DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Efalizumab in Treating Patients With Graft-Versus-Host Disease of the Skin That Did Not Respond to Previous Steroids

Information source: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Graft Versus Host Disease

Intervention: efalizumab (Biological)

Phase: N/A

Status: Completed

Sponsored by: UNC Lineberger Comprehensive Cancer Center

Official(s) and/or principal investigator(s):
Thomas C. Shea, MD, Principal Investigator, Affiliation: UNC Lineberger Comprehensive Cancer Center

Summary

RATIONALE: Efalizumab may be an effective treatment for graft-versus-host disease of the skin caused by a donor stem cell transplant. PURPOSE: This clinical trial is studying the side effects and how well efalizumab works in treating patients with graft-versus-host disease of the skin that did not respond to previous steroids.

Clinical Details

Official title: Weekly Subcutaneous Efalizumab for the Treatment of Steroid Refractory Graft-Versus-Host Disease of the Skin and Liver

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Number of subjects experiencing adverse events

Secondary outcome:

Feasibility of digital imaging

Feasibility of serial skin biopsies

Overall complete response rate

Detailed description: OBJECTIVES: Primary

- Assess the general safety of efalizumab in patients with cutaneous graft-vs-host

disease (GVHD).

- Study the feasibility of digital imaging to objectively quantify cutaneous GVHD.

- Evaluate the feasibility of serial skin biopsies to monitor disease response to

efalizumab in patients with cutaneous GVHD. Secondary

- Assess the overall complete response rate in patients treated with this drug.

- Assess the overall cutaneous response rate (complete cutaneous response rate and

partial cutaneous response rate) in patients treated with this drug.

- Assess the overall hepatic response rate (complete hepatic response rate and partial

hepatic response rate) in patients treated with this drug.

- Assess the duration of any responses observed.

- Assess the effect of this drug on overall patient survival.

- Use the preliminary efficacy and toxicity data collected in this small exploratory

study to decide on the appropriateness of a larger, subsequent phase II trial to more formally assess toxicity and efficacy of this drug in this patient population.

- Collect pharmacokinetic data on this drug in these patients.

OUTLINE: Patients receive efalizumab subcutaneously once weekly for 8 weeks (total of 8 doses). Digital photographs of body regions are taken for determination of disease involved body surface area. Skin biopsies are obtained before and after treatment and analyzed for LFA-1, ICAM-1, CD4, CD8, and possibly CD20 by immunohistochemistry. After completion of study therapy, patients are followed at 1 and 9 weeks.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

DISEASE CHARACTERISTICS:

- Diagnosis of acute or chronic cutaneous graft-versus-host disease (GVHD), as

evidenced by an erythematous maculopapular rash which is felt to be clinically consistent with GVHD

- Pathologic findings from skin biopsy consistent with GVHD

- Sclerodermatous skin changes may be present but will not by themselves be

considered adequate for study enrollment

- Patients with concurrent hepatic GVHD are eligible

- Patients with liver dysfunction are encouraged but not required to undergo

hepatic biopsy in order to document that liver injury is the result of GVHD

- Patients with a pretreatment serum bilirubin ≥ 2. 0 mg/dL and biopsy-confirmed

cutaneous GVHD will be assumed to demonstrate hepatic GVHD if no other cause for the bilirubin elevation can be identified

- Underwent allogeneic hematopoietic stem cell transplantation (peripheral blood stem

cells and/or bone marrow, regardless of the degree of HLA matching) ≥ 30 days prior to study enrollment

- Steroid refractory disease, defined by 1 of the following criteria:

- Worsening skin or liver disease despite 1 week of treatment with the equivalent

of 1 mg/kg of methylprednisolone

- Failed to achieve a 50% reduction in the body surface area involved by GVHD or a

50% reduction in the total serum bilirubin after 4 weeks of treatment with the equivalent of at least 0. 5 mg/kg of methylprednisolone

- Requires the equivalent of at least 0. 5 mg/kg of methylprednisolone to maintain

a response after 8 weeks of steroid therapy

- Progression of cutaneous or hepatic GVHD after a prior history of treatment with

at least 8 weeks of corticosteroids now requiring the reintroduction of corticosteroids (the equivalent of greater than 10 mg/day of methylprednisolone)

- Not improving or progressing on alternative immunosuppressive agents after prior

steroid refractoriness had been established PATIENT CHARACTERISTICS:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- Absolute neutrophil count (ANC) > 1,000/μL

- Platelet count ≥ 20,000/μL

- Serum creatinine ≤ 3. 0 mg/dL

- No HIV infection

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

- At least 2 terminal half-lives since prior and no concurrent infliximab, daclizumab,

etanercept, rituximab, antithymocyte globulin (ATG), or denileukin diftitox

Locations and Contacts

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina 27599-7295, United States
Additional Information

Lineberger Comprehensive Cancer Center website

National Cancer Institute (NCI)

Starting date: May 2007
Last updated: February 1, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017