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Combination Chemotherapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Combination Chemotherapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia Clinical research trials and Combination Chemotherapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia healthcare trials take place in many of cities 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 evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Combination Chemotherapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia. Combination Chemotherapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Combination Chemotherapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare 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 > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia  Combination Chemotherapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia
Combination Chemotherapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia
For Condition: adult acute myeloid leukemia,adult acute monocytic leukemia
Status: Recruiting
Sponsor(s): H. Lee Moffitt Cancer Center and Research Institute , 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. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy in treating patients who have previously untreated acute myeloid leukemia.
Details: OBJECTIVES: - Determine the maximum tolerated dose (MTD) of topotecan when combined with daunorubicin, cytarabine, and etoposide in patients with de novo acute myeloid leukemia. - Determine the efficacy of this regimen at the MTD of topotecan by measuring the complete response rate in this patient population. - Determine the days of hospitalization and number of infections associated with this regimen in these patients. - Correlate serum levels of topotecan and etoposide with the expression of topoisomerase I and II in tumor cells and in peripheral blood mononuclear cells (PBMN), as well as with toxicity and response rate in these patients. - Correlate tumor cell and PBMN expression and activity of topoisomerase I and II with hematological toxicity and clinical response in these patients. - Correlate levels of activation of STAT signaling proteins with expression of bcl-2 family proteins and response to chemotherapy in these patients. OUTLINE: This is a dose-escalation study of topotecan (phase I) followed by a response rate-determination (phase II) study. Patients receive induction chemotherapy with daunorubicin IV over 10-15 minutes on days 1-3, cytarabine IV continuously on days 1-5, topotecan IV continuously on days 6-8, and etoposide IV over 60 minutes on days 9 and 10. Within 4 weeks of hematologic recovery, patients achieving remission after induction receive consolidation chemotherapy with cytarabine IV over 1 hour every 12 hours on days 1, 3, and 5. Subsequent courses of consolidation chemotherapy begin within 2 weeks of documentation of hematologic recovery from the prior consolidation course. Consolidation chemotherapy continues for 4 courses in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, additional patients are accrued to receive induction chemotherapy at the recommended phase II dose. Patients are followed at 1 month, every 2 months for 1 year, every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 3-36 patients (phase I) and then an additional 24-27 patients (phase II) will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/59 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed newly diagnosed, previously untreated acute myeloid leukemia (AML) - All FAB types, M0-M7, excluding M3 - No AML after myelodysplastic syndrome PATIENT CHARACTERISTICS: Age: - 16 to 59 Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - Bilirubin less than 2 mg/dL - SGOT/SGPT normal unless due to leukemic disease - Alkaline phosphatase normal unless due to leukemic disease Renal: - Creatinine no greater than 2.0 mg/dL OR - Creatinine clearance greater than 60 mL/min Cardiovascular: - Ejection fraction at least 50% by MUGA - No myocardial infarction or serious ventricular arrhythmia within the past 6 months Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other prior malignancy within the past 5 years except resected skin cancer - HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior topotecan or any other DNA topoisomerase I inhibitor (e.g., irinotecan, aminocamptothecin, or nitrocamptothecin) or etoposide for any prior malignancy Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - Not specified
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HussainSaba, Study Chair, H. Lee Moffitt Cancer Center and Research Institute
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting Daniel Sullivan 813-979-3878
Additional Information:
Study ID Numbers: CDR0000067748; NCI-G00-1751,MCC-IRB-5367,MCC-11941
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005793
Other Adult Acute Monocytic Leukemia Studies:
1. Flavopiridol and Imatinib Mesylate in Treating Patients With Hematologic Cancer
2. Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With Advanced Myeloid Cancer
3. Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia
4. Vaccine Therapy Plus Immune Adjuvant in Treating Patients With Chronic Myeloid Leukemia, Acute Myeloid Leukemia, or Myelodysplastic Syndrome
5. Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer
Related Studies:
Other adult acute monocytic leukemia Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
Combination Chemotherapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia
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