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Phase III Trial of decitabine versus supportive care in adults with advanced-stage MDS Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Phase III Trial of decitabine versus supportive care in adults with advanced-stage MDS conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Phase III Trial of decitabine versus supportive care in adults with advanced-stage MDS Clinical research trials and Phase III Trial of decitabine versus supportive care in adults with advanced-stage MDS healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Phase III Trial of decitabine versus supportive care in adults with advanced-stage MDS. Phase III Trial of decitabine versus supportive care in adults with advanced-stage MDS Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Phase III Trial of decitabine versus supportive care in adults with advanced-stage MDS clinical trial. Human subjects often receive the most effective healthcare possible for their Phase III Trial of decitabine versus supportive care in adults with advanced-stage MDS condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Phase III Trial of decitabine versus supportive care in adults with advanced-stage MDS  Phase III Trial of decitabine versus supportive care in adults with advanced-stage MDS
Phase III Trial of decitabine versus supportive care in adults with advanced-stage MDS
For Condition: Myelodysplastic Syndrome
Status: Recruiting
Sponsor(s): SuperGen ,
Synopsis: To compare the safety and efficacy profiles of decitabine to those of supportive care in adults with advanced-stage myelodysplastic syndrome (MDS)
Details: This experimental (investigational) study is intended to answer the question of whether decitabine is any better than supportive care alone in delaying progression (worsening) of the disease, prolonging survival or improving the overall quality of life for MDS patients who are not candidates for BMT.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion: - MDS (de novo or secondary) fitting any of the recognized FAB classifications or CMML with WBC < 12,000/mm3, AND IPSS >/= 0.5 as determined by CBC, bone marrow assessment and bone marrow cytogenetics within 30 days of randomization - 18 years or older - Female patients of child-bearing potential must have a negative serum hCG within 24 hours prior to randomization, must practice a medically approved method of birth control for the past 30 days, and agree to continue this practice for the trial duration and must not be breast-feeding - ECOG or WHO performance status of 0-2 - Written informed consent - Normal renal and hepatic function (creatinine /=30% bone marrow blasts) or other progressive malignant disease - Patients must have recovered from the toxic effects of prior therapy and must be off all chemotherapy for a minimum of 4 weeks prior to study entry to the protocol (a minimum of six weeks for prior nitrosoureas and bone marrow transplantation) - Ongoing treatment with androgenic hormones, danazol, colony-stimulating factors, or other agents used to treat MDS within 7 days of study initiation. - Administration of any investigational agent within the 30 days preceding study initiation. - Uncontrolled cardiac disease or congestive heart failure - Uncontrolled restrictive or obstructive pulmonary disease - Active viral or bacterial infection - Superimposed autoimmune hemolytic anemia or thrombocytopenia - Known positive serology for HIV - Mental illness or other condition preventing full cooperation with the treatment and monitoring requirements of the study.
Total Enrollment: 160
Location and Contact Information:
MD Anderson Cancer Center *Recruiting*
Houston, Texas,
United States
Recruiting Jean-Pierre Issa
Univ. California San Francisco Medical School *Recruiting*
San Francisco, California,
United States
Recruiting Thomas Martin
Roswell Park Cancer Institute *Recruiting*
Buffalo, New York,
United States
Recruiting James Slack
University of Massachusetts Medical School *Recruiting*
Worcester, Massachusetts,
United States
Recruiting Peter Westervelt
Rush Medical Center *Recruiting*
Chicago, Illinois,
United States
Recruiting Azra Raza
UNC Lineberger Comprehensive Cancer Center *Recruiting*
Chapel Hill, North Carolina,
United States
Recruiting Beverly Mitchell
VA Medical Center *Recruiting*
Minneapolis, Minnesota,
United States
Recruiting Pankaj Gupta
Texas Oncology *Recruiting*
Dallas, Texas,
United States
Recruiting Craig Rosenfeld
Alta Bates Comprehensive Cancer Center *Terminated*
Berkeley, California,
United States
Terminated
H. Lee Moffitt Cancer Center *Recruiting*
Tampa, Florida,
United States
Recruiting Hussain Saba
Scripps Clinic *Recruiting*
Escondido, California,
United States
Recruiting Richard Just
Loma Linda Univ. Cancer Center *Recruiting*
Loma Linda, California,
United States
Recruiting Chien-Shing Chang
City of Hope National Medical Center *Recruiting*
Duarte, California,
United States
Recruiting Margaret O'Donnell
University of Illinois at Chicago *Recruiting*
Chicago, Illinois,
United States
Recruiting Farhad Ravandi
New England Medical Center Hospital *Recruiting*
Boston, Massachusetts,
United States
Recruiting Kenneth Miller
James A. Haley Veteran's Hospital *Recruiting*
Tampa, Florida,
United States
Recruiting Hussain Saba
Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts,
United States
Recruiting Daniel DeAngelo
Washington Univ. School of Medicine *Recruiting*
St. Louis, Missouri,
United States
Recruiting John DiPersio
Duke University Medical Center *Recruiting*
Durham, North Carolina,
United States
Recruiting Carlos deCastro
SW Regional Cancer Center (dba Central Texas Oncology Associates) *Recruiting*
Austin, Texas,
United States
Recruiting Richard Helmer
Memorial Sloan Kettering Cancer Center *Recruiting*
New York City, New York,
United States
Recruiting Virginia Klimek
Mount Sinai Medical Center *Recruiting*
New York City, New York,
United States
Recruiting Louis Silverman
University of Florida *Recruiting*
Gainesville, Florida,
United States
Recruiting Kataryzna Finiewicz
The Memphis Cancer Center *Recruiting*
Memphis, Tennessee,
United States
Recruiting Donald Strickland
Additional Information:
Study ID Numbers: D-0007;
Study Start Date: April 2001
Record last reviewed: August 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00043381
Other Myelodysplastic Syndrome Studies:
1. Phase II Randomized Study of three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS)
2. Antithymocyte Globulin and Cyclosporine to Treat Myelodysplasia
3. Specialized Blood Cell Transplants for Cancers of the Blood and Bone Marrow
4. Clofarabine combinations in relapsed/refractory AML, MDS and myeloid blast phase CML
5. Study to Determine the Safety and Preliminary Efficacy of CC-1088 in the Treatment of Myelodysplastic Syndromes
Related Studies:
Other Myelodysplastic Syndrome Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Phase III Trial of decitabine versus supportive care in adults with advanced-stage MDS
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