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Home > "D" Clinical Trials Conditions > Decitabine in Treating Children With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia  Decitabine in Treating Children With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
Decitabine in Treating Children With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
For Condition: recurrent childhood acute myeloid leukemia,secondary acute myeloid leukemia,childhood acute myeloblastic leukemia with maturation (M2),recurrent childhood acute lymphoblastic leukemia,childhood acute promyelocytic leukemia (M3)
Status: Recruiting
Sponsor(s): Children's 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. PURPOSE: Phase I trial to study the effectiveness of decitabine in treating children who have relapsed or refractoryacute myeloid leukemia or acute lymphoblastic leukemia.
Details: OBJECTIVES: - Determine the maximum tolerated dose of decitabine that is associated with consistent evidence of deoxyribonucleic acid (DNA) demethylation in children with relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia. - Determine the dose-limiting toxicity, pharmacokinetics, and antitumor activity of this drug in these patients. - Determine the biologic correlates of decitabine-induced DNA demethylation by characterizing, before and after treatment, global and specific DNA methylation status (using methylation microarrays) and hemoglobin F levels in these patients. - Determine the biologic correlates of decitabine-induced DNA demethylation by characterizing, before and after treatment, global changes in gene expression profiles using cDNA microarrays and drug sensitivity of blast cells by MTT assays in these patients. - Determine the biologic correlates of decitabine-induced DNA demethylation by characterizing, before and after treatment, deletions and single nucleotide polymorphisms in genomic DNA of deoxycytidine kinase and cytidine deaminase genes in these patients. - Determine the biologic correlates of decitabine-induced DNA demethylation by characterizing, before and after treatment, acetylation and methylation of histones H3 and H4 and helicase protein expression in these patients. OUTLINE: This is a dose-escalation, multicenter study. Patients are stratified according to disease type (acute myeloid leukemia vs acute lymphoblastic leukemia). Patients receive decitabine IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 4-6 weeks for a minimum of 4 courses 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 at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A total of 15-21 patients will be accrued for this study within 7.5-21 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed acute myeloid leukemia (AML) or acute lymphoblastic leukemia that is considered refractory to conventional therapy or for which no conventional therapy exists - For patients with AML: - M3 marrow OR - M2 marrow with at least 15% blasts - Secondary AML allowed - CNS involvement allowed PATIENT CHARACTERISTICS: Age - Under 22 Performance status - Karnofsky 50-100% (age 17 to 21) - Lansky 50-100% (age 16 and under) Life expectancy - At least 8 weeks Hematopoietic - See Chemotherapy - WBC no greater than 30,000/mm^3 - Patients with granulocytopenia, anemia, and/or thrombocytopenia are eligible but are not evaluable for hematological toxicity Hepatic - Bilirubin no greater than 1.5 times normal - ALT no greater than 5 times normal - Albumin at least 2 g/dL Renal - Creatinine no greater than 1.5 times normal OR - Creatinine clearance or radioisotope glomerular filtration rate at least lower limit of normal Cardiovascular - Shortening fraction at least 27% by echocardiogram OR - Ejection fraction at least 50% by MUGA scan Pulmonary - No evidence of dyspnea at rest - No exercise intolerance - Oxygen saturation greater than 94% by pulse oximetry Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Concurrent seizure disorder allowed if well controlled on anticonvulsants - No grade 2 or greater CNS toxicity - No uncontrolled infection (i.e., infections associated with fever, dissemination, hemodynamic instability [requiring pressor support], and progression while on therapy) - No active graft-versus-host disease (GVHD) - GVHD well controlled on cyclosporine allowed PRIOR CONCURRENT THERAPY: Biologic therapy - Recovered from prior immunotherapy - At least 1 week since prior biologic agents - At least 6 months since prior allogeneic bone marrow transplantation (BMT) - At least 3 months since prior autologous BMT - No concurrent sargramostim (GM-CSF) - No concurrent prophylactic filgrastim (G-CSF) during the first course of therapy Chemotherapy - Recovered from prior chemotherapy - At least 4 weeks since prior cytarabine - At least 24 hours since prior cytoreductive therapy with hydroxyurea (20-30 mg/kg/day for no more than 7 days) to lower the WBC to no greater than 30,000/mm^3 - No concurrent intrathecal therapy during the first course of decitabine Endocrine therapy - Not specified Radiotherapy - Recovered from prior radiotherapy - At least 2 weeks since prior local palliative radiotherapy (small port) - At least 6 weeks since prior cranial or craniospinal radiotherapy Surgery - Not specified Other - No concurrent medications that induce cytidine deaminase or deoxycytidine kinase (e.g., cytarabine) - No concurrent medications that mask poor or deteriorating organ function - No concurrent CNS prophylaxis during the first course of decitabine - Concurrent anticonvulsants with no known interactions with decitabine allowed - Concurrent antibacterial or antifungal therapies for controlled infections allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
NormanLacayo, Study Chair, Stanford University
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Brenda Weigel 612-626-8484
Children's Hospital and Regional Medical Center - Seattle *Recruiting*
Seattle, Washington, 98105
United States
Recruiting John Holcenberg 206-987-2106
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9063
United States
Recruiting Naomi Winick 214-648-3074
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting James Croop 317-278-4822
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Hopital Sainte Justine *Recruiting*
Montreal, Quebec, H3T 1C5
Canada
Recruiting Mark Bernstein 514-345-4969
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Cincinnati Children's Hospital Medical Center *Recruiting*
Cincinnati, Ohio, 45229-2899
United States
Recruiting Robert Wells 513-636-4200
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Carola Arndt 507-284-4822
Doernbecher Children's Hospital at Oregon Health & Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting H. Nicholson 503-494-1543
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Holcombe Grier 617-632-3971
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
St. Jude Children's Research Hospital *Recruiting*
Memphis, Tennessee, 38105-2794
United States
Recruiting Wayne Furman 901-495-3300
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010-2916
United States
Recruiting Anne Angiolillo 202-884-2800
University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Ronald Dubowy 315-464-5294
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Mitchell Cairo 212-305-8316
Lucile Packard Children's Hospital at Stanford University Medical Center *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Gary Houten Dahl 650-497-8238
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting Dale Pullen 601-984-5220
Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Regina Jakacki 412-692-5055
MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Jill Gilbert 504-568-5136
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104-4318
United States
Recruiting Peter Adamson 215-590-5448
Texas Children's Cancer Center *Recruiting*
Houston, Texas, 77030-2399
United States
Recruiting Susan Blaney 832-822-4215
Hospital for Sick Children *Recruiting*
Toronto, Ontario, M5G 1X8
Canada
Recruiting Sylvain Baruchel 416-813-7795
Children's Hospital Los Angeles *Recruiting*
Los Angeles, California, 90027-0700
United States
Recruiting Paul Gaynon 323-669-2163
Additional Information:
Study ID Numbers: CDR0000069471; COG-ADVL0114
Study Start Date:
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042796
Other Childhood Acute Myeloblastic Leukemia With Maturation (m2) Studies:
1. Temozolomide in Treating Young Patients With Refractory or Recurrent Leukemia
2. Bortezomib in Treating Young Patients With Refractory or Recurrent Leukemia
3. Decitabine in Treating Children With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
4. BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia
5. Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors
Related Studies:
Other childhood acute myeloblastic leukemia with maturation (M2) Clinical Trials
Other New York Clinical Trials
Other Syracuse Clinical Trials
Decitabine in Treating Children With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
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