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Phase II Randomized Study of three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS) Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Phase II Randomized Study of three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS) conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Phase II Randomized Study of three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS) Clinical research trials and Phase II Randomized Study of three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS) medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Phase II Randomized Study of three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS). Phase II Randomized Study of three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS) Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Phase II Randomized Study of three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS) clinical trial. Participants frequently obtain the most expert healthcare available for their Phase II Randomized Study of three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS) condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase II Randomized Study of three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS)  Phase II Randomized Study of three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS)
Phase II Randomized Study of three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS)
For Condition: Myelodysplastic Syndrome,Chronic Myelomonocytic Leukemia
Status: Recruiting
Sponsor(s): M.D. Anderson Cancer Center , SuperGen
Synopsis: Methylation is a change that occurs to DNA that has an effect on gene usage in human cells. Abnormal methylation is very common in leukemias. Decitabine is a new drug that blocks DNA methylation. The goal of this clinical research study is learn if decitabine (given at 3 different doses) can help to control MDS. The safety of these 3 treatments will also be studied.
Details: Since decitabine is effective in MDS, we would like to continue investigating its activity, correlate methylation profiles with response, and improve on the efficacy: toxicity profile of the regimen. Preclinical studies indicate that longer exposure to decitabine is more active since the drug has to integrate into one, then the second DNA strand, before inducing the full hypomethylating effect. Therefore, an exposure of > 5 days (rather than the 3-day schedule used in MDS by Wijermans et al) may be better. On the other hand, it is yet unknown whether a longer exposure (10 days versus 5 days) would be clinically even more effective,and whether it would have more side-effects if the total dose of decitabine per course is the same. A subcutaneous decitabine schedule in MDS will also have multiple advantages (quality of life, less catheter-related infections, less hospital environment) in addition to possible better pharmacokinetic profile and better efficacy. We thus propose to investigate, in a phase II randomized study, the comparative efficacy and toxicity of three different schedules of decitabine which deliver the same total dose of the drug per course: 1) decitabine 10 mg/m2 IV over 1 hour daily x 10; versus 2) decitabine 20 mg/m2 IV over 1 hour daily x 5 (total 100 mg/m2 per course); versus 3) decitabine 10 mg/m2 SQ BID x 5 days (20 mg/m2/day x 5 = 100 mg/m2 per course).
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Eligibility Criteria: - Patients with MDS and > 5% blasts or IPSS risk intermediate or high; patients with CMML. No prior intensive chemotherapy or high-dose ara-C (> 1g/m2). Prior biologic therapies, targeted therapies, or single agent chemotherapy allowed. 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. Hydroxyurea is permitted for control of counts prior to treatment. Procrit, GCSF are allowed before therapy. Procrit, GCSF or other growth factors are permitted on therapy. Use of hydroxyurea with rapidly proliferative disease is allowed for the first two weeks on therapy. - Performance 0-2 (ECOG). Adequate liver function (bilirubin of < 2mg/dl) and renal function (creatinine < 2mg/dl). Adequate cardiac functions (NYHA cardiac III-IV excluded) - Signed informed consent Exclusion Criteria - Nursing and pregnant females. Patients of childbearing potential should practice effective methods of contraception. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. - Active and uncontrolled infections. - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
Total Enrollment: 90
Location and Contact Information:
Overall Study Official:
HagopKantarjian, Principal Investigator, University of Texas M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030
United States
Recruiting Hagop Kantarjian 713-792-7026
Additional Information:
Study ID Numbers: ID03-0180;
Study Start Date: October 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067808
Other Myelodysplastic Syndrome Studies:
1. Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers
2. Tipifarnib in Treating Patients With Myelodysplastic Syndrome
3. Tipifarnib in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome in Complete Remission
4. Phase II Randomized Study of three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS)
5. Vaccine Therapy in Treating Patients With Myelodysplastic Syndrome
Related Studies:
Other Myelodysplastic Syndrome Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Phase II Randomized Study of three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS)
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