Status:
TERMINATED
Study of Velcade and Thalidomide in Patients With Myelodysplasia
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to find out what the maximal tolerated dose of Velcade can be given with thalidomide in patients with myelodysplasia.
Detailed Description
Initial studies using Velcade in myelodysplasia with early results demonstrating that 35% had a partial response and 25% had stable disease. The combination of Velcade and thalidomide has been studied...
Eligibility Criteria
Inclusion
- Myelodysplastic syndrome with a IPSS score of 0.5 or greater
- May have had prior chemo/radiotherapy for another malignancy or myelodysplasia
- ECOG performance status of 0-2
- Life expectancy greater than 3 months
- Total bilirubin \</+ 2xULN
- ALT and AST \</+ 3xULN
- Calculated creatinine clearance \> 30 ml/min
- Use of appropriate method of contraception during the study
- ANC \> 0.5 x 10(9)
- Platelet count \> 30 x 10(9)
- Consideration of treatment with 5 azacytidine is encouraged by not required
Exclusion
- Ejection fraction \< 40%
- myocardial infarction within 6 months of enrollment of New York Heart Association Class III or IV heart failure, uncontrolled angina, uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Women who are pregnant or breast-feeding
- Major surgery within 4 weeks prior to enrollment
- \>/= grade 2 peripheral neuropathy within 14 days prior to enrollment
- Uncontrolled intercurrent illness
- Serious medical or psychiatric illness that could potentially interfere with the completion of treatment
- Hypersensitivity to bortezomib, boron, or mannitol
- Received an investigational drug within 14 days of enrollment
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2007
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00271804
Start Date
June 1 2005
End Date
April 1 2007
Last Update
March 13 2008
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115