NCT00818649

Bortezomib and Vorinostat in Treating Patients With High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia

Phase II Trial of Velcade Plus Vorinostat in the Treatment of High Risk MDS and Relapsed/Refractory AML

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Bortezomib and vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving bortezomib together with vorinostat may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving bortezomib together with vorinostat works in treating patients with high-risk myelodysplastic syndrome or acute myelogenous leukemia.

Detailed description

OBJECTIVES: Primary * To determine the clinical response to bortezomib and vorinostat in patients with high-risk myelodysplastic syndromes or acute myeloid leukemia, as defined by the International Working Group response criteria. Secondary * To characterize the quantitative and qualitative toxicities of this regimen in these patients. * To assess the effect of this regimen on natural killer (NK) cell function, in terms of activating and inhibitory receptor alterations, target cell ligand and HLA class I modulation, and NK-mediated cell killing. * To correlate the above changes with clinical response. OUTLINE: Patients receive bortezomib subcutaneously (SQ) on days 1, 4, 8, and 11 and oral vorinostat once daily on days 1-14. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response, partial response, or hematologic improvement may receive 3 additional courses of therapy (for a maximum of 6 courses). Bone marrow and peripheral blood samples are collected at baseline and at the completion of 3 courses of therapy for analysis of target cells (myeloid blasts) (i.e., HLA class I receptor analysis and natural killer \[NK\] cell receptor ligand analysis) and analysis of activating NK cell receptor alterations and NK-mediated cell killing. After completion of study treatment, patients are followed periodically for up to 1 year.

Conditions

• Leukemia
• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	bortezomib	1.3mg/m\^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle
DRUG	vorinostat	400 mg orally (po) every day on days 1-14 of a 21 day cycle

Timeline

• Start date: 2009-01-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2009-01-08
• Last updated: 2017-12-28
• Results posted: 2013-02-25

Locations

1 site across 1 country: United States