Status:
COMPLETED
Bortezomib Plus Prednisone for Initial Therapy of Chronic Graft Versus Host Disease
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Millennium Pharmaceuticals, Inc.
Conditions:
Chronic Graft Versus Host Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this research study is to determine the effectiveness of bortezomib (Velcade) plus prednisone for treating chronic graft versus host disease (cGVHD) and the safety of this drug combinat...
Detailed Description
* Each treatment cycle lasts five weeks, during which time participants will come to the clinic to receive bortezomib intravenously once a week for the first 4 weeks. Prednisone will be taken orally o...
Eligibility Criteria
Inclusion
- Recipients of allogeneic stem cell transplantation with myeloablative or non-myeloablative conditioning regimens
- 100 days or more past stem cell transplantation
- Recipients of matched or mismatched, related or unrelated adult donor stem cells
- Must have cGVHD requiring systemic therapy
- No addition or subtraction of other immunosuppressive medications. The dose of immunosuppressive medicines may be adjusted based on the therapeutic range of that drug. However, if cGVHD occurs during a taper of immune suppression, the medication(s) may not be increased back up to therapeutic level, but will continue a the taper dose for the 15 week study duration
- Adequate bone marrow, hepatic and renal function as outlined in the protocol
- Does not require hemodialysis
- 18 years of age or older
- ECOG Performance Status of 0-2 or Karnofsky performance score of 70% or greater
- Life expectancy of more than 3 months
Exclusion
- Systemic steroid therapy in the 4 weeks prior to enrollment
- Active malignant disease after transplantation. Complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy will not be considered in this category
- Active uncontrolled infection
- Peripheral neuropathy CTC Grade 1 (or greater) with pain in the 4 weeks before enrollment. Other neurological deficits must be reviewed with the study PI prior to study entry
- Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Hypersensitivity to bortezomib, boron, or mannitol
- Female subject is pregnant or breast-feeding
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00815919
Start Date
December 1 2008
End Date
January 1 2013
Last Update
July 22 2015
Active Locations (1)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115