Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005804 |
RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating patients who have hematologic cancer.
Condition | Intervention | Phase |
---|---|---|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Precancerous/Nonmalignant Condition Small Intestine Cancer |
Drug: cyclophosphamide Procedure: allogeneic bone marrow transplantation Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Treatment of Patients With Hematological Malignancies Using Marrow Transplantation From Unrelated Donors Incompatible for One HLA Locus Antigen |
Study Start Date: | October 1999 |
OBJECTIVES:
OUTLINE: Beginning at least 3 weeks after completion of cytoreductive combination chemotherapy, patients under age 18 undergo total body irradiation (TBI) twice a day on days -7 to -4. Patients age 18 and over undergo TBI twice a day on days -6 to -4. All patients then receive cyclophosphamide IV daily on days -3 and -2. Males with acute lymphocytic leukemia, high-grade lymphoma, intermediate-grade lymphoma, or marrow or CNS involvement receive radiotherapy boost to the testes. On day 0, patients receive infusion of bone marrow from unrelated donors with 1 of the following: 1 HLA-A or B non-cross-reactive group mismatch; 1 HLA-A or B cross-reactive group mismatch; or an HLA-A, B, and C match with an HLA-DRB1 or DQB1 mismatch.
Patients are followed every 6 months for 2 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 5 years.
Ages Eligible for Study: | up to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven hematologic malignancy of 1 of the following types:
Acute leukemia with high-risk features at diagnosis such as:
NOTE: ** For newly diagnosed patients with high-risk acute leukemia, early referral is encouraged so that an unrelated donor search may begin immediately
Availability of an unrelated donor with:
An HLA-A, B, and C match with an HLA-DRB1 or DQB1 mismatch (no double mismatch) if 1 of the above 2 donor types unavailable
No availability of an HLA-identical sibling or haploidentical relative incompatible for 0 or 1 HLA-A or B locus of the nonshared haplotypes
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Washington | |
Fred Hutchinson Cancer Research Center | |
Seattle, Washington, United States, 98109-1024 |
Study Chair: | Claudio Anasetti, MD | Fred Hutchinson Cancer Research Center |
Study ID Numbers: | CDR0000067780, FHCRC-1467.00, NCI-H00-0054 |
Study First Received: | June 2, 2000 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00005804 |
Health Authority: | United States: Federal Government |
monoclonal gammopathy of undetermined significance recurrent childhood acute lymphoblastic leukemia recurrent adult Hodgkin lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma Burkitt lymphoma isolated plasmacytoma of bone extramedullary plasmacytoma refractory multiple myeloma Waldenstrom macroglobulinemia stage III multiple myeloma stage II childhood lymphoblastic lymphoma stage III childhood lymphoblastic lymphoma stage IV childhood lymphoblastic lymphoma recurrent childhood lymphoblastic lymphoma recurrent childhood acute myeloid leukemia |
recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia small intestine lymphoma childhood immunoblastic large cell lymphoma chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia untreated adult acute lymphoblastic leukemia untreated adult acute myeloid leukemia untreated childhood acute myeloid leukemia and other myeloid malignancies untreated childhood acute lymphoblastic leukemia adult acute myeloid leukemia in remission adult acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission childhood acute lymphoblastic leukemia in remission |
Blast Crisis Sezary syndrome Chronic myelogenous leukemia Hodgkin lymphoma, adult Lymphoma, small cleaved-cell, diffuse Small non-cleaved cell lymphoma Ileal Diseases Lymphoma, large-cell, immunoblastic Preleukemia Leukemia, Prolymphocytic Hemorrhagic Disorders Hemorrhagic thrombocythemia Lymphoma, Large-Cell, Anaplastic Neoplasm Metastasis Thrombocythemia, Hemorrhagic |
Myelodysplastic syndromes Essential thrombocytosis Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders Acute myelogenous leukemia Leukemia, Myeloid Waldenstrom Macroglobulinemia Plasmacytoma Leukemia, Myeloid, Accelerated Phase B-cell lymphomas Anaplastic large cell lymphoma Lymphoma, Non-Hodgkin Hairy cell leukemia |
Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions Neoplasms |
Pathologic Processes Neoplasms by Site Jejunal Diseases Therapeutic Uses Syndrome Myeloablative Agonists Cardiovascular Diseases Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |