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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: | NCT00576654 |
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. ABT-888 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving irinotecan together with ABT-888 may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of irinotecan given together with ABT-888 in treating patients with metastatic or unresectable cancer.
Condition | Intervention | Phase |
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Lymphoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: ABT-888 Drug: irinotecan hydrochloride Procedure: biopsy Procedure: high performance liquid chromatography Procedure: immunoenzyme technique Procedure: laboratory biomarker analysis Procedure: pharmacological study Procedure: polymorphism analysis |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I Dose-Escalation Study of Oral ABT-888 (NSC #737664) Plus Intravenous Irinotecan (CPT-11, NSC#616348) Administered in Patients With Advanced Solid Tumors |
Estimated Enrollment: | 25 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
Tertiary
OUTLINE: This is a multicenter, dose-escalation of ABT-888 study.
Patients receive irinotecan hydrochloride IV over 90 minutes on days 1 and 8 and oral ABT-888 twice daily on days 0-14 (days 3-14 of course 1 only). Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood sample collection for pharmacokinetic and pharmacodynamic sampling periodically during courses 1 and 2. Samples are analyzed for topoisomerase I expression, polymorphism of ERCC1, PAR concentration by immunoassay, plasma concentrations of irinotecan hydrochloride and its metabolites by high performance liquid chromatography, and pharmacogenomics assessing polymorphisms in UGT1A1, CYP2C9, CYP2C19, and ABCG2. Patients also undergo tumor tissue biopsies periodically and samples are also analyzed for research studies.
After completion of study treatment, patients are followed periodically 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 metastatic or unresectable malignancy meeting 1 of the following criteria:
No known active brain metastases
PATIENT CHARACTERISTICS:
No history of allergic reactions attributed to the following:
No uncontrolled intercurrent illness including, but not limited to:
PRIOR CONCURRENT THERAPY:
Study ID Numbers: | CDR0000579642, WSU-2007-014 |
Study First Received: | December 18, 2007 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00576654 |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific recurrent adult Hodgkin lymphoma recurrent adult non-Hodgkin lymphoma stage III adult Hodgkin lymphoma stage III adult non-Hodgkin lymphoma stage IV adult Hodgkin lymphoma stage IV adult non-Hodgkin lymphoma recurrent adult T-cell leukemia/lymphoma stage III adult T-cell leukemia/lymphoma stage IV adult T-cell leukemia/lymphoma angioimmunoblastic T-cell lymphoma stage III mycosis fungoides/Sezary syndrome stage IV mycosis fungoides/Sezary syndrome recurrent mycosis fungoides/Sezary syndrome recurrent cutaneous T-cell non-Hodgkin lymphoma |
stage III cutaneous T-cell non-Hodgkin lymphoma stage IV cutaneous T-cell non-Hodgkin lymphoma recurrent adult grade III lymphomatoid granulomatosis adult nasal type extranodal NK/T-cell lymphoma Waldenstrom macroglobulinemia recurrent adult Burkitt lymphoma stage III adult Burkitt lymphoma stage IV adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma stage III adult diffuse large cell lymphoma stage III adult diffuse mixed cell lymphoma stage III adult diffuse small cleaved cell lymphoma stage IV adult diffuse large cell lymphoma |
Sezary syndrome Hodgkin's disease Hodgkin lymphoma, adult Cutaneous T-cell lymphoma Lymphoma, Mantle-Cell Irinotecan Lymphoma, small cleaved-cell, diffuse Lymphoma, Follicular Sezary Syndrome Lymphoma, B-Cell, Marginal Zone Mycosis Fungoides Lymphoma, large-cell, immunoblastic Lymphoma, large-cell Lymphoma, B-Cell Lymphomatoid granulomatosis |
Burkitt's lymphoma Leukemia Mycoses Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, T-Cell Lymphoma, Large-Cell, Immunoblastic Waldenstrom macroglobulinemia Hodgkin Disease Lymphoma Chronic lymphocytic leukemia Lymphoma, Large B-Cell, Diffuse Lymphomatoid Granulomatosis Immunoproliferative Disorders Leukemia, B-cell, chronic Leukemia-Lymphoma, Adult T-Cell |
Neoplasms Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |