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Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes Clinical research trials and Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes healthcare trials happen in many of places across 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 effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes. Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes  Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes
Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes
For Condition: Leukemia,Myelodysplastic Syndromes
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , SuperGen
Synopsis: Valproic acid is a medication that is currently used in the prevention of seizures, bipolar disorder, and migraine headaches. Researchers hope that it may improve the effects of decitabine. Decitabine is a chemotherapy drug with known activity in leukemia and myelodysplastic syndromes.
Details: Recent studies have shown synergy between demethylating agents and histone deacetylase inhibitors. It has been shown that both DNA methylation and histone deacetylation work together in affecting gene expression. Therefore, drugs that inhibit DNA methylation and those that inhibit histone deacetylase can reactivate silenced genes in combination better than they can individually. Decitabine (5 aza-2'deoxycytidine), a drug that produces marked DNA hypomethylator, has demonstrated antileukemic activity at low doses. There are several drugs that have been shown to have histone acetylase activity. One of these is valproic acid that has been used safely for many years as an anti-seizure medication.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 2 Years/
Genders: Both
Protocol Entry Criteria: Inclusion: - Patients with refractory or relapsed: acute myelogenous leukemia (AML), acute lymphocytic leukemia (ALL), and myelodysplastic syndrome (MDS) are eligible. Patients with chronic lymphocytic leukemia (CLL) are eligible if fludarabine based therapy has failed. Patients with chronic myeloid leukemia (CML) are eligible if they have documented hematologic resistance to imatinib mesylate or have not achieved or lost any cytogenetic response to imatinib mesylate after 12 months of therapy. - Untreated patients older than 60 years of age with AML or MDS who refuse or are not eligible for frontline chemotherapy, are eligible. - Performance status of < 2 by the ECOG scale. - Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of UTMDACC. - Age > 2 years. Valproic acid has been associated with a higher rate of severe liver toxicity in children younger than 2 years. - Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease. Use of hydroxyurea for patients with rapidly proliferative disease is allowed for the first two weeks on therapy. Imatinib mesylate (Gleevec) and anagrelide must also be stopped 2 weeks prior to entering this study. - Adequate liver function (bilirubin of < 2mg%, SGPT 3 x ULN) and renal function (creatinine < 2mg%). - Women of childbearing potential must practice contraception. Men and women must continue birth control for the duration of the trial. Exclusion: - Nursing and pregnant females are excluded. - Patients with active and uncontrolled infections are excluded. - Patients with a known ornithine transcarbamylase disorder, history of unexplained coma, or a family history of ornithine transcarbamylase disorder are excluded from this study. - Uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, pancreatitis, psychiatric illness that would limit compliance with study requirements. - Patients with history of hepatitis B, C, alcoholic liver disease or evidence of hepatopathy will be excluded. - Patients already receiving valproic acid or receiving other anticonvulsionants will be excluded. - Untreated patients younger than 60 years will not be candidates for this study.
Total Enrollment: 60
Location and Contact Information:
M.D. Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Guillermo Garcia-Manero 713-745-3428
Additional Information:
Study ID Numbers: 2003-0314;
Study Start Date: January 2004
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075010
Other Myelodysplastic Syndromes Studies:
1. A study to access the safety/efficacy of thalidomide in the treatment of anemia in patients with Myelodysplastic Syndromes
2. Monoclonal Antibody, Cyclophosphamide, and Radiation Therapy Followed by Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome
3. HLA-Mismatched Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematological Malignancies
4. Biological Therapy in Treating Patients With Myelodysplastic Syndrome
5. Phenylbutyrate and Tretinoin in Treating Patients With Hematologic Cancer
Related Studies:
Other Myelodysplastic Syndromes Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Phase I/II Study of Decitabine and Valproic Acid in Relapsed/Refractory Leukemia or Myelodysplastic Syndromes
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