Bortezomib Plus Prednisone for Initial Therapy of Chronic Graft Versus Host Disease

NCT ID: NCT00815919

Last Updated: 2015-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2013-01-31

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 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.

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.

Conditions

Chronic Graft Versus Host Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Velcade (bortezomib)

Group Type: EXPERIMENTAL

bortezomib

Intervention Type: DRUG

Given intravenously at a dose of 1.3 mg/m\^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles

Prednisone

Intervention Type: DRUG

Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.

Interventions

bortezomib

Given intravenously at a dose of 1.3 mg/m\^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles

Intervention Type: DRUG

Prednisone

Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.

Intervention Type: DRUG

Other Intervention Names

Velcade

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

John Koreth, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John Koreth, MBBS, DPhil

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

08-191

Identifier Type: -

Identifier Source: org_study_id