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Campath-1H + FK506 and Methylprednisolone for GVHD

Primary Purpose

Breast Cancer, Chronic Myeloproliferative Disorders, Gestational Trophoblastic Tumor

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
alemtuzumab
methylprednisolone
tacrolimus
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mt. Sinai Medical Center
  • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
  • Oregon Health Sciences University
  • Western Pennsylvania Hospital
  • Texas Transplant Institute

Outcomes

Primary Outcome Measures

Graft-vs-host disease response

Secondary Outcome Measures

Incidence of serious infections by clinical, radiologic, and microbiologic assessments

Full Information

First Posted
May 3, 2005
Last Updated
June 10, 2010
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00109993
Brief Title
Campath-1H + FK506 and Methylprednisolone for GVHD
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 Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
alemtuzumab
Intervention Description
alemtuzumab IV over 2 hours on days 4-6, 18, and 32
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Description
methylprednisolone IV on days 1-3 and then orally or IV on days 4-14
Intervention Type
Drug
Intervention Name(s)
tacrolimus
Intervention Description
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
Primary Outcome Measure Information:
Title
Graft-vs-host disease response
Time Frame
1, 2, 3, and 4 months
Secondary Outcome Measure Information:
Title
Incidence of serious infections by clinical, radiologic, and microbiologic assessments
Time Frame
1,2,3, and 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Laughlin, MD
Organizational Affiliation
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mt. Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-7284
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Texas Transplant Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Campath-1H + FK506 and Methylprednisolone for GVHD

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