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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00810966 |
RATIONALE: ABT-888 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving ABT-888 together with cyclophosphamide may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of ABT-888 when given together with cyclophosphamide in treating patients with solid tumors or lymphoma that did not respond to previous therapy.
Condition | Intervention | Phase |
---|---|---|
Leukemia Lymphoma Unspecified Adult Solid Tumor, Protocol Specific |
Drug: ABT-888 Drug: cyclophosphamide Other: immunologic technique Other: laboratory biomarker analysis Other: liquid chromatography Other: mass spectrometry Other: pharmacological study |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label |
Official Title: | A Phase I Study of ABT-888 in Combination With Metronomic Cyclophosphamide in Adults With Refractory Solid Tumors and Lymphomas |
Estimated Enrollment: | 36 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of ABT-888.
Patients receive oral ABT-888 once daily for 7-21 days and oral cyclophosphamide once daily for 14 or 21 days.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Plasma samples are collected periodically for pharmacodynamic and pharmacokinetic analysis. Samples are analyzed for PAR concentration by immunoassay, γ-H2AX levels by immunocytochemistry, quantification of the γ-H2AX marker and co-localization markers via quantitative immunofluorescence analysis, and ABT-888 concentration by liquid chromatography/mass spectrometry.
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 confirmed solid tumor or lymphoid (e.g., lymphoma or chronic lymphocytic leukemia) malignancies
Refractory to standard therapy or no acceptable standard treatment options exists
No gliomas, symptomatic CNS metastases, or carcinomatous meningitis
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Robert J. Morgan, MD 626-256-4673 ext. 65928 rmorgan@coh.org | |
City of Hope Medical Group | Recruiting |
Pasadena, California, United States, 91105 | |
Contact: Mark V. McNamara, MD 626-396-2900 mmcnamara@ccsmg.com | |
University of California Davis Cancer Center | Recruiting |
Sacramento, California, United States, 95817 | |
Contact: David R. Gandara, MD 916-734-3700 david.gandara@ucdmc.ucdavis.edu | |
USC/Norris Comprehensive Cancer Center and Hospital | Recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Heinz-Josef Lenz, MD 323-865-3900 lenz_h@ccnt.usc.edu | |
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 | |
United States, Pennsylvania | |
Penn State Cancer Institute at Milton S. Hershey Medical Center | Recruiting |
Hershey, Pennsylvania, United States, 17033-0850 | |
Contact: Clinical Trials Office - Penn State Cancer Institute at Milton 717-531-3779 CTO@hmc.psu.edu | |
UPMC Cancer Centers | Recruiting |
Pittsburgh, Pennsylvania, United States, 15232 | |
Contact: Clinical Trials Office - UPMC Cancer Centers 412-647-8073 |
Principal Investigator: | Shivaani Kummar, MD | NCI - Medical Oncology Branch |
Study ID Numbers: | CDR0000629899, NCI-09-C-0048, P8437 |
Study First Received: | December 17, 2008 |
Last Updated: | August 11, 2009 |
ClinicalTrials.gov Identifier: | NCT00810966 History of Changes |
Health Authority: | Unspecified |
unspecified adult solid tumor, protocol specific recurrent adult T-cell leukemia/lymphoma recurrent adult Hodgkin lymphoma recurrent adult Burkitt lymphoma recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult grade III lymphomatoid granulomatosis recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent cutaneous T-cell non-Hodgkin lymphoma recurrent mycosis fungoides/Sezary syndrome recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma |
recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic lymphoma refractory chronic lymphocytic leukemia anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma adult nasal type extranodal NK/T-cell lymphoma Waldenstrom macroglobulinemia stage III adult T-cell leukemia/lymphoma stage IV adult T-cell leukemia/lymphoma stage III adult Hodgkin lymphoma stage IV adult Hodgkin lymphoma stage III adult Burkitt lymphoma stage IV adult Burkitt lymphoma stage III adult diffuse large cell lymphoma |
Leukemia, Lymphoid Immunologic Factors Lymphoma, Mantle-Cell Lymphoma, Follicular Mantle Cell Lymphoma Sezary Syndrome Lymphoma, B-Cell, Marginal Zone Cyclophosphamide Mycosis Fungoides Lymphoblastic Lymphoma Follicular Lymphoma Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Lymphoma, B-Cell Leukemia |
Mycoses Cutaneous T-cell Lymphoma Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, T-Cell Lymphoma, Large-Cell, Immunoblastic Lymphoma, Large-Cell, Anaplastic Lymphoma, Large-cell Leukemia, B-cell, Chronic Alkylating Agents Hodgkin Disease Lymphoma Lymphoma, Large B-Cell, Diffuse Lymphomatoid Granulomatosis Immunoproliferative Disorders Hodgkin Lymphoma, Adult |
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Immunosuppressive Agents Pharmacologic Actions Leukemia |
Lymphatic Diseases Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Alkylating Agents Lymphoma |