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Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers Clinical research trials and Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers health trials occur in a lot of of places 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 typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers. Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers clinical trial. Human subjects frequently get the finest healthcare available for their Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers  Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers
Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers
For Condition: relapsing chronic myelogenous leukemia,previously treated myelodysplastic syndromes,blastic phase chronic myelogenous leukemia,refractory anemia with excess blasts in transformation,recurrent adult acute myeloid leukemia,refractory anemia with excess blasts,Chronic Myelomonocytic Leukemia,secondary acute myeloid leukemia
Status: No longer recruiting
Sponsor(s): University of Maryland Greenebaum Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies such as bevacizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment for hematologic cancer. PURPOSE: Phase II trial to study the effectiveness of bevacizumab combined with cytarabine and mitoxantrone in treating patients who have hematologic cancer.
Details: OBJECTIVES: - Determine the clinical effectiveness of bevacizumab, cytarabine, and mitoxantrone in patients with poor-risk hematologic malignancies. - Determine the toxic effects of this regimen in these patients. - Determine whether this regimen can induce cell apoptosis in these patients. - Determine the effects of bevacizumab on coagulation profiles in these patients. OUTLINE: This is a multicenter study. Patients receive cytarabine IV continuously over 72 hours on days 1-3, mitoxantrone IV over 30-60 minutes on day 4, and bevacizumab IV over 90 minutes on day 8 in the absence of disease progression or unacceptable toxicity. Patients achieving partial or complete remission may receive a second course of therapy beginning approximately 30 days after the completion of the first course. Patients are followed until death. PROJECTED ACCRUAL: A total of 12-45 patients will be accrued for this study within 1-3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed poor-risk hematologic malignancy - Relapsed or refractory acute myelogenous leukemia (AML) - Primary induction failure - Myelodysplasia(MDS)-related AML - Secondary AML - Relapsed or refractory MDS - Primary induction failure - Refractory anemia with excess blasts (RAEB) - RAEB in transformation - Chronic myelomonocytic leukemia - Chronic myelogenous leukemia in blast crisis - Failure of prior primary induction therapy or relapse after achieving complete remission allowed only if no more than 3 courses of prior induction/reinduction therapy were received - No hyperleukocytosis (50,000 or more leukemic blasts/mm3) - No active CNS leukemia PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - See Disease Characteristics - No disseminated intravascular coagulation Hepatic: - AST/ALT no greater than 2 times normal - Alkaline phosphatase no greater than 2 times normal - Bilirubin no greater than 1.5 times normal Renal: - Creatinine no greater than 1.5 times normal Cardiovascular: - LVEF at least 45% by MUGA or echocardiogram - No myocardial infarction within the past 3 months - No history of severe coronary artery disease - No cardiomyopathy - No New York Heart Association class III or IV heart disease (congestive heart failure) Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No active uncontrolled infection - No history of cytarabine-related neurotoxicity - No evidence of graft-versus-host disease PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 1 week since prior hematopoietic growth factors including epoetin alfa, filgrastim (G-CSF), and sargramostim (GM-CSF) - At least 1 week since prior interleukin-3 or interleukin-11 - At least 4 weeks since prior autologous stem cell transplantation - At least 90 days since prior allogeneic stem cell transplantation - No other concurrent immunotherapy Chemotherapy: - See Disease Characteristics - At least 3 weeks since prior chemotherapy and recovered - No prior cytarabine administered as a 72-hour continuous infusion followed by mitoxantrone IV over 30 minutes - No other concurrent chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No concurrent radiotherapy Surgery: - Not specified Other: - At least 2 weeks since prior immunosuppressive therapy - No other concurrent investigational or commercially available antitumor therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JudithKarp, Study Chair, University of Maryland Greenebaum Cancer Center
Marlene and Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, 21201
United States
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia, 30342-1601
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
United States
Additional Information:
Study ID Numbers: CDR0000068576; NCI-2490,MSGCC-0076
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00015951
Other Blastic Phase Chronic Myelogenous Leukemia Studies:
1. Busulfan Compared With Cyclophosphamide in Patients Undergoing Total-Body Irradiation Plus Peripheral Stem Cell Transplantation for Advanced Myelodysplastic Syndrome or Related Acute Myeloid Leukemia
2. Thalidomide in Treating Patients With Myelodysplastic Syndrome
3. Decitabine Compared With Supportive Care in Treating Patients With Advanced Myelodysplastic Syndromes
4. Decitabine in Treating Patients With Myelodysplastic Syndrome
5. Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Related Studies:
Other blastic phase chronic myelogenous leukemia Clinical Trials
Other Maryland Clinical Trials
Other Baltimore Clinical Trials
Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers
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