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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00810966 |
Purpose
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: cyclophosphamide Drug: veliparib Other: immunologic technique Other: laboratory biomarker analysis Other: liquid chromatography Other: mass spectrometry Other: pharmacological study |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Study of ABT-888 in Combination With Metronomic Cyclophosphamide in Adults With Refractory Solid Tumors and Lymphomas |
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2008 |
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.
Eligibility| 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:
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033 | |
| City of Hope Medical Group | |
| Pasadena, California, United States, 91105 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
| Bethesda, Maryland, United States, 20892-1182 | |
| United States, Pennsylvania | |
| Penn State Hershey Cancer Institute at Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| UPMC Cancer Center at Magee-Womens Hospital | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Principal Investigator: | Shivaani Kummar, MD | NCI - Developmental Therapeutics Clinic |
More Information
| ClinicalTrials.gov Identifier: | NCT00810966 History of Changes |
| Other Study ID Numbers: | 090048, CDR0000629899, NCI-09-C-0048, P8437 |
| Study First Received: | December 17, 2008 |
| Last Updated: | September 29, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
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 |
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Leukemia Lymphoma Lymphoma, Non-Hodgkin Lymphoma, Large-Cell, Immunoblastic Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |