Fludarabine/Carboplatin/Topotecan w/Thalidomide for Relapsed/Refractory AML, CML and MDS
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|ClinicalTrials.gov Identifier: NCT00053287|
Recruitment Status : Completed
First Posted : January 28, 2003
Last Update Posted : June 10, 2010
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. Combining chemotherapy with thalidomide may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining fludarabine, carboplatin, and topotecan with thalidomide in treating patients who have relapsed or refractory acute myeloid leukemia, chronic myelogenous leukemia, or advanced myelodysplastic syndromes.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases||Drug: carboplatin Drug: fludarabine phosphate Drug: thalidomide Drug: topotecan hydrochloride||Phase 2|
- Determine the response rate of patients with relapsed/refractory or high-risk acute myeloid leukemia, chronic myelogenous leukemia, or advanced myelodysplastic syndromes treated with fludarabine, carboplatin, topotecan, and thalidomide.
- Determine the non-hematologic toxicity profile and time to hematopoietic recovery in patients treated with this regimen.
- Determine the effects of this regimen on changes in biologic parameters that may predict response in these patients.
- Correlate bone marrow microvascular density before and after treatment with response in these patients.
- Determine the prognostic value of pretreatment plasma and serum levels of vascular endothelial growth factor (VEGF) and/or the modulation of serum levels of VEGF during treatment in predicting response in these patients.
OUTLINE: Patients are stratified according to diagnosis (previously untreated acute leukemia vs other).
Patients receive fludarabine IV over 5-10 minutes and carboplatin IV over 24 hours on days 1-5 followed by topotecan IV continuously over 72 hours. Patients receive oral thalidomide daily beginning within days 1-3 and continuing in the absence of disease progression or unacceptable toxicity.
Patients with residual disease on day 16-18 may receive a second course of chemotherapy as above. Patients who achieve remission may receive a third course of chemotherapy as above as consolidation beginning 4-8 weeks after completion of prior chemotherapy.
Patients are followed monthly for 6 months.
PROJECTED ACCRUAL: A total of 40 patients (20 per stratum) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Fludarabine, Carboplatin, and Topotecan With Thalidomide for Patients With Relapsed/Refractory or High Risk Acute Myelogenous Leukemia, Chronic Myeloid Leukemia and Advanced Myelodysplastic Syndromes|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||March 2007|
- Drug: carboplatin
Carboplatin IV over 24 hours on days 1-5
- Drug: fludarabine phosphate
Fludarabine IV over 5-10 minutes on days 1-5.
- Drug: thalidomide
Oral thalidomide daily beginning within days 1-3 and continuing in the absence of disease progression or unacceptable toxicity.
- Drug: topotecan hydrochloride
Topotecan IV continuously over 72 hours.
- Complete response rate [ Time Frame: 6 weeks after treatment ]
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): NCT00053287
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Study Chair:||Brenda W. Cooper, MD||Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|