A Phase 2 interventional study of carboplatin and fludarabine phosphate in Leukemia, Myelodysplastic Syndromes and Myelodysplastic/Myeloproliferative Diseases, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-06-10.
Sponsored by Case Comprehensive Cancer Center · Phase 2, Interventional, and Treatment
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.
OBJECTIVES:
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.
5,475 studies on the registry are indexed under Leukemia; 629 are open to participants now.
This study's enrollment of 42 is above the median of 38 across 4,268 interventional studies indexed under Leukemia.
Browse Leukemia studies →Case Comprehensive Cancer Center is the lead sponsor of 493 studies on the registry; 59 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 46 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Acute myeloid leukemia meeting 1 of the following criteria:
Myelodysplastic syndromes (MDS)
Must meet at least 1 of the following criteria:
Acute promyelocytic leukemia
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Carboplatin IV over 24 hours on days 1-5
Fludarabine IV over 5-10 minutes on days 1-5.
Oral thalidomide daily beginning within days 1-3 and continuing in the absence of disease progression or unacceptable toxicity.
Topotecan IV continuously over 72 hours.
Complete response rate
Time frame: 6 weeks after treatment
This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Carboplatin · Fludarabine phosphate · Thalidomide · Topotecan
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