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Imatinib Mesylate in Treating Patients With Myelofibrosis Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Imatinib Mesylate in Treating Patients With Myelofibrosis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Imatinib Mesylate in Treating Patients With Myelofibrosis Clinical research trials and Imatinib Mesylate in Treating Patients With Myelofibrosis medical trials happen in hundreds 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 usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Imatinib Mesylate in Treating Patients With Myelofibrosis. Imatinib Mesylate in Treating Patients With Myelofibrosis Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Imatinib Mesylate in Treating Patients With Myelofibrosis clinical trial. Participants frequently get the best healthcare available for their Imatinib Mesylate in Treating Patients With Myelofibrosis condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Imatinib Mesylate in Treating Patients With Myelofibrosis  Imatinib Mesylate in Treating Patients With Myelofibrosis
Imatinib Mesylate in Treating Patients With Myelofibrosis
For Condition: Essential Thrombocythemia,Polycythemia Vera,chronic idiopathic myelofibrosis,Chronic Myelomonocytic Leukemia
Status: Recruiting
Sponsor(s): University of Chicago Cancer Research Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Imatinib mesylate may stop the growth of myelofibrosis by blocking certain enzymes necessary for cell growth. PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have myelofibrosis.
Details: OBJECTIVES: - Determine the complete and partial response rate in patients with myelofibrosis treated with imatinib mesylate. - Determine the safety of this drug in these patients. - Determine the effects of this drug on the bone marrow morphology, including effects on bone marrow fibrosis, osteosclerosis, and cellularity, in these patients. - Assess the effects of this drug on surrogate biologic endpoints, including platelet-derived growth factor (PDGFR) expression by immunohistochemistry, PDGFR signaling, and circulating progenitor (CD34 positive) cells, in these patients. - Determine the effects of this drug on bone marrow cytogenetics in patients with an abnormal karyotype. OUTLINE: This is a multicenter study. Patients are stratified according to Dupriez risk score (low vs intermediate vs high). Patients receive oral imatinib mesylate once or twice daily on days 1-28. Courses repeat every 28 days for 12 months in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 3-17.5 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - One of the following diagnoses: - Histologically confirmed myeloid metaplasia with myelofibrosis (MMM) - All subtypes eligible - Chronic idiopathic myelofibrosis - Agnogenic myeloid metaplasia - Post-thrombocythemic or post-polycythemic myelofibrosis - Must meet the standard Italian Diagnostic Criteria for MMM OR - Histologically confirmed chronic myelomonocytic leukemia (CMMOL) with t(5;12)(q31;p12) or TEL-platelet-derived growth factor (PDGFR)-beta rearrangement - Patients with CMMOL and the t(5;7)(q33;q11.2) or other chromosomal translocations resulting in activation of PDGFR are also eligible - Must meet the standard World Health Organization Diagnostic Criteria for CMMOL - Meets criteria for 1 of the following: - Anemia (hemoglobin less than 11 g/dL) - Splenomegaly by palpation and ultrasound - Philadelphia chromosome or bcr-abl rearrangement negative PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics Hepatic: - Bilirubin less than 1.5 times upper limit of normal (ULN) - AST/ALT less than 2.5 times ULN (unless due to liver involvement with disease) Renal: - Creatinine less than 2 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 barrier contraception during and for up to 3 months after study participation - No prior allergic reactions attributed to compounds of similar chemical or biological composition to imatinib mesylate - No other uncontrolled concurrent illness - No ongoing or active infection - No psychiatric illness or social situations that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior epoetin alfa or filgrastim (G-CSF) - No concurrent biologic agents Chemotherapy: - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered - No concurrent chemotherapy Endocrine therapy: - At least 4 weeks since prior androgenic steroids - No concurrent androgenic steroids Radiotherapy: - At least 4 weeks since prior radiotherapy, including splenic irradiation - No concurrent radiotherapy Surgery: - Not specified Other: - At least 4 weeks since other prior therapy - Any number of prior treatment regimens allowed - No other concurrent investigational or commercial anticancer agents or therapies - No concurrent combination antiretroviral therapy for HIV-positive patients - No concurrent therapeutic anticoagulation with warfarin - Concurrent therapeutic anticoagulation with low-molecular weight heparin (e.g., enoxaparin) or unfractionated heparin allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
OlatoyosiOdenike, Study Chair, University of Chicago Cancer Research Center
Evanston Northwestern Health Care - Evanston Hospital *Recruiting*
Evanston, Illinois, 60201-1781
United States
Recruiting Gregory Masters 847-570-2515
Louis A. Weiss Memorial Hospital *Recruiting*
Chicago, Illinois, 60640
United States
Recruiting Stuart Krauss 773-878-8700
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting David Taber 800-284-7370
Decatur Memorial Hospital Cancer Care Institute *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6603
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637
United States
Recruiting Olatoyosi Odenike 773-702-3354
Oncology/Hematology Associates of Central Illinois, P.C. *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting John Kugler 309-636-3605
Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood, Illinois, 60153
United States
Recruiting John Godwin 708-327-3180
Fort Wayne Medical Oncology and Hematology, Incorporated *Recruiting*
Ft. Wayne, Indiana, 46885-5099
United States
Recruiting David Sciortino 219-484-8830
Central Illinois Hematology Oncology Center *Recruiting*
Springfield, Illinois, 62701
United States
Recruiting Edem Agamah 217-525-2500
Oncology Care Associates, P.L.L.C. *Recruiting*
Saint Joseph, Michigan, 49085
United States
Recruiting Eric Lester 269-985-0029
LaGrange Memorial Hospital *Recruiting*
LaGrange, Illinois, 60525
United States
Recruiting James Hannigan 708-579-3418
Ingalls Memorial Hospital *Recruiting*
Harvey, Illinois, 60426
United States
Recruiting Mark Kozloff 708-333-2300
Additional Information:
Study ID Numbers: CDR0000069381; NCI-5669,UCCRC-NCI-5669
Study Start Date:
Record last reviewed: August 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039416
Other Polycythemia Vera Studies:
1. Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome
2. A Phase I Study of DT388GMCSF Fusion Protein in AML and CMML
3. Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer
4. Bevacizumab in Treating Patients With Myelodysplastic Syndrome
5. Idarubicin, Cytarabine, and Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia Secondary to Myelodysplastic Syndrome
Related Studies:
Other Polycythemia Vera Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Imatinib Mesylate in Treating Patients With Myelofibrosis
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