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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 cGVHD

The 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

Page last updated: August 23, 2015

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