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BCX-1777 in Treating Patients With Refractory Hematologic Cancer 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 BCX-1777 in Treating Patients With Refractory Hematologic Cancer conditions. Clinical Trials Search.org is a site devoted 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 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 BCX-1777 in Treating Patients With Refractory Hematologic Cancer. BCX-1777 in Treating Patients With Refractory Hematologic Cancer 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 BCX-1777 in Treating Patients With Refractory Hematologic Cancer clinical trial. Subjects frequently obtain the most expert healthcare possible for their BCX-1777 in Treating Patients With Refractory Hematologic Cancer 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 > 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 Lymphoma Studies:
1. Phase I Study of Anti-Tac(Fv)-PE38 (LMB-2), a Recombinant Single-Chain Immunotoxin for Treatment of Tac-Expressing Malignancies
2. Chemotherapy Plus Donor White Blood Cell Infusion in Treating Patients With Relapsed Hematologic Cancer Following Donor Peripheral Stem Cell Transplantation
3. Ultraviolet-B Light Therapy and Allogeneic Stem Cell Transplantation in Treating Patients With Hematologic Malignancies
4. Pyroxamide in Treating Patients With Advanced Cancer
5. Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors
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BCX-1777 in Treating Patients With Refractory Hematologic Cancer
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