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Oblimersen, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia 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 Oblimersen, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Oblimersen, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia Clinical research trials and Oblimersen, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia 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 Oblimersen, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia. Oblimersen, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia 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 Oblimersen, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia clinical trial. Human subjects often get the best healthcare possible for their Oblimersen, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia 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 > "O" Clinical Trials Conditions > Oblimersen, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia  Oblimersen, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia
Oblimersen, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia
For Condition: untreated adult acute myeloid leukemia,secondary acute myeloid leukemia
Status: Recruiting
Sponsor(s): Arthur G. James Cancer Hospital & Richard J. Solove 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. Oblimersen may help cytarabine and daunorubicin kill more cancer cells by making them more sensitive to chemotherapy. PURPOSE: Phase I trial to study the effectiveness of combining oblimersen with cytarabine and daunorubicin in treating older patients who have previously untreated acute myeloid leukemia.
Details: OBJECTIVES: - Determine the maximum tolerated dose of daunorubicin in combination with cytarabine and oblimersen in older patients with previously untreated acute myeloid leukemia. - Determine the qualitative and quantitative toxic effects of this regimen in these patients. - Determine the pharmacokinetics of oblimersen in this regimen in these patients. - Determine the disease-free survival and overall survival of patients treated with this regimen. - Assess the spontaneous rate of apoptosis in leukemic blasts in patients before and after initiation of treatment with oblimersen. - Determine therapeutic response (complete remission) in patients treated with this regimen. OUTLINE: This is a dose-escalation study of daunorubicin. Patients are stratified according to disease status (primary vs secondary). - Patients receive oblimersen (G3139) IV continuously on days 1-10 and cytarabine IV continuously on days 4-10. Patients also receive daunorubicin IV daily on days 4-6. Patients with bone marrow cellularity of at least 20% and at least 5% leukemic blasts at day 17 or evidence of refractory disease receive a second induction comprising G3139 IV continuously on days 1-8, cytarabine IV continuously on days 4-8, and daunorubicin IV on days 4-5. - Consolidation therapy: Beginning no sooner than 14 days after hematologic recovery from induction therapy, patients receive G3139 IV continuously on days 1-8 and cytarabine IV over 4 hours on days 4-8. Patients receive a second course of consolidation therapy no sooner than 14 days after hematologic recovery from the first course. Cohorts of 3-6 patients receive escalating doses of daunorubicin 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. Patients are followed every 2 months for 2 years. PROJECTED ACCRUAL: A total of 12-32 patients (6-16 per stratum) will be accrued for this study within 9 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 60 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed primary or secondary acute myeloid leukemia (AML) - More than 20% bone marrow blasts - Myelodysplastic syndromes (MDS) or a chronic myeloproliferative disorder antecedent to AML allowed - Therapy-related AML allowed - No acute promyelocytic leukemia PATIENT CHARACTERISTICS: Age: - 60 and over Performance status: - Not specified Life expectancy: - At least 4 weeks Hematopoietic: - Not specified Hepatic: - Bilirubin no greater than 2 mg/dL - ALT and AST no greater than 2 times upper limit of normal (unless directly attributable to AML) Renal: - Creatinine no greater than 2.5 mg/dL Cardiovascular: - Ejection fraction at least 50% by MUGA or echocardiogram - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other: - No allergy to any of the study medications - No other uncontrolled concurrent illness - No serious medical or psychiatric illness that would preclude giving informed consent - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior therapy for primary AML except emergency leukapheresis Chemotherapy: - No prior anthracyclines - No prior chemotherapy for primary AML except hydroxyurea for hyperleukocytosis - At least 3 months since prior chemotherapy for MDS or chronic myeloproliferative disorders antecedent to AML - No other concurrent chemotherapy Endocrine therapy: - No concurrent corticosteroids as anti-emetics - No concurrent steroids except for adrenal failure or septic shock - No concurrent hormonal therapy except hormones for non-disease-related conditions (e.g., insulin for diabetes, tamoxifen or equivalent for breast cancer prevention or adjuvant treatment, or estrogens or progestins for gynecologic indications) Radiotherapy: - No prior radiotherapy for primary AML except cranial radiotherapy for CNS leukostasis - No concurrent palliative radiotherapy - No concurrent whole brain radiotherapy Surgery: - Not specified Other: - No other concurrent investigational or commercial agents or therapies - No concurrent cyclooxygenase-2 inhibitors
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GuidoMarcucci, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Wendy Stock 773-834-8982
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Guido Marcucci 614-293-7597
Additional Information:
Study ID Numbers: CDR0000069353; OSU-0164,NCI-4630
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00039117
Other Secondary Acute Myeloid Leukemia Studies:
1. Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Acute Leukemia
2. Gemtuzumab Ozogamicin With or Without Chemotherapy in Treating Older Patients With Acute Myeloid Leukemia
3. Combination Chemotherapy Plus PSC 833 Followed by Interleukin-2 in Treating Older Patients With Acute Myeloid Leukemia
4. Combination Chemotherapy With or Without G-CSF in Treating Older Patients With Acute Myeloid Leukemia
5. Arsenic Trioxide in Treating Patients With Acute Myeloid Leukemia
Related Studies:
Other secondary acute myeloid leukemia Clinical Trials
Other Illinois Clinical Trials
Other Chicago Clinical Trials
Oblimersen, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia
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