Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00014469 |
RATIONALE: 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 cancer cells.
PURPOSE: Phase II trial to study the effectiveness of busulfan and melphalan followed by donor bone marrow transplantation in treating patients who have advanced hematologic cancer.
Condition | Intervention | Phase |
---|---|---|
Graft Versus Host Disease Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: busulfan Drug: melphalan Drug: methotrexate Drug: tacrolimus Procedure: allogeneic bone marrow transplantation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial of IV Busulfan (Busulfex) and Melphalan as a Preparatory Regimen Prior to Allogeneic Bone Marrow Transplantation for the Treatment of Advanced and High Risk Hematologic Malignancies |
Study Start Date: | December 2000 |
OBJECTIVES:
OUTLINE: Patients receive cytoreductive chemotherapy comprising busulfan IV over 2 hours every 6 hours for a total of 16 doses on days -8 to -5 and melphalan IV over 30 minutes on days -4 to -2. Patients undergo T-cell replete allogeneic bone marrow transplantation on day 0. For graft-versus-host disease prophylaxis, patients receive tacrolimus IV continuously or every 12 hours beginning on day -1 and continuing for 50 days to 6 months followed by a taper. Once oral medications are tolerated, patients switch to oral tacrolimus every 12 hours. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
Patients are followed weekly through day 100, every 6 weeks for 3 months, every 3 months for 1 year, and then every 3-6 months for 6 months.
PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 3 years.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following:
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, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Trudy N. Small, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000068546, MSKCC-00126, NCI-H01-0070 |
Study First Received: | April 10, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00014469 |
Health Authority: | United States: Federal Government |
recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous 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 refractory anemia with excess blasts refractory anemia with excess blasts in transformation |
chronic myelomonocytic leukemia acute undifferentiated leukemia secondary acute myeloid leukemia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes graft versus host disease refractory cytopenia with multilineage dysplasia juvenile myelomonocytic leukemia childhood chronic myelogenous leukemia atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with inv(16)(p13;q22) |
Juvenile myelomonocytic leukemia Melphalan Blast Crisis Leukemia, Lymphoid Chronic myelogenous leukemia Precancerous Conditions Hematologic Neoplasms Chronic myelomonocytic leukemia Refractory anemia Graft versus host disease Tacrolimus Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid, Acute Acute lymphoblastic leukemia, adult Leukemia |
Preleukemia Anemia, Refractory Leukemia, Lymphocytic, Chronic, B-Cell Neoplasm Metastasis Methotrexate Acute myeloid leukemia, adult Congenital Abnormalities Acute myelocytic leukemia Chronic lymphocytic leukemia Myelodysplastic syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, B-cell, chronic Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Reproductive Control Agents Pathologic Processes Syndrome Therapeutic Uses Abortifacient Agents Alkylating Agents Dermatologic Agents |
Nucleic Acid Synthesis Inhibitors Disease Neoplasms by Histologic Type Immune System Diseases Enzyme Inhibitors Abortifacient Agents, Nonsteroidal Folic Acid Antagonists Immunosuppressive Agents Pharmacologic Actions Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |