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| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Fred Hutchinson Cancer Research Center |
| ClinicalTrials.gov Identifier: | NCT00078858 |
Purpose
RATIONALE: Giving different schedules of mycophenolate mofetil and cyclosporine may be effective in reducing graft-versus-host disease in patients undergoing donor peripheral stem cell transplantation for hematologic malignancies (cancer) and metastatic renal cell carcinoma.
PURPOSE: This phase I/II trial is studying the side effects and best way to give mycophenolate mofetil and cyclosporine and to see how well they work in reducing graft-versus-host disease in treating patients who are undergoing donor peripheral stem cell transplantation for hematologic cancer or metastatic renal cell carcinoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Myeloproliferative Disorders Graft Versus Host Disease Kidney Cancer Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Biological: graft-versus-tumor induction therapy Drug: cyclosporine Drug: fludarabine phosphate Drug: mycophenolate mofetil Procedure: peripheral blood stem cell transplantation Radiation: radiation therapy |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Prolonged Mycophenolate Mofetil And Truncated Cyclosporine Postgrafting Immunosuppression To Reduce Life-Threatening GVHD After Unrelated Donor Peripheral Blood Cell Transplantation Using Nonmyeloablative Conditioning For Patients With Hematologic Malignancies And Renal Cell Carcinoma - A Multi-Center Trial |
| Study Start Date: | September 2003 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients are followed at 6 months, 12 months, 18 months, and 24 months and then annually for 5 years after HSCT.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 1.5 years.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of either of the following:
Hematologic malignancy
Meeting 1 of the following criteria:
Including, but not limited to the following:
Intermediate- or high-grade non-Hodgkin's lymphoma (NHL)
Low-grade NHL
Chronic lymphocytic leukemia
Hodgkin's lymphoma
Multiple myeloma
Acute myeloid leukemia (AML)
Acute lymphoblastic leukemia
Chronic myelogenous leukemia (CML)
Myelodysplastic syndromes (MDS) or myeloproliferative disorder
Metastatic renal cell carcinoma (RCC) not amenable to surgical cure OR history of or active histologically or radiologically confirmed metastatic disease, including 1 of the following histological types:
Available unrelated donor
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, California | |
| Stanford Cancer Center at Stanford University Medical Center | |
| Stanford, California, United States, 94305-5623 | |
| United States, Colorado | |
| Rocky Mountain Cancer Centers - Denver Midtown | |
| Denver, Colorado, United States, 80218 | |
| United States, Georgia | |
| Winship Cancer Institute of Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Oregon | |
| Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97239-3098 | |
| United States, Utah | |
| Huntsman Cancer Institute at University of Utah | |
| Salt Lake City, Utah, United States, 84112 | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
| United States, Wisconsin | |
| Medical College of Wisconsin Cancer Center | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Germany | |
| Universitaet Leipzig | |
| Leipzig, Germany, D-04103 | |
| Universitaetsklinikum Tuebingen | |
| Tuebingen, Germany, D-72076 | |
| Italy | |
| Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino | |
| Turin, Italy, 10126 | |
| Study Chair: | Brenda Sandmaier, MD | Fred Hutchinson Cancer Research Center |
More Information
| Responsible Party: | Brenda Sandmaier, MD, FHCRC |
| ClinicalTrials.gov Identifier: | NCT00078858 History of Changes |
| Other Study ID Numbers: | 1668.00, FHCRC-1668.00, CDR0000346473 |
| Study First Received: | March 8, 2004 |
| Last Updated: | November 16, 2011 |
| Health Authority: | United States: Federal Government; United States: Food and Drug Administration; United States: Institutional Review Board |
|
graft versus host disease recurrent renal cell cancer stage IV renal cell cancer recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma recurrent childhood small noncleaved cell lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma |
chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia refractory anemia with ringed sideroblasts polycythemia vera essential thrombocythemia recurrent/refractory childhood Hodgkin lymphoma refractory multiple myeloma adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia untreated childhood acute lymphoblastic leukemia untreated childhood acute myeloid leukemia and other myeloid malignancies refractory chronic lymphocytic leukemia clear cell renal cell carcinoma |
|
Neoplasms Carcinoma Carcinoma, Renal Cell Kidney Neoplasms Graft vs Host Disease Leukemia Lymphoma Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Hematologic Neoplasms Myelodysplastic-Myeloproliferative Diseases |
Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases Immune System Diseases Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |