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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00020592 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine after the transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying how well combination chemothearpy, low-dose chemotherapy, and allogeneic stem cell transplant work in treating children with hematologic cancers.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: cyclophosphamide Drug: cyclosporine Drug: cytarabine Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: fludarabine phosphate Drug: methotrexate Drug: prednisone Drug: therapeutic allogeneic lymphocytes Drug: vincristine sulfate Procedure: allogeneic hematopoietic stem cell transplantation Procedure: peripheral blood stem cell transplantation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Pilot Study Of Non-Myeloablative, HLA-Matched Allogeneic Stem Cell Transplantation For Pediatric Hematopoietic Malignancies |
Estimated Enrollment: | 56 |
Study Start Date: | March 2001 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 4 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Hodgkin's lymphoma or non-Hodgkin's lymphoma, meeting 1 of the following criteria:
Acute myelogenous leukemia
Acute lymphoblastic leukemia, meeting 1 of the following criteria:
Acute hybrid leukemia including mixed lineage, biphenotypic, and undifferentiated, meeting 1 of the following criteria:
Myelodysplastic syndromes
Chronic myelogenous leukemia, meeting 1 of the following criteria:
Juvenile myelomonocytic leukemia
No active CNS malignancy
Donor criteria:
5 or 6 antigen HLA-matched first-degree related 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:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Study Chair: | Alan S. Wayne, MD | NCI - Pediatric Oncology Branch |
Study ID Numbers: | CDR0000068621, NCI-01-C-0125F |
Study First Received: | July 11, 2001 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00020592 |
Health Authority: | Unspecified |
recurrent childhood lymphoblastic lymphoma chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia childhood acute myeloid leukemia in remission childhood acute lymphoblastic leukemia in remission recurrent/refractory childhood Hodgkin lymphoma acute undifferentiated leukemia secondary myelodysplastic syndromes recurrent childhood small noncleaved cell lymphoma |
recurrent childhood large cell lymphoma juvenile myelomonocytic leukemia childhood chronic myelogenous leukemia atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable de novo myelodysplastic syndromes previously treated myelodysplastic syndromes chronic myelomonocytic leukemia childhood myelodysplastic syndromes |
Juvenile myelomonocytic leukemia Prednisone Cyclosporine Chronic myelogenous leukemia Chronic myelomonocytic leukemia Miconazole Cyclosporins Small non-cleaved cell lymphoma Preleukemia Neoplasm Metastasis Methotrexate Etoposide Hodgkin Disease Myelodysplastic syndromes Lymphoma, Large B-Cell, Diffuse |
Immunoproliferative Disorders Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Myeloproliferative Disorders Acute myelogenous leukemia Vincristine Leukemia, Myeloid Doxorubicin Folic Acid Myelodysplastic myeloproliferative disease Leukemia, Myeloid, Accelerated Phase Hodgkin lymphoma, childhood Fludarabine |
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Antibiotics, Antineoplastic Hormones Neoplasms by Site Pathologic Processes Therapeutic Uses |
Syndrome Antifungal Agents Abortifacient Agents Alkylating Agents Dermatologic Agents Nucleic Acid Synthesis Inhibitors Disease Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal |