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Status:

COMPLETED

Campath-1H + FK506 and Methylprednisolone for GVHD

Lead Sponsor:

Case Comprehensive Cancer Center

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Breast Cancer

Chronic Myeloproliferative Disorders

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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...

Detailed 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 10...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    January 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2007

    Estimated Enrollment :

    34 Patients enrolled

    Trial Details

    Trial ID

    NCT00109993

    Start Date

    January 1 2005

    End Date

    May 1 2007

    Last Update

    June 11 2010

    Active Locations (6)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 2 (6 locations)

    1

    Mt. Sinai Medical Center

    New York, New York, United States, 10029

    2

    Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    Cleveland, Ohio, United States, 44106-7284

    3

    Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

    Cleveland, Ohio, United States, 44195

    4

    Oregon Health Sciences University

    Portland, Oregon, United States, 97239