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Tipifarnib in Treating Patients With Myelofibrosis and Myeloid Metaplasia Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Tipifarnib in Treating Patients With Myelofibrosis and Myeloid Metaplasia conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Tipifarnib in Treating Patients With Myelofibrosis and Myeloid Metaplasia Clinical research trials and Tipifarnib in Treating Patients With Myelofibrosis and Myeloid Metaplasia healthcare trials occur in a lot of 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 does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Tipifarnib in Treating Patients With Myelofibrosis and Myeloid Metaplasia. Tipifarnib in Treating Patients With Myelofibrosis and Myeloid Metaplasia Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Tipifarnib in Treating Patients With Myelofibrosis and Myeloid Metaplasia clinical trial. Test subjects typically receive the most effective healthcare possible for their Tipifarnib in Treating Patients With Myelofibrosis and Myeloid Metaplasia condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Tipifarnib in Treating Patients With Myelofibrosis and Myeloid Metaplasia  Tipifarnib in Treating Patients With Myelofibrosis and Myeloid Metaplasia
Tipifarnib in Treating Patients With Myelofibrosis and Myeloid Metaplasia
For Condition: chronic idiopathic myelofibrosis,Polycythemia Vera,Essential Thrombocythemia
Status: No longer recruiting
Sponsor(s): Mayo Clinic Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of tipifarnib in treating patients who have myelofibrosis with myeloidmetaplasia.
Details: OBJECTIVES: - Determine the response rate in patients with myelofibrosis with myeloid metaplasia treated with tipifarnib. - Determine the toxicity of this drug in these patients. - Determine the effect of this drug on disease-associated anemia, palpable splenomegaly, and hypercatabolic symptoms in these patients. - Determine the effect of this drug on the pathologic increase in circulating myeloid progenitors from baseline to after the first course in these patients. - Correlate response/relapse in these patients with in vitro myeloid colony sensitivity to this drug. - Determine the effect of this drug on bone marrow histologic features (osteosclerosis, reticulin fibrosis, and angiogenesis) in these patients. OUTLINE: This is a multicenter study. Patients receive oral tipifarnib twice daily on days 1-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 2 years. PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study within 15 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed myelofibrosis with myeloid metaplasia - Agnogenic myeloid metaplasia - Post-polycythemic myeloid metaplasia - Post-thrombocythemic myeloid metaplasia - Bone marrow must show reticulin fibrosis and peripheral blood smear must show leukoerythroblastosis and dacrocytosis - Bone marrow must not show evidence of other conditions associated with myelofibrosis, including the following: - Metastatic carcinoma - Lymphoma - Myelodysplasia - Hairy cell leukemia - Mast cell disease - Acute leukemia (including M7 type) - Acute myelofibrosis - Absence of chromosomal translocation t(9:22) by bone marrow chromosome analysis or peripheral blood or bone marrow fluorescent in situ hybridization (FISH) - At least 1 of the following must be present: - Anemia evidenced by hemoglobin less than 10 g/dL - Palpable hepatosplenomegaly PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - See Disease Characteristics - Absolute neutrophil count at least 750/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than upper limit of normal (ULN) - AST no greater than 2.5 times ULN - Alkaline phosphatase no greater than 3 times ULN (unless secondary to disease) Renal - Creatinine no greater than 1.5 times ULN Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other concurrent uncontrolled illness or comorbid condition that would preclude study participation - No ongoing or active infection - No psychiatric illness or social situation that would preclude study participation - No known quinolone sensitivity PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent epoetin alfa - No concurrent prophylactic colony-stimulating factors (filgrastim [G-CSF] or sargramostim [GM-CSF]) - No concurrent thalidomide Chemotherapy - More than 2 weeks since prior cytotoxic chemotherapy Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified Other - More than 2 weeks since prior myelosuppressive agents - No other concurrent therapy directed at the disease
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RubenMesa, Study Chair, Mayo Clinic Cancer Center
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Howard University College of Medicine
Washington D.C., District of Columbia, 20059
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792
United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259
United States
Additional Information:
Study ID Numbers: CDR0000257568; NCI-5576,MAYO-MC0184
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00047190
Other Polycythemia Vera Studies:
1. Chemotherapy in Treating Children With Down Syndrome Plus Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome
2. Low-Dose Total-Body Irradiation, Fludarabine, and Alemtuzumab Followed By Allogeneic Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorder or Myelodysplastic Syndrome
3. Imatinib Mesylate in Treating Patients With Myelofibrosis
4. Tipifarnib in Treating Patients With Myelofibrosis and Myeloid Metaplasia
5. Combination Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorders
Related Studies:
Other Polycythemia Vera Clinical Trials
Other District of Columbia Clinical Trials
Other Washington D.C. Clinical Trials
Tipifarnib in Treating Patients With Myelofibrosis and Myeloid Metaplasia
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