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Daunorubicin and Cytarabine With or Without Zosuquidar Trihydrochloride in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Daunorubicin and Cytarabine With or Without Zosuquidar Trihydrochloride in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Daunorubicin and Cytarabine With or Without Zosuquidar Trihydrochloride in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia Clinical research trials and Daunorubicin and Cytarabine With or Without Zosuquidar Trihydrochloride in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia healthcare trials happen in a lot of of localities across 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 generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Daunorubicin and Cytarabine With or Without Zosuquidar Trihydrochloride in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia. Daunorubicin and Cytarabine With or Without Zosuquidar Trihydrochloride in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Daunorubicin and Cytarabine With or Without Zosuquidar Trihydrochloride in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia clinical trial. Human subjects often receive the most effective healthcare possible for their Daunorubicin and Cytarabine With or Without Zosuquidar Trihydrochloride in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Daunorubicin and Cytarabine With or Without Zosuquidar Trihydrochloride in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia  Daunorubicin and Cytarabine With or Without Zosuquidar Trihydrochloride in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia
Daunorubicin and Cytarabine With or Without Zosuquidar Trihydrochloride in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia
For Condition: adult acute myeloid leukemia,adult acute monocytic leukemia,Myelodysplastic Syndromes,secondary acute myeloid leukemia
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Zosuquidar trihydrochloride may help daunorubicin and cytarabine kill more cancer cells by making cancer cells more sensitive to the drugs. It is not yet known whether daunorubicin and cytarabine are more effective with or without zosuquidar trihydrochloride in treating acute myeloid leukemia or anemia. PURPOSE: Randomizedphase III trial to compare the effectiveness of daunorubicin combined with cytarabine with or without zosuquidar trihydrochloride in treating older patients who have newly diagnosed acute myeloid leukemia or anemia that has not responded to previous treatment.
Details: OBJECTIVES: - Compare the overall survival and progression-free survival of elderly patients with newly diagnosed acute myeloid leukemia, refractory anemia with excess blasts (RAEB) in transformation, or high-risk RAEB treated with daunorubicin and cytarabine with or without zosuquidar trihydrochloride. - Compare the complete remission rate of patients treated with these regimens. - Compare the toxicity of these regimens in these patients. - Compare the systemic exposure of daunorubicin and cytarabine in patients treated with zosuquidar trihydrochloride vs placebo. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to age (60-69 years vs 70 years and over), disease (refractory anemia with excess blasts [RAEB] vs RAEB in transformation or acute myeloid leukemia [AML]), and disease type (de novo vs secondary). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive daunorubicin IV over 10-15 minutes and zosuquidar trihydrochloride IV over 6 hours on days 1-3. Patients also receive cytarabine IV continuously on days 1-7. - Arm II: Patients receive daunorubicin and cytarabine as in arm I. Patients also receive placebo IV over 6 hours on days 1-3. Beginning on day 12, patients who achieve aplasia receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously (SC) or IV daily until blood counts recover. Patients who have evidence of persistent AML are eligible to receive a second identical course of induction chemotherapy. - Consolidation I (beginning approximately 4 weeks after documentation of complete remission [CR] or measurable remission [MR]): Patients who achieve a CR or MR receive cytarabine IV over 1 hour once or twice daily on days 1-6 and GM-CSF or G-CSF SC or IV beginning on day 7 and continuing until blood counts recover. - Consolidation II: Patients who have maintained peripheral blood evidence of a remission receive daunorubicin, cytarabine, and zosuquidar trihydrochloride or placebo as in induction chemotherapy. Patients also receive GM-CSF or G-CSF SC or IV beginning on day 8 or after last cytarabine dose and continuing until blood counts recover. Patients are followed monthly for 1 year, every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 2 years. PROJECTED ACCRUAL: Approximately 450 patients (225 per treatment arm) will be accrued for this study within 4.1 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 60 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed newly diagnosed acute myeloid leukemia (AML), refractory anemia with excess blasts (RAEB) in transformation (RAEB-T), or high-risk RAEB - AML with 30% myeloblasts on bone marrow aspirate or peripheral blood differential - Any FAB subtype except M3 (i.e., acute promyelocytic leukemia) - RAEB with 11-20% myeloblasts on bone marrow aspirate or peripheral blood differential, provided there are other criteria for high-risk disease - RAEB-T with 21-30% myeloblasts on bone marrow aspirate or peripheral blood differential - No blastic transformation of chronic myelogenous leukemia - Secondary AML allowed - No CNS leukemia PATIENT CHARACTERISTICS: Age - Over 60 Performance status - ECOG 0-3 Life expectancy - Not specified Hematopoietic - See Disease Characteristics Hepatic - Bilirubin no greater than 3 mg/dL Renal - Creatinine less than 2 mg/dL Cardiovascular - Ejection fraction at least 45% by MUGA or 2-dimensional echocardiogram Other - No other malignancy for which patient is concurrently receiving treatment - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - No other concurrent colony-stimulating factors (e.g., epoetin alfa) Chemotherapy - No prior chemotherapy for AML except hydroxyurea Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LarryCripe, Study Chair, Indiana University Cancer Center
Pretoria Academic Hospital *Recruiting*
Pretoria, , 0001
South Africa
Recruiting Coenraad Slabber 27-12-354-1054
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Al Benson 312-695-1382
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62526
United States
Recruiting James Wade 217-876-6617
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-0001
United States
Recruiting James Stewart 608-265-8131
CCOP - Northern New Jersey *Recruiting*
Hackensack, New Jersey, 07601
United States
Recruiting Richard Rosenbluth 201-996-5917
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Patrick Loehrer 317-278-7418
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Suresh Nair 570-271-6413
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting John Erban 617-636-5147
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Thomas Habermann 507-284-2511
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting Witold Rybka 717-531-1050
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Howard Hochster 212-652-1912
MetroHealth Medical Center *Recruiting*
Cleveland, Ohio, 44106-5055
United States
Recruiting Brenda Cooper 216-844-3213
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Daniel Haller 215-662-6318
CCOP - Wichita *Recruiting*
Wichita, Kansas, 67214-3882
United States
Recruiting Shaker Dakhil 316-268-5784
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
MBCCOP-Our Lady of Mercy Cancer Center *Recruiting*
Bronx, New York, 10466
United States
Recruiting Peter Wiernik 718-920-1100
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
CCOP - Oklahoma *Recruiting*
Tulsa, Oklahoma, 74136
United States
Recruiting James Lockhart 918-491-5878
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Joseph Sparano 718-904-2555
Additional Information:
Study ID Numbers: CDR0000257122; ECOG-3999
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00046930
Other Myelodysplastic Syndromes Studies:
1. Daunorubicin and Cytarabine With or Without Zosuquidar Trihydrochloride in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia
2. Efficacy and safety study of CC-5013 monotherapy in subjects with myelodysplastic syndromes
3. Interleukin-2 in Treating Patients With Myelodysplastic Syndrome
4. Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
5. Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome
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Daunorubicin and Cytarabine With or Without Zosuquidar Trihydrochloride in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia
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