Clinical Trial: Alemtuzumab, Tacrolimus, and Methylprednisolone in Treating Acute Graft-Versus-Host Disease in Patients Who Have Undergone Donor Stem Cell Transplant

This study is currently recruiting patients.

Sponsors and Collaborators: Ireland Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

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

MedlinePlus related topics:  Breast Cancer;   Cancer;   Cancer Alternative Therapy;   Endocrine Diseases;   Immune System and Disorders;   Neuroblastoma;   Reproductive Health
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Alemtuzumab, Tacrolimus, and Methylprednisolone for Severe Acute Graft-Versus-Host Disease in Patients Who Have Undergone Allogeneic Stem Cell Transplantation

Further Study Details: 

OBJECTIVES: Primary

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.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00109993


Ohio
      Cleveland Clinic Taussig Cancer Center, Cleveland,  Ohio,  44195,  United States; Recruiting
Brian James Bolwell, MD  216-444-6922 

      Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland,  Ohio,  44106-7284,  United States; Recruiting
Mary J. Laughlin, MD  216-844-5182    mjl13@po.cwru.edu 

Study chairs or principal investigators

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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

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


Source: ClinicalTrials.gov
Cache Date: May 18, 2005

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