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Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Myelofibrosis 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 Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Myelofibrosis conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Myelofibrosis Clinical research trials and Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Myelofibrosis 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 Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Myelofibrosis. Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Myelofibrosis 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 Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Myelofibrosis clinical trial. Human subjects often get the best healthcare possible for their Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Myelofibrosis 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 > "C" Clinical Trials Conditions > Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Myelofibrosis  Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Myelofibrosis
Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Myelofibrosis
For Condition: Essential Thrombocythemia,Polycythemia Vera,idiopathic myelofibrosis,Agnogenic Myeloid Metaplasia
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Fred Hutchinson Cancer Research Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have myelofibrosis.
Details: OBJECTIVES: I. Determine the ability of myeloablative chemotherapy followed by peripheral blood stem cell (PBSC) transplantation to restore effective marrow hematopoieses in patients with advanced idiopathic myelofibrosis or myelofibrosis secondary to other myeloproliferative disorders. II. Determine the ability of this regimen to palliate symptoms and prolong survival in these patients. III. Determine if there is evidence of clonal hematopoieses before PBSC mobilization, in the PBSC product, and after transplantation in these patients. IV. Correlate the properties of the peripheral blood before mobilization and the PBSC product with engraftment in these patients. V. Correlate the markers of angiogenesis with clinical parameters in these patients. PROTOCOL OUTLINE: Patients with evidence of leukemic progression receive cytoreduction therapy consisting of idarubicin IV on days 1-3 and cytarabine IV continuously over days 1-7 followed by filgrastim (G-CSF) subcutaneously (SC) daily until blood counts recover and leukapheresis is completed. Patients undergo leukapheresis beginning when blood counts recover and continuing until the target number of cells are collected. Patients with no evidence of leukemic progression receive filgrastim SC daily until leukapheresis is completed. Patients undergo leukapheresis beginning on day 4 and continuing until the target number of cells are collected. Patients receive myeloablative therapy consisting of oral busulfan every six hours on days -5 to -2. Patients with leukemic progression begin myeloablative therapy at least 28 days after completion of chemotherapy. Patients receive autologous peripheral blood stem cells IV on day 0. Patients are followed at 1 month, 3 months, 1 year, and then annually thereafter. PROJECTED ACCRUAL: A maximum of 50 patients will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /75 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of idiopathic myelofibrosis or other myeloproliferative disorder with myelofibrosis - Evidence of advanced disease or hematologic abnormalities due to severe fibrosis such as 1 or more of the following poor prognostic factors: Hemoglobin less than 10 g/dL; Platelet count less than 100,000/mm3; WBC less than 4,000/mm3; Symptomatic splenomegaly; Constitutional symptoms inadequately controlled with low dose chemotherapy; Abnormal karyotype - Patients without evidence of advanced disease undergo PBSC harvest and transplantation is delayed until there is evidence of disease progression - Leukemia progression (greater than 15% peripheral blood blasts) allowed if the history of a chronic myeloproliferative disorder of at least 6 months duration is well documented - Ineligible for or refusal of allogeneic transplantation - No other cause of myelofibrosis other than myeloproliferative disorders, such as the following: Metastatic carcinoma; Lymphoma; Hairy cell leukemia; Myelodysplastic syndrome; De novo acute leukemia; Collagen vascular disorders; Granulomatous infections --Prior/Concurrent Therapy-- - See Disease Characteristics - At least 7 days since prior hydroxyurea --Patient Characteristics-- - Age: 75 and under - Performance status: Not specified - Life expectancy: Not specified - Hematopoietic: See Disease Characteristics; WBC no greater than 30,000/mm3 (may be reduced to less than 30,000/mm3 using hydroxyurea or induction chemotherapy) - Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN)*; Transaminases no greater than 2 times ULN*; * Unless due to extramedullary hematopoiesis in the liver - Renal: Creatinine no greater than 2 times normal OR Creatinine clearance at least 50% - Cardiovascular: No prior or active congestive heart failure*; LVEF at least 50%*; *If receiving study cytoreductive therapy - Pulmonary: Total lung capacity at least 50% predicted OR Corrected DLCO at least 50% predicted - Other: No active infection; No poorly controlled seizure disorders; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective barrier contraception; HIV negative
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeanneAnderson, Study Chair, Fred Hutchinson Cancer Research Center
University of Illinois College of Medicine
Chicago, Illinois, 60612
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Hopital Saint-Louis
Paris, , 75475
France
Katmai Oncology Group
Anchorage, Alaska, 99508-4627
United States
New York Presbyterian Hospital - Cornell Campus
New York City, New York, 10021
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Washington University Siteman Cancer Center
St. Louis, Missouri, 63110
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Addenbrooke's NHS Trust
Cambridge, England, CB2 2QQ
United Kingdom
Additional Information:
Study ID Numbers: CDR0000068240; NCI-G00-1866,MCC-12245,MCC-IRB-5698,FHCRC-1006.00
Study Start Date: May 2000
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006367
Other Polycythemia Vera Studies:
1. Tipifarnib in Treating Patients With Myelofibrosis and Myeloid Metaplasia
2. Chemotherapy in Treating Children With Down Syndrome Plus Myeloproliferative Disorder, Acute Myelogenous Leukemia, or Myelodysplastic Syndrome
3. Combination Chemotherapy Plus Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloproliferative Disorders
4. Imatinib Mesylate in Treating Patients With Myelofibrosis
5. Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Myelofibrosis
Related Studies:
Other Polycythemia Vera Clinical Trials
Other Clinical Trials
Other Paris Clinical Trials
Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Patients With Myelofibrosis
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