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.

Condition	Treatment or Intervention	Phase
Breast Cancer Endocrine Cancer female reproductive cancer Graft Versus Host Disease hematopoietic and lymphoid cancer Neuroblastoma	Drug: alemtuzumab  Drug: methylprednisolone  Drug: tacrolimus  Procedure: antibody therapy  Procedure: biological response modifier therapy  Procedure: complications of therapy assessment/management  Procedure: graft versus host disease prophylaxis/therapy  Procedure: monoclonal antibody therapy  Procedure: supportive care/therapy	Phase II

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00109993

Ohio
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States; Recruiting
      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106-7284,  United States; Recruiting

Study chairs or principal investigators

Mary J. Laughlin, MD,  Study Chair,  Ireland Cancer Center   

Study ID Numbers:  CDR0000424453; CWRU-CASE-1Z04; CWRU-060419
Record last reviewed:  April 2005
Last Updated:  May 3, 2005
Record first received:  May 3, 2005
ClinicalTrials.gov Identifier:  NCT00109993
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-17