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Campath-1H + FK506 and Methylprednisolone for GVHD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00109993
Recruitment Status : Completed
First Posted : May 4, 2005
Last Update Posted : June 11, 2010
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Case Comprehensive Cancer Center

Study Description
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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 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 or disease Intervention/treatment Phase
Breast Cancer Chronic Myeloproliferative Disorders Gestational Trophoblastic Tumor Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Neuroblastoma Ovarian Cancer Testicular Germ Cell Tumor Biological: alemtuzumab Drug: methylprednisolone Drug: tacrolimus Phase 2

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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Phase II Clinical Trial Incorporating Alemtuzumab (Campath-1H) in Combination With FK506 and Methylprednisolone for Treatment of Severe Acute Graft vs Host Disease
Study Start Date : January 2005
Actual Primary Completion Date : June 2006
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Cutaneous T-cell Lymphoma Follicular Lymphoma Homologous Wasting Disease Ovarian Cancer Ovarian Epithelial Cancer Myeloid Leukemia Chronic Myeloid Leukemia Primary Myelofibrosis Acute Myeloid Leukemia Acute Non Lymphoblastic Leukemia Myelodysplastic Syndromes Chronic Myelomonocytic Leukemia Juvenile Myelomonocytic Leukemia Multiple Myeloma Neuroblastoma B-cell Lymphoma Diffuse Large B-Cell Lymphoma Chronic Lymphocytic Leukemia Mantle Cell Lymphoma Mycosis Fungoides Acute Lymphoblastic Leukemia Lymphoblastic Lymphoma Hodgkin Lymphoma Hairy Cell Leukemia Marginal Zone Lymphoma Plasmablastic Lymphoma Lymphoma, Large-cell, Immunoblastic Sezary Syndrome Chronic Myeloproliferative Disorders Plasmacytoma Myelodysplastic/myeloproliferative Disease Gestational Trophoblastic Tumor Burkitt Lymphoma Ovarian Germ Cell Tumor Chronic Neutrophilic Leukemia Neuroepithelioma

Arms and Interventions
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Intervention Details:
  • Biological: alemtuzumab
    alemtuzumab IV over 2 hours on days 4-6, 18, and 32
  • Drug: methylprednisolone
    methylprednisolone IV on days 1-3 and then orally or IV on days 4-14
  • Drug: tacrolimus
    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

Outcome Measures
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Primary Outcome Measures :
  1. Graft-vs-host disease response [ Time Frame: 1, 2, 3, and 4 months ]

Secondary Outcome Measures :
  1. Incidence of serious infections by clinical, radiologic, and microbiologic assessments [ Time Frame: 1,2,3, and 4 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00109993


Locations
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United States, New York
Mt. Sinai Medical Center
New York, New York, United States, 10029
United States, Ohio
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-7284
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States, 15224
United States, Texas
Texas Transplant Institute
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Mary Laughlin, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
More Information
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Responsible Party: Mary Laughlin, MD, Ireland Cancer Center at University Hospitals Case Medical Center,Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00109993    
Other Study ID Numbers: CASE1Z04
P30CA043703 ( U.S. NIH Grant/Contract )
CASE-CWRU-1Z04 ( Other Identifier: Case Comprehensive Cancer Center )
CWRU-060419
CASE-1Z04 ( Other Identifier: Case Comprehensive Cancer Center )
First Posted: May 4, 2005    Key Record Dates
Last Update Posted: June 11, 2010
Last Verified: June 2010
Keywords provided by Case Comprehensive Cancer Center:
graft versus host disease
accelerated phase chronic myelogenous leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
atypical chronic myeloid leukemia
blastic phase chronic myelogenous leukemia
chronic eosinophilic leukemia
chronic idiopathic myelofibrosis
chronic myelomonocytic leukemia
chronic neutrophilic leukemia
 chronic phase chronic myelogenous leukemia
de novo myelodysplastic syndromes
disseminated neuroblastoma
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
myelodysplastic/myeloproliferative disease, unclassifiable
nodal marginal zone B-cell lymphoma
noncontiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse large cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II adult immunoblastic large cell lymphoma
noncontiguous stage II adult lymphoblastic lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma
Additional relevant MeSH terms:
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Lymphoma
Breast Neoplasms
Neoplasms
Leukemia
Multiple Myeloma
Neoplasms, Plasma Cell
Preleukemia
Neuroblastoma
Neoplasms, Germ Cell and Embryonal
Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Myelodysplastic Syndromes
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Graft vs Host Disease
 Syndrome
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Disease
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias