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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: | NCT00042900 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of pyroxamide in treating patients who have advanced cancer.
Condition | Intervention | Phase |
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Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Precancerous/Nonmalignant Condition Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: pyroxamide |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Clinical And Pharmacological Study Of Pyroxamide (NSC 696085) In Patients With Advanced Malignancies |
Study Start Date: | April 2002 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study.
Patients receive pyroxamide IV continuously over 5-7 days. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of pyroxamide until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
Patients are followed monthly for resolution of adverse events.
PROJECTED ACCRUAL: A maximum of 32 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:
Histologically or cytologically confirmed solid tumor or hematologic malignancy
Measurable or clinically evaluable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Leonard B. Saltz, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000069483, MSKCC-99090, NCI-2110 |
Study First Received: | August 5, 2002 |
Last Updated: | November 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00042900 History of Changes |
Health Authority: | United States: Federal Government |
AIDS-related peripheral/systemic lymphoma AIDS-related primary CNS lymphoma T-cell large granular lymphocyte leukemia Waldenstrom macroglobulinemia accelerated phase chronic myelogenous leukemia acute undifferentiated leukemia adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission chronic idiopathic myelofibrosis anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma blastic phase chronic myelogenous leukemia chronic myelomonocytic leukemia chronic phase chronic myelogenous leukemia de novo myelodysplastic syndromes |
essential thrombocythemia extramedullary plasmacytoma intraocular lymphoma isolated plasmacytoma of bone meningeal chronic myelogenous leukemia monoclonal gammopathy of undetermined significance polycythemia vera previously treated myelodysplastic syndromes primary central nervous system lymphoma primary systemic amyloidosis progressive hairy cell leukemia, initial treatment prolymphocytic leukemia recurrent adult Hodgkin lymphoma recurrent adult T-cell leukemia/lymphoma recurrent adult acute lymphoblastic leukemia |
Blast Crisis Mantle Cell Lymphoma Ileal Diseases Preleukemia Leukemia, Prolymphocytic Hemorrhagic Disorders Lymphoma, Large-Cell, Anaplastic Neoplasm Metastasis Thrombocythemia, Hemorrhagic Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders Leukemia, Myeloid Waldenstrom Macroglobulinemia |
Plasmacytoma Leukemia, Myeloid, Accelerated Phase Chronic Myelogenous Leukemia Lymphoma, Non-Hodgkin Precancerous Conditions Blood Protein Disorders Lymphoma, Follicular Sezary Syndrome Lymphoblastic Lymphoma Lymphoma, B-Cell Leukemia Ileal Neoplasms Cutaneous T-cell Lymphoma Lymphoma, T-Cell Duodenal Diseases |
Precancerous Conditions Gastrointestinal Diseases Blood Protein Disorders Paraproteinemias Hemostatic Disorders Ileal Diseases Duodenal Neoplasms Leukemia Preleukemia Neoplasms by Site Pathologic Processes Hemorrhagic Disorders Ileal Neoplasms Jejunal Diseases Syndrome |
Cardiovascular Diseases Lymphoma Duodenal Diseases Jejunal Neoplasms Digestive System Neoplasms Disease Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Vascular Diseases Intestinal Diseases Intestinal Neoplasms |