ABT-510 and Bevacizumab in Treating Patients With Advanced Solid Tumors
Summary
RATIONALE: ABT-510 and bevacizumab may stop the growth of solid tumors by blocking blood flow to the tumor. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Giving ABT-510 together with bevacizumab may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of ABT-510 and bevacizumab in treating patients with advanced solid tumors.
Description
OBJECTIVES:
Primary
- Determine the recommended phase II dose for the combination of ABT-510 plus bevacizumab in patients with advanced solid tumors.
- Evaluate dose-limiting toxicities and non dose-limiting toxicities of this combination.
Secondary
- Collect preliminary data on the clinical activity of this combination (tumor response rate, progression-free survival, and rate of stable disease > 6 months).
OUTLINE: This is a dose-escalation study. Patients are sequentially enrolled with the first 9-18 patients assigned to part 1 and the next 20 patients assigned to part 2 of the study.
- Part 1: Patients receive ABT-510 subcutaneously (SC) twice daily on days 1-28 and bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of patients receive escalating doses of ABT-510 and bevacizumab until the recommended phase II dose is determined. Patients in part 2 are treated at the recommenced phase II dose.
- Part 2: The first 10 patients are assigned to group 1. The next 10 patients are assigned to group 2.
- Group 1: Patients receive ABT-510 SC twice daily beginning on day 1 and bevacizumab IV once every 14 days beginning on day 15.
- Group 2: Patients receive ABT-510 SC twice daily beginning on day 15 and bevacizumab IV once every 14 days beginning on day 1.
In both groups, treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study.
Study Design
Primary Purpose: Treatment
Conditions
Unspecified Adult Solid Tumor, Protocol Specific
Intervention
bevacizumab, ABT-510
Location
Duke Comprehensive Cancer Center
Durham
North Carolina
United States
27710
Status
Active, not recruiting
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00276562
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Nephroma, Mesoblastic
A solid, unencapsulated tumor of the KIDNEY composed of spindle mesenchymal cells that resemble FIBROBLASTS or muscle cells. The homogeneous mass typically extends into the renal parenchyma and replaces most of the kidney. In most cases, mesoblastic nephroma is benign and occurs in the fetus or newborn, and rarely in the older child or the adult.
Carcinoma, Ehrlich Tumor
A transplantable, poorly differentiated malignant tumor which appeared originally as a spontaneous breast carcinoma in a mouse. It grows in both solid and ascitic forms.
Cystadenocarcinoma, Mucinous
A malignant cystic or semisolid tumor most often occurring in the ovary. Rarely, one is solid. This tumor may develop from a mucinous cystadenoma, or it may be malignant at the onset. The cysts are lined with tall columnar epithelial cells; in others, the epithelium consists of many layers of cells that have lost normal structure entirely. In the more undifferentiated tumors, one may see sheets and nests of tumor cells that have very little resemblance to the parent structure. (Hughes, Obstetric-Gynecologic Terminology, 1972, p184)
Mastocytoma
A solid tumor consisting of a dense infiltration of MAST CELLS. It is generally benign.
Placebos
Any dummy medication or treatment. Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol.
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