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Sponsors and Collaborators: |
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00769288 |
RATIONALE: Drugs used in chemotherapy, such as FAU, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase I trial is studying the side effects and best dose of FAU in treating patients with advanced solid tumors or lymphoma.
Condition | Intervention | Phase |
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Lymphoma Small Intestine Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: FAU Genetic: gene expression analysis Genetic: polymerase chain reaction Genetic: polymorphism analysis Genetic: protein expression analysis Genetic: western blotting Other: high performance liquid chromatography Other: immunohistochemistry staining method Other: laboratory biomarker analysis Other: mass spectrometry Other: pharmacogenomic studies Other: pharmacological study Procedure: positron emission tomography |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study of Intravenously Administered FAU (1-(2'-Deoxy-2'-Fluoro-β-D-Arabinofuranosyl) Uracil, NSC# 678515) in Patients With Advanced Solid Tumors |
Estimated Enrollment: | 49 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive FAU IV over 1 hour on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and urine samples are collected periodically for pharmacokinetic studies using high performance liquid chromatography with tandem mass spectrometry. Archival tumor tissue samples are obtained for pharmacodynamic and pharmacogenomic studies, including analysis of thymidylate synthase (TS) polymorphisms by PCR and polyacrylamide gel electrophoresis and analysis of TS expression by IHC. Patients treated with FAU at the maximum tolerated dose also undergo tumor tissue biopsies for additional pharmacodynamic studies, including analysis of thymidine kinase (TK) and TS expression (protein and mRNA expression) by western blotting and PCR and analysis of TK and TS enzyme activity by assay.
Patients undergo PET imaging with ^18F-FAU at baseline and on day 1 of course 1 (after the first infusion of unlabeled FAU) for correlative imaging studies.
After completion of study therapy, patients are followed for 30 days.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed malignant solid tumor for which standard curative or palliative measures do not exist or are no longer effective
No known active brain metastases
PATIENT CHARACTERISTICS:
No uncontrolled illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No other concurrent anticancer therapy (e.g., cytotoxic therapy, biologic therapy, radiotherapy, or hormonal therapy)
Study ID Numbers: | CDR0000615651, WSU-2007-005 |
Study First Received: | October 8, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00769288 History of Changes |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific recurrent adult T-cell leukemia/lymphoma stage III adult T-cell leukemia/lymphoma stage IV adult T-cell leukemia/lymphoma adult grade III lymphomatoid granulomatosis adult nasal type extranodal NK/T-cell lymphoma anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma splenic marginal zone lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma stage III adult Burkitt lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma |
stage III adult Hodgkin lymphoma stage III adult immunoblastic large cell lymphoma stage III adult lymphoblastic lymphoma stage III cutaneous T-cell non-Hodgkin lymphoma stage III mycosis fungoides/Sezary syndrome stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage III mantle cell lymphoma stage III marginal zone lymphoma stage III small lymphocytic lymphoma stage IV adult Burkitt lymphoma stage IV adult diffuse large cell lymphoma stage IV adult diffuse mixed cell lymphoma stage IV adult diffuse small cleaved cell lymphoma |
Lymphoma, Mantle-Cell Mantle Cell Lymphoma Ileal Diseases Follicular Lymphoma Duodenal Neoplasms Mycoses Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, Large-Cell, Anaplastic Hodgkin Disease Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Digestive System Neoplasms Waldenstrom Macroglobulinemia B-cell Lymphomas Leukemia, T-Cell |
Gastrointestinal Neoplasms Lymphoma, Non-Hodgkin Lymphoma, T-Cell, Cutaneous Gastrointestinal Diseases Lymphoma, Follicular Lymphoma, B-Cell, Marginal Zone Sezary Syndrome Mycosis Fungoides Lymphoblastic Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, B-Cell Lymphoma, Small Cleaved-cell, Diffuse Leukemia Ileal Neoplasms Cutaneous T-cell Lymphoma |
Jejunal Neoplasms Digestive System Neoplasms Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Gastrointestinal Diseases Intestinal Diseases Ileal Diseases Intestinal Neoplasms Duodenal Neoplasms Lymphatic Diseases |
Neoplasms Digestive System Diseases Neoplasms by Site Ileal Neoplasms Jejunal Diseases Gastrointestinal Neoplasms Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma Duodenal Diseases |