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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00301860 |
RATIONALE: Giving chemotherapy before a donor peripheral blood stem cell transplant helps stop both the growth of cancer cells and the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving chemotherapy, such as fludarabine and melphalan, and antithymocyte globulin before transplant and cyclosporine and methotrexate after transplant may stop this from happening.
PURPOSE: This clinical trial is studying how well donor stem cell transplant, using low-dose chemotherapy and antithymocyte globulin, followed by donor white blood cell infusions work in treating young patients with hematologic cancer.
Condition | Intervention |
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Leukemia Lymphoma |
Drug: anti-thymocyte globulin Drug: cyclosporine Drug: filgrastim Drug: fludarabine phosphate Drug: melphalan Drug: methotrexate Drug: therapeutic allogeneic lymphocytes Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Feasibility of Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation Followed by Donor Lymphocyte Infusions for Children at High Risk for Complications With Conventional Transplantation |
Estimated Enrollment: | 10 |
Study Start Date: | January 2003 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a pilot study.
At the completion of study treatment, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following hematopoietic malignancies:
Considered at high risk (> 30%) of toxic death with standard hematopoietic stem cell transplantation (HSCT), as indicated by at least one of the following:
History of disseminated fungal infection during chemotherapy OR currently receiving antifungal agents OR history of ≥ 2 septic episodes (confirmed by cultures) that required ICU support
Patients with improving fungal or other infections eligible
Failed conventional therapies and not eligible for myeloablative protocols
Unrelated or related donor available, meeting the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 |
Study Chair: | Biljana Horn, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000462439, UCSF-02164, UCSF-H10216-21819-03 |
Study First Received: | March 9, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00301860 |
Health Authority: | United States: Federal Government |
childhood acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia recurrent childhood small noncleaved cell lymphoma juvenile myelomonocytic leukemia chronic phase chronic myelogenous leukemia |
accelerated phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia recurrent childhood large cell lymphoma recurrent childhood lymphoblastic lymphoma recurrent/refractory childhood Hodgkin lymphoma childhood chronic myelogenous leukemia |
Juvenile myelomonocytic leukemia Melphalan Leukemia, Lymphoid Cyclosporine Hodgkin's disease Hematologic Neoplasms Chronic myelogenous leukemia Clotrimazole Miconazole Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid, Acute Cyclosporins Small non-cleaved cell lymphoma Lymphoma, large-cell Leukemia |
Methotrexate Hodgkin Disease Lymphoma Acute myelocytic leukemia Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Tioconazole Acute myelogenous leukemia Fludarabine monophosphate Leukemia, Myelomonocytic, Juvenile Leukemia, Myeloid Lymphoblastic lymphoma Recurrence Folic Acid |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Reproductive Control Agents |
Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Neoplasms Antifungal Agents Therapeutic Uses Abortifacient Agents Antirheumatic Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors |