Campath-1H + FK506 and Methylprednisolone for GVHD
This study has been completed.
Sponsor:
Case Comprehensive Cancer Center
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00109993
First received: May 3, 2005
Last updated: June 10, 2010
Last verified: June 2010
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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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
familial acute myeloid leukemia with mutated CEBPA
mycosis fungoides
neuroblastoma
Sézary syndrome
MedlinePlus related topics:
Acute Myeloid Leukemia
Breast Cancer
Cancer
Cancer and Pregnancy
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
Neuroblastoma
Ovarian Cancer
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
Tacrolimus
Alemtuzumab
U.S. FDA Resources
Further study details as provided by Case Comprehensive Cancer Center:
Primary Outcome Measures:
- Graft-vs-host disease response [ Time Frame: 1, 2, 3, and 4 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of serious infections by clinical, radiologic, and microbiologic assessments [ Time Frame: 1,2,3, and 4 months ] [ Designated as safety issue: No ]
| Enrollment: | 34 |
| Study Start Date: | January 2005 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
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
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00109993
Locations
| 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
Investigators
| Principal Investigator: | Mary Laughlin, MD | Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Mary Laughlin, MD, Ireland Cancer Center at University Hospitals Case Medical Center,Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00109993 History of Changes |
| Other Study ID Numbers: | CASE1Z04, P30CA043703, CASE-CWRU-1Z04, CWRU-060419, CASE-1Z04 |
| Study First Received: | May 3, 2005 |
| Last Updated: | June 10, 2010 |
| Health Authority: | United States: Federal Government |
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:
|
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 Neoplasms by Site Breast Diseases Skin Diseases Immune System Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 21, 2013