Bortezomib Plus Prednisone for Initial Therapy of Chronic Graft Versus Host Disease
Information source: Dana-Farber Cancer Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Graft Versus Host Disease
Intervention: bortezomib (Drug); Prednisone (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Dana-Farber Cancer Institute Official(s) and/or principal investigator(s): John Koreth, MBBS, DPhil, Principal Investigator, Affiliation: Dana-Farber Cancer Institute
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 combination in this patient population. Chronic GVHD is a medical condition that
may occur after allogeneic stem cell transplantation. The donor's immune system may
recognize the participants body (the host) as foreign and attempt to "reject" it.
Bortezomib has been used in other research studies, and information from those studies
suggests that this drug may help to control the abnormal immune responses that underlie
cGVHD.
Clinical Details
Official title: A Phase II Trial of Bortezomib (Velcade) Plus Prednisone for Initial Therapy of Chronic Graft Versus Host Disease
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Overall Response Rate After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD
Secondary outcome: Proportion of Patients Tolerating >50% Steroid Dose Reduction After a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHDThe Toxicity of a 15 Week Course of Bortezomib Plus Prednisone in Patients With cGVHD Proportion of cGVHD Patients Requiring Prednisone by 1 Year After Therapy Overall and cGVHD Progression-free Survival by 1 Year After Therapy
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 on a daily basis and dose reduction may be initiated
after 1 cycle of therapy.
- During all treatment cycles, participants will have the following: physical exam and
blood work. At the end of cycle 3 (week 15) the participants cGVHD will be evaluated.
These assessments may include an eye examination, a skin examination, a pulmonary
function test and/or, a flexion assessment test.
- Participants will receive 3 cycles of bortezomib.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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
Locations and Contacts
Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States
Additional Information
Starting date: December 2008
Last updated: June 29, 2015
|