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| Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00096161 |
Purpose
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by radiation therapy or chemotherapy used to kill cancer cells. Infusions of donor white blood cells may decrease the body's rejection of the transplanted peripheral stem cells. Pentostatin, mycophenolate mofetil, and cyclosporine may also prevent this from happening.
PURPOSE: This phase I/II trial is studying the side effects of pentostatin and donor white blood cells and to see how well they work in preventing graft rejection in cancer patients who have undergone a donor stem cell transplantation.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Neuroblastoma Ovarian Cancer Sarcoma Testicular Germ Cell Tumor |
Drug: cyclosporine Drug: mycophenolate mofetil Drug: pentostatin Drug: therapeutic allogeneic lymphocytes |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Pentostatin and Donor Lymphocyte Infusion for Low Donor T-Cell Chimerism After Hematopoietic Cell Transplantation Using Nonmyeloablative Conditioning - A Multi-Center Trial |
| Estimated Enrollment: | 80 |
| Study Start Date: | May 2003 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive pentostatin IV over a few seconds or 20-30 minutes on day -2 and donor lymphocytes IV over 15-30 minutes on day 0. Treatment may repeat once beginning at least 28 days later. Patients are evaluated once 20 patients have been treated. If this regimen is found to be ineffective, subsequent patients receive pentostatin and donor lymphocytes as before, as well as oral cyclosporine twice daily beginning on day -3 and continuing until day 56. Patients also receive oral mycophenolate mofetil once daily beginning on day 0 and continuing until day 27.
Patients are followed monthly for 3 months, every 3 months for 6 months, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | up to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Has undergone prior allogeneic stem cell transplantation for cancer
Low or falling donor CD3-positive T-cell peripheral blood chimerism on 2 separate consecutive evaluations at least 14 days apart as indicated by 1 of the following:
Evidence of disease allowed provided disease is persistent and stable compared to the status prior to transplantation
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
No grade II-IV acute GVHD
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Colorado | |
| Rocky Mountain Cancer Centers - Denver Midtown | Recruiting |
| Denver, Colorado, United States, 80218 | |
| Contact: Michael B. Maris, MD 303-388-4876 | |
| United States, Utah | |
| Huntsman Cancer Institute at University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84132 | |
| Contact: Michael A. Pulsipher, MD 801-581-2121 michael.pulsipher@hsc.utah.edu | |
| LDS Hospital | Recruiting |
| Salt Lake City, Utah, United States, 84143 | |
| Contact: Finn B. Petersen, MD 801-408-1818 ldfpeter@ihc.com | |
| United States, Washington | |
| Fred Hutchinson Cancer Research Center | Recruiting |
| Seattle, Washington, United States, 98109-1024 | |
| Contact: Brenda Sandmaier, MD 206-667-4961 | |
| Seattle Cancer Care Alliance | Recruiting |
| Seattle, Washington, United States, 98109-1023 | |
| Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824 | |
| Veterans Affairs Medical Center - Seattle | Recruiting |
| Seattle, Washington, United States, 98108 | |
| Contact: Thomas R. Chauncey, MD, PhD 206-762-1010 | |
| Italy | |
| Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino | Recruiting |
| Turin, Italy, 10126 | |
| Contact: Benedetto Bruno, MD, PhD 39-339-112-9064 benedetto.bruno@unito.it | |
| Principal Investigator: | Brenda Sandmaier, MD | Fred Hutchinson Cancer Research Center |
More Information
| Responsible Party: | Fred Hutchinson Cancer Research Center ( Brenda Sandmaier ) |
| Study ID Numbers: | CDR0000391025, FHCRC-1825.00, SUPERGEN-FHCRC-1825.00 |
| Study First Received: | November 9, 2004 |
| Last Updated: | December 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00096161 |
| Health Authority: | Unspecified |
|
graft versus host disease adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission childhood acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission childhood chronic myelogenous leukemia chronic myelomonocytic leukemia chronic phase chronic myelogenous leukemia chronic eosinophilic leukemia chronic idiopathic myelofibrosis chronic neutrophilic leukemia de novo myelodysplastic syndromes myelodysplastic/myeloproliferative disease, unclassifiable secondary myelodysplastic syndromes disseminated neuroblastoma |
extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma stage III marginal zone lymphoma stage IV marginal zone lymphoma juvenile myelomonocytic leukemia 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 |
|
Blast Crisis Cyclosporine Chronic myelogenous leukemia Malignant mesenchymal tumor Lymphoma, small cleaved-cell, diffuse Urogenital Neoplasms Cyclosporins Lymphoma, large-cell, immunoblastic Preleukemia Hemorrhagic Disorders Neoplasm Metastasis Neuroepithelioma Rhabdomyosarcoma Endocrine Gland Neoplasms Myelodysplastic syndromes |
Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Blood Coagulation Disorders Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Genital Neoplasms, Female Acute myelogenous leukemia Breast Neoplasms Testicular Neoplasms Leukemia, Myeloid Myelodysplastic myeloproliferative disease Leukemia, Myeloid, Accelerated Phase B-cell lymphomas Sarcoma Lymphoma, Non-Hodgkin |
|
Anti-Infective Agents Neoplasms by Histologic Type Disease Immunologic Factors Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions |
Adnexal Diseases Neoplasms Neoplasms by Site Pathologic Processes Therapeutic Uses Antifungal Agents Syndrome Cardiovascular Diseases Antirheumatic Agents Neoplasms, Neuroepithelial Dermatologic Agents |
