Phase II Clinical Trial Incorporating Alemtuzumab (Campath-1H) in Combination With FK506 and Methylprednisolone for Treatment of Severe Acute Graft vs Host Disease
18 Years
N/A
Both
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
Trial Information
Phase II Clinical Trial Incorporating Alemtuzumab (Campath-1H) in Combination With FK506 and Methylprednisolone for Treatment of Severe Acute Graft vs Host Disease
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Graft-vs-host disease response
Outcome Time Frame:
1, 2, 3, and 4 months
Safety Issue:
No
Principal Investigator
Mary Laughlin, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CASE1Z04
NCT ID:
NCT00109993
Start Date:
January 2005
Completion Date:
May 2007
Related Keywords:
- 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
- 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
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II marginal zone lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- poor prognosis metastatic gestational trophoblastic tumor
- previously treated myelodysplastic syndromes
- recurrent adult acute lymphoblastic leukemia
- recurrent adult acute myeloid leukemia
- recurrent adult Burkitt lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult Hodgkin lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- recurrent mantle cell lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- recurrent marginal zone lymphoma
- recurrent neuroblastoma
- recurrent ovarian epithelial cancer
- recurrent ovarian germ cell tumor
- recurrent small lymphocytic lymphoma
- recurrent malignant testicular germ cell tumor
- refractory chronic lymphocytic leukemia
- refractory multiple myeloma
- refractory hairy cell leukemia
- relapsing chronic myelogenous leukemia
- secondary acute myeloid leukemia
- secondary myelodysplastic syndromes
- splenic marginal zone lymphoma
- stage I multiple myeloma
- stage III adult Burkitt lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage II ovarian epithelial cancer
- stage III chronic lymphocytic leukemia
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III mantle cell lymphoma
- stage III marginal zone lymphoma
- stage III multiple myeloma
- stage III ovarian epithelial cancer
- stage III small lymphocytic lymphoma
- stage III malignant testicular germ cell tumor
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- stage IV adult Burkitt lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV breast cancer
- stage IV chronic lymphocytic leukemia
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV mantle cell lymphoma
- stage IV marginal zone lymphoma
- stage IV ovarian epithelial cancer
- stage IV small lymphocytic lymphoma
- Breast Neoplasms
- Neoplasms
- Graft vs Host Disease
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Neuroblastoma
- Ovarian Neoplasms
- Trophoblastic Neoplasms
- Lymphoma, Large-Cell, Immunoblastic
- Neoplasms, Germ Cell and Embryonal
- Gestational Trophoblastic Neoplasms
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
|---|---|
| Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
| Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
| Oregon Health Sciences University | Portland, Oregon |
| Texas Transplant Institute | San Antonio, Texas 78229 |
| Mt. Sinai Medical Center | New York, New York 10029 |
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |
