NCT00053287

Fludarabine/Carboplatin/Topotecan w/Thalidomide for Relapsed/Refractory AML, CML and MDS

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Leukemia
• Myelodysplastic Syndromes
• Myelodysplastic/Myeloproliferative Diseases

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2002-09-01
• Primary completion: 2007-01-01
• Completion: 2007-03-01
• First posted: 2003-01-28
• Last updated: 2010-06-10

Locations

1 site across 1 country: United States