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Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Clinical research trials and Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia. Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia clinical trial. Subjects typically recieve the finest healthcare available for their Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia  Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
For Condition: atypical chronic myeloid leukemia,secondary acute myeloid leukemia,untreated adult acute myeloid leukemia,myelodysplastic and myeloproliferative disease,Myelodysplastic Syndromes,adult acute myeloid leukemia
Status: Recruiting
Sponsor(s): Princess Margaret Hospital , 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. PURPOSE: Phase I trial to study the effectiveness of decitabine in treating patients who have myelodysplastic syndrome or acute myeloid leukemia.
Details: OBJECTIVES: - Determine the maximum tolerated dose of decitabine in patients with high-risk myelodysplastic syndromes or acute myeloid leukemia. - Determine the minimum effective dose of this drug that produces demethylation of DNA with tolerable toxicity in these patients. - Determine the minimum effective dose of this drug that augments in vitro responses to retinoids. - Determine the pharmacokinetics of this drug in these patients. - Determine the clinical response rate of patients treated with this drug. OUTLINE: This is a dose-escalation, multicenter study. Patients receive decitabine IV over 3 hours every 12 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of decitabine 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. PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - One of the following diagnoses: - High-risk myelodysplastic syndromes (MDS) - Acute myeloid leukemia (AML) - De novo, secondary, or relapsed disease - Any number of prior regimens for primary or relapsed disease - Ineligible for or refuses aggressive management - Measurable disease defined as: - More than 5% blasts in bone marrow of patients with MDS - More than 30% blasts in bone marrow of patients with AML - Involvement of cerebrospinal fluid allowed PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - Not specified Hematopoietic - See Disease Characteristics Hepatic - Bilirubin no greater than 1.25 times upper limit of normal (ULN) - AST and/or ALT no greater than 1.25 times ULN Renal - Creatinine less than 1.7 mg/dL OR - Creatinine clearance at least 60 mL/min Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - No ongoing or active infection - No other uncontrolled concurrent illness that would preclude study participation - No psychiatric illness or social situation that would preclude study compliance - No prior allergic reactions to compounds of similar chemical or biological composition to decitabine - No other active malignancy - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - At least 4 weeks since prior biologic therapy (e.g., interferon, filgrastim [G-CSF], sargramostim [GM-CSF], thrombopoietin, or epoetin alfa) - No concurrent hematopoietic growth factors (GM-CSF, thrombopoietin, or epoetin alfa) - No concurrent prophylactic G-CSF Chemotherapy - Prior intrathecal cytarabine allowed for patients with cerebrospinal fluid involvement - At least 4 weeks since prior chemotherapy (except low-dose chemotherapy administered to maintain WBC counts) (6 weeks for nitrosoureas or mitomycin) and recovered - At least 24 hours since prior hydroxyurea - Concurrent intrathecal cytarabine allowed for patients with cerebrospinal fluid involvement Endocrine therapy - Not specified Radiotherapy - No prior radiotherapy greater than 3,000 cGy to marrow-producing areas - At least 4 weeks since prior radiotherapy and recovered Surgery - Not specified Other - Prior investigational therapy allowed - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients - No concurrent commercial or other investigational anticancer therapies or agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MarkMinden, Study Chair, Princess Margaret Hospital
McMaster Children's Hospital at Hamilton Health Sciences *Recruiting*
Hamilton, Ontario, L8N 3Z5
Canada
Recruiting Brian Leber 905-521-2100 Ext. 76384
Cancer Care Ontario-London Regional Cancer Centre *Recruiting*
London, Ontario, N6A 4L6
Canada
Recruiting Michael Kovacs 519-685-8500, ext. 55182
Margaret and Charles Juravinski Cancer Centre *Recruiting*
Hamilton, Ontario, L8V 5C2
Canada
Recruiting Deborah Marcellus 905-575-9827
Princess Margaret Hospital *Recruiting*
Toronto, Ontario, M5G 2M9
Canada
Recruiting Mark Minden 416-946-2015
Additional Information:
Study ID Numbers: CDR0000258121; NCI-5591,PMH-PHL-004
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00049582
Other Adult Acute Myeloid Leukemia Studies:
1. Biological Therapy in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation
2. Oblimersen, Cytarabine, and Daunorubicin in Treating Older Patients With Acute Myeloid Leukemia
3. Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
4. FR901228 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
5. Flavopiridol, Cytarabine, and Mitoxantrone in Treating Patients With Acute Leukemia
Related Studies:
Other adult acute myeloid leukemia Clinical Trials
Other Ontario Clinical Trials
Other Hamilton Clinical Trials
Decitabine in Treating Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
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