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Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Clinical research trials and Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds of circumstances, including Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Clinical Trials and other clinical trials allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, and sometimes they are paid for their time. Occasionally there is a cost for a Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma clinical trial. Participants typically obtain the most effective healthcare available for their Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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Home > "D" Clinical Trials Conditions > Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma  Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
For Condition: recurrent diffuse small lymphocytic/marginal zone lymphoma,untreated adult acute myeloid leukemia,recurrent adult acute myeloid leukemia,refractory chronic lymphocytic 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, such as decitabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Valproic acid may stop the growth of cancer cells by blocking the enzymes necessary for their growth. Combining decitabine with valproic acid may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combining decitabine with valproic acid in treating patients who have refractory or relapsedacute myeloid leukemia or previously-treated chronic lymphocytic leukemia or small lymphocytic leukemia.
Details: OBJECTIVES: Primary - Determine the minimally effective pharmacological dose (MEPD) of decitabine in patients with refractory or relapsed acute myeloid leukemia or with previously treated chronic lymphocytic lymphoma or small lymphocytic lymphoma. - Determine the maximum tolerated dose (MTD) of valproic acid in combination with the MEPD of decitabine in these patients. - Determine the MEPD of valproic acid in combination with decitabine in these patients. - Determine the qualitative and quantitative toxic effects of decitabine alone and in combination with valproic acid, in regard to organ specificity, time course, predictability, and reversibility in these patients. Secondary - Determine the therapeutic response of patients treated with decitabine alone and in combination with valproic acid. - Determine the pharmacokinetics of this regimen in these patients. - Correlate baseline and post-treatment changes in DNA methyltransferases (MT1, MT3a, and MT3b) expression with achievement of decitabine MEPD, toxicity, treatment resistance, and disease response in these patients. OUTLINE: This is a dose-escalation study. Patients are stratified according to disease (refractory or relapsed acute myeloid leukemia vs chronic lymphocytic leukemia or small lymphocytic lymphoma). Patients receive decitabine IV over 1 hour on days 1-10. Treatment repeats every 28 days. Cohorts of 6 patients receive escalating doses of decitabine until the minimally effective pharmacological dose (MEPD) is determined. The MEPD is defined as the dose at which at least 5 of 6 patients meet gene methylation criteria and no more than 1 of 6 patients experiences dose limiting toxicity (DLT). Once the MEPD is determined, patients receive decitabine at that dose level administered as above and oral valproic acid three times daily on days 5-21. Treatment repeats every 28 days. Cohorts of 3-6 patients receive escalating doses of valproic acid 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 DLT. The MEPD of valproic acid is then determined using established gene methylation and toxicity criteria. Treatment continues for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 84 patients (42 per stratum) will accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of one of the following as defined by the WHO classification: - Acute myeloid leukemia (AML) (Stratum I) meeting one of the following criteria: - Primary refractory or relapsed (in 1 year or less) disease and not a candidate for potentially curative therapy - Untreated (or previously treated but fulfilling criteria for poor prognosis) with poor-risk leukemia defined by any of the following criteria: - More than 65 years old - Poor-risk cytogenetics, defined as patients with karyotype abnormalities other than t(8;21), inv(16), t(15;17) - Poor candidate for aggressive chemotherapy - Chronic lymphocytic leukemia or small lymphocytic lymphoma (Stratum II) meeting the following criteria: - Received at least one prior therapy that included a purine analog* NOTE: *Patients with a history of severe autoimmune disease or requiring therapy with chronic corticosteroids or have any other specific relative contraindications to receive a purine analog may have received another form of therapy that includes alkylating agents - No granulocytic sarcoma PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-2 Life expectancy - At least 12 weeks Hematopoietic - Stratum I: - WBC 10,000/mm - (40,000/mm - if stable for the past week)* NOTE: *May be sustained with hydroxyurea before starting therapy and during the first 4 days of therapy - Stratum II: - No uncontrolled autoimmune hemolytic anemia - No idiopathic thrombocytopenia purpura Hepatic - Bilirubin 1.5 mg/dL - ALT and AST 2 times upper limit of normal Renal - Creatinine 2.0 mg/dL Other - No active infections requiring IV antibiotics - HIV negative - No other severe medical condition that would preclude study participation - No psychiatric condition that would preclude study compliance - No history of seizures - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - See Disease Characteristics - More than 14 days since prior chemotherapy (except hydroxyurea) - No prior FR901228 (depsipeptide) for step 2 of this study - No other concurrent chemotherapy Endocrine therapy - See Disease Characteristics - No concurrent corticosteroids for antiemetic therapy - No concurrent hormonal therapy except the following: - Steroids for treatment of adrenal failure or septic shock - Insulin for diabetes - Tamoxifen or equivalent for breast cancer prevention or adjuvant therapy - Estrogens or progestins for gynecologic indications Radiotherapy - More than 14 days since prior radiotherapy - No concurrent palliative radiotherapy Surgery - Not specified Other - No concurrent anticonvulsant medication, including valproic acid
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GuidoMarcucci, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
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: CDR0000355412; NCI-6236,OSU-0336,OSU-2003C0094
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00079378
Other Recurrent Adult Acute Myeloid Leukemia Studies:
1. Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, or Multiple Myeloma
2. Thalidomide in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
3. High-Dose Chemotherapy Followed by Total-Body Irradiation and Peripheral Stem Cell Transplantation in Treating Patients With Chronic Lymphocytic Leukemia
4. LMB-2 Immunotoxin in Treating Patients With Chronic Lymphocytic Leukemia
5. Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Lymphoma or Waldenstrom's Macroglobulinemia
Related Studies:
Other recurrent adult acute myeloid leukemia Clinical Trials
Other Ohio Clinical Trials
Other Columbus Clinical Trials
Decitabine and Valproic Acid in Treating Patients With Refractory or Relapsed Acute Myeloid Leukemia or Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
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