Campath-1H + FK506 and Methylprednisolone for GVHD

Breast Cancer Clinical Trial

Official title:

Phase II Clinical Trial Incorporating Alemtuzumab (Campath-1H) in Combination With FK506 and Methylprednisolone for Treatment of Severe Acute Graft vs Host Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00109993
• Other study ID #: CASE1Z04
• Secondary ID: P30CA043703CASE-
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2005
• Last updated: June 10, 2010
• Start date: January 2005
• Est. completion date: May 2007

Study information

• Verified date: June 2010
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Alemtuzumab, tacrolimus, and methylprednisolone may be an effective treatment for graft-versus-host disease caused by a donor stem cell transplant.

PURPOSE: This phase II trial is studying how well giving alemtuzumab together with tacrolimus and methylprednisolone works in treating acute graft-versus-host disease in patients who have undergone donor stem cell transplant.

Description:

OBJECTIVES:

Primary

• Determine the 4-week rate of complete response in patients with severe acute graft-vs-host disease (GVHD) treated with alemtuzumab, tacrolimus, and methylprednisolone within 100 days after undergoing allogeneic stem cell transplantation.

Secondary

• Determine the best response at 4 and 12 weeks in patients treated with this regimen.

• Determine 6-month survival of patients treated with this regimen.

• Determine the rate of infectious complications in patients treated with this regimen.

• Determine rate of chronic GVHD in patients treated with this regimen.

OUTLINE: This is an open-label, single-blind, multicenter study.

Patients receive methylprednisolone IV on days 1-3 and then orally or IV on days 4-14; tacrolimus IV continuously on days 1-7 and then orally once or twice daily on days 8-180, followed by a taper in the absence of chronic graft-vs-host disease; and alemtuzumab IV over 2 hours on days 4-6, 18, and 32. Treatment continues in the absence of unacceptable toxicity or the development of serious infection.

After completion of study treatment, patients are followed at 2 and 4 weeks.

PROJECTED ACCRUAL: A total of 9-34 patients will be accrued for this study within 8-12 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: May 2007
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of acute graft-vs-host disease (GVHD)

• Clinical grade C or D disease

• No grade C disease with single organ skin involvement

• Has undergone allogeneic stem cell transplantation within the past 100 days

• Absolute neutrophil count > 500/mm^3 (donor-derived [> 60% by peripheral blood lymphocyte chimerism analyses])

• No development of GVHD after prior donor lymphocyte infusion

• Must have received prior prophylactic cyclosporine or tacrolimus at the onset of acute GVHD

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• See Disease Characteristics

Hepatic

• No serologic evidence of active hepatitis B or C infection

Renal

• Creatinine = 3.5 mg/dL

• No requirement for dialysis

Cardiovascular

• No requirement for vasopressors

Pulmonary

• No requirement for a ventilator

Other

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after completion of study treatment

• No known HIV positivity

• No active uncontrolled infection

• No other organ dysfunction

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Chronic Myeloproliferative Disorders
• Gestational Trophoblastic Disease
• Gestational Trophoblastic Tumor
• Graft Versus Host Disease
• Graft vs Host Disease
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Diseases
• Myeloproliferative Disorders
• Neoplasms, Germ Cell and Embryonal
• Neoplasms, Plasma Cell
• Neuroblastoma
• Ovarian Cancer
• Plasmacytoma
• Preleukemia
• Testicular Germ Cell Tumor
• Testicular Neoplasms
• Trophoblastic Neoplasms

Intervention

Biological:
• alemtuzumab
alemtuzumab IV over 2 hours on days 4-6, 18, and 32

Drug:
• methylprednisolone
methylprednisolone IV on days 1-3 and then orally or IV on days 4-14
• tacrolimus
tacrolimus IV continuously on days 1-7 and then orally once or twice daily on days 8-180, followed by a taper in the absence of chronic graft-vs-host disease

Locations

Country	Name	City	State
United States	Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	Mt. Sinai Medical Center	New York	New York
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Oregon Health Sciences University	Portland	Oregon
United States	Texas Transplant Institute	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft-vs-host disease response		1, 2, 3, and 4 months	No
Secondary	Incidence of serious infections by clinical, radiologic, and microbiologic assessments		1,2,3, and 4 months	No