Combination Chemotherapy in Treating Patients With Myelodysplastic Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00003827|
Recruitment Status : Unknown
Verified July 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : September 25, 2003
Last Update Posted : December 4, 2013
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of combining topotecan and cytarabine given with amifostine in treating patients who have myelodysplastic syndrome.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes||Drug: amifostine trihydrate Drug: cytarabine Drug: topotecan hydrochloride||Phase 2|
- Determine the toxic effects of amifostine, topotecan, and cytarabine in patients with poor risk myelodysplastic syndrome.
- Determine the hematologic response rate, cytogenetic response rate, and the rate of polyclonal hematopoiesis following this treatment regimen.
- Determine the duration of response and time to disease progression following this treatment regimen in these patients.
OUTLINE: Patients receive topotecan by continuous IV over 24 hours plus cytarabine IV over 2 hours, on days 1-5. Patients receive amifostine IV over 15 minutes every other day for a maximum of 60 days. Patients may receive a second course of the same regimen 8 weeks after the first.
Patients are followed at least monthly for 2 years, then every 3-6 months until death.
PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study within 1 to 1.5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Official Title:||Treatment of Poor Risk Myelodysplasia With the Combination of Amifostine, Topotecan and ARA-C: A Phase II Study|
|Study Start Date :||January 1999|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003827
|United States, California|
|Cancer Center and Beckman Research Institute, City of Hope|
|Duarte, California, United States, 91010-3000|
|Study Chair:||Henry C. Fung, MD, FRCPE||City of Hope Comprehensive Cancer Center|