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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006019 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of phenylbutyrate plus azacitidine in treating patients who have acute myeloid leukemia, myelodysplasia, non-Hodgkin's lymphoma, multiple myeloma, non-small cell lung cancer, or prostate cancer.
Condition | Intervention | Phase |
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Leukemia Lung Cancer Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Prostate Cancer |
Drug: azacitidine Drug: sodium phenylbutyrate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Pilot Study of Sodium Phenylbutyrate Plus Azacytidine |
Study Start Date: | May 2000 |
OBJECTIVES:
OUTLINE: Patients receive azacytidine subcutaneously on days 1-7 and phenylbutyrate IV over 1-2 hours on days 8-12. Patients with acute myeloid leukemia who respond to therapy may receive a second course approximately 10 days after the end of the first. Subsequent courses in these patients, and all additional courses in all other patients, are repeated every 21 to 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following neoplastic diseases:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Patients without leukemia or myeloma:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Patients without leukemia:
Endocrine therapy:
Radiotherapy:
Patients without leukemia:
Surgery:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Peter Maslak, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000068030, MSKCC-99060, NCI-T99-0091 |
Study First Received: | July 5, 2000 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00006019 |
Health Authority: | United States: Federal Government |
recurrent non-small cell lung cancer refractory multiple myeloma recurrent adult acute myeloid leukemia recurrent prostate cancer adult acute myeloblastic leukemia without maturation (M1) adult acute myeloblastic leukemia with maturation (M2) adult acute promyelocytic leukemia (M3) adult acute myelomonocytic leukemia (M4) adult acute monoblastic leukemia (M5a) recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma |
recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma adult acute monocytic leukemia (M5b) previously treated myelodysplastic syndromes secondary myelodysplastic syndromes recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
Thoracic Neoplasms Prostatic Diseases Lymphoma, small cleaved-cell, diffuse Urogenital Neoplasms Preleukemia Hemorrhagic Disorders Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell Lung Neoplasms Azacitidine Leukemia, Promyelocytic, Acute Neoplasm Metastasis Acute myeloid leukemia, adult Chronic lymphocytic leukemia Myelodysplastic syndromes |
Lymphoma, Large B-Cell, Diffuse Non-small cell lung cancer Immunoproliferative Disorders 4-phenylbutyric acid Hematologic Diseases Leukemia, B-cell, chronic Blood Coagulation Disorders Acute promyelocytic leukemia Acute myelogenous leukemia Leukemia, Myeloid Genital Diseases, Male Carcinoma Multiple Myeloma B-cell lymphomas Lung Diseases |
Antimetabolites Respiratory Tract Neoplasms Neoplasms by Histologic Type Disease Antimetabolites, Antineoplastic Immune System Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Enzyme Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Pathologic Processes Therapeutic Uses Syndrome Cardiovascular Diseases |