Campath-1H + FK506 and Methylprednisolone for GVHD

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Alemtuzumab; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Tacrolimus

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