Campath-1H + FK506 and Methylprednisolone for GVHD

Case Comprehensive Cancer Center (Case CCC)

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Neuroblastoma

Gestational Trophoblastic Tumor

Chronic Myeloproliferative Disorders

Ovarian Cancer

Leukemia

Myelodysplastic/Myeloproliferative Diseases

Myelodysplastic Syndromes

Graft Versus Host Disease

Multiple Myeloma and Plasma Cell Neoplasm

Lymphoma

Testicular Germ Cell Tumor

Treatments

Drug: methylprednisolone

Drug: tacrolimus

Biological: alemtuzumab

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00109993

CASE1Z04

CASE-1Z04 (Other Identifier)

P30CA043703 (U.S. NIH Grant/Contract)

CASE-CWRU-1Z04 (Other Identifier)

CWRU-060419

Details and patient eligibility

About

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.

Full 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.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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