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Sponsors and Collaborators: |
Cancer and Leukemia Group B National Cancer Institute (NCI) Eastern Cooperative Oncology Group |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00074035 |
RATIONALE: Pentostatin may be effective in treating chronic graft-versus-host disease by stopping the immune system from rejecting donor stem cells or donor white blood cells.
PURPOSE: This phase II trial is studying how well pentostatin works in treating patients with chronic graft-versus-host disease that is refractory (not responsive) to treatment with steroids.
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 Neuroblastoma Ovarian Cancer Testicular Germ Cell Tumor |
Drug: pentostatin |
Phase II |
Genetics Home Reference related topics: | aceruloplasminemia breast cancer hemophilia |
MedlinePlus related topics: | Breast Cancer Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Lymphoma Multiple Myeloma Neuroblastoma Ovarian Cancer |
ChemIDplus related topics: | Pentostatin |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label |
Official Title: | A Phase II Trial Of Intravenous Pentostatin For The Treatment Of Patients With Refractory Chronic Graft-Versus-Host Disease |
Estimated Enrollment: | 37 |
Study Start Date: | December 2003 |
Estimated Primary Completion Date: | June 2005 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive pentostatin IV over 20-30 minutes on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients who achieve a complete response after 6 courses receive 4 additional courses. Patients who achieve a partial response, minor response, or stable disease after 6 courses may receive up to 6 additional courses.
Patients are followed every 4 weeks for 1 year, every 3 months for 2 years, and then annually for 5 years.
PROJECTED ACCRUAL: Approximately 37 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed chronic graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation or donor lymphocyte infusion
Extensive stage disease requiring systemic immunosuppressive therapy, defined according to Seattle criteria as 1 of the following:
Limited skin involvement or hepatic involvement with any of the following:
Failed prior corticosteroid therapy, meeting 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Delaware | |||||
CCOP - Christiana Care Health Services | |||||
Newark, Delaware, United States, 19713 | |||||
Tunnell Cancer Center at Beebe Medical Center | |||||
Lewes, Delaware, United States, 19958 | |||||
United States, Illinois | |||||
University of Chicago Cancer Research Center | |||||
Chicago, Illinois, United States, 60637-1470 | |||||
University of Illinois Cancer Center | |||||
Chicago, Illinois, United States, 60612-7243 | |||||
United States, Maryland | |||||
Greenebaum Cancer Center at University of Maryland Medical Center | |||||
Baltimore, Maryland, United States, 21201 | |||||
Union Hospital Cancer Program at Union Hospital | |||||
Elkton MD, Maryland, United States, 21921 | |||||
United States, Minnesota | |||||
Mayo Clinic Cancer Center | |||||
Rochester, Minnesota, United States, 55905 | |||||
United States, New Jersey | |||||
Cancer Institute of New Jersey at Cooper - Voorhees | |||||
Voorhees, New Jersey, United States, 08043 | |||||
United States, New York | |||||
New York Weill Cornell Cancer Center at Cornell University | |||||
New York, New York, United States, 10021 | |||||
United States, North Carolina | |||||
Duke Comprehensive Cancer Center | |||||
Durham, North Carolina, United States, 27710 | |||||
Wake Forest University Comprehensive Cancer Center | |||||
Winston-Salem, North Carolina, United States, 27157-1096 | |||||
United States, Ohio | |||||
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | |||||
Columbus, Ohio, United States, 43210-1240 | |||||
United States, Pennsylvania | |||||
Abramson Cancer Center of the University of Pennsylvania | |||||
Philadelphia, Pennsylvania, United States, 19104-4283 | |||||
Fox Chase Cancer Center - Philadelphia | |||||
Philadelphia, Pennsylvania, United States, 19111-2497 | |||||
Western Pennsylvania Cancer Institute at Western Pennsylvania Hospital | |||||
Pittsburgh, Pennsylvania, United States, 15224-1791 | |||||
United States, Virginia | |||||
Virginia Commonwealth University Massey Cancer Center | |||||
Richmond, Virginia, United States, 23298-0037 |
Cancer and Leukemia Group B |
National Cancer Institute (NCI) |
Eastern Cooperative Oncology Group |
Study Chair: | Sherif S. Farag, MD, PhD | Indiana University Melvin and Bren Simon Cancer Center |
Investigator: | Nelson J. A. Chao, MD | Duke University |
Study Chair: | Edward A. Stadtmauer, MD | University of Pennsylvania |
Investigator: | Hillard M. Lazarus, MD | Case Comprehensive Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000341678, CALGB-100101, ECOG-1010 |
First Received: | December 10, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00074035 |
Health Authority: | United States: Federal Government |
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