controlled by oral or IV antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No concurrent antibody therapy - No concurrent immunotherapy - No concurrent vaccine therapy - No concurrent angiogenesis inhibitor therapy - No concurrent sargramostim (GM-CSF) - No concurrent gene therapy Chemotherapy - More than 7 days since prior chemotherapy - No concurrent chemotherapy Endocrine therapy - No concurrent hormonal therapy - Concurrent stable-dose steroid therapy allowed Radiotherapy - See Disease Characteristics - No concurrent radiotherapy Surgery - Not specified Other - More than 7 days since prior investigational antileukemic agents - No packed red blood cell or platelet transfusion or any other citrate-containing blood products within 30 minutes before or after study drug - No other concurrent anticancer or experimental agents - No concurrent matrix metalloprotease inhibitors
Total Enrollment:
Location and Contact Information:
Overall Study Official:
TonyMorris, Study Chair, Pharma Research Corporation
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Anjali Advani 216-445-9354
USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles, California, 90033-0804
United States
Recruiting Alexandra Levine 323-865-3913
Mount Sinai School of Medicine *Recruiting*
New York City, New York, 10029
United States
Recruiting Luis Isola 212-241-6021
New York Weill Cornell Cancer Center at Cornell University *Recruiting*
New York City, New York, 10021
United States
Recruiting Richard Furman 212-746-2932
Shands Cancer Center at the University of Florida Health Science Center *Recruiting*
Gainesville, Florida, 32610-0296
United States
Recruiting Katarzyna Finiewicz 352-392-4925
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting James Foran 205-975-0694
Additional Information:
Study ID Numbers: CDR0000299049; BIOCRYST-1777BC-102
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00066235
Other Leukemia Studies:
1. Bone Marrow Transplantation in Treating Patients With Hematologic Cancers
2. T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Treated Donor T Cells After Immunoablative Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Hematologic Malignancies
3. Donor Stem Cell Transplantation in Treating Patients With Myelodysplastic Syndrome and Myeloproliferative Disorders
4. Sirolimus in Preventing Graft-Versus-Host Disease in Patients With Hematologic Malignancies Who Are Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
5. Ultraviolet-B Light Therapy and Allogeneic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies
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BCX-1777 in Treating Patients With Refractory Hematologic Cancer
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