Track topics on Twitter Track topics that are important to you
RATIONALE: GSAO may stop the growth of solid tumors by blocking blood flow to the tumor.
PURPOSE: This phase I trial is studying the side effects and best dose of GSAO in treating patients with advanced solid tumors that have not responded to therapy.
- To determine the maximum-tolerated dose and recommended phase II dose of angiogenesis inhibitor GSAO in patients with advanced, refractory solid tumors.
- To assess the safety and toxicity profile and dose-limiting toxicity of this drug in these patients.
- To determine the pharmacokinetics of this drug in these patients.
- To determine the pharmacodynamics of this drug in these patients.
- To determine possible anti-tumor activity in patients treatment with this drug.
- To further determine the pharmacodynamics of this drug in these patients.
OUTLINE: This is a multicenter, dose-escalation study.
Patients receive angiogenesis inhibitor GSAO IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients showing clinical benefit (i.e., stable disease, partial response, or complete response) may receive 6 additional courses of treatment. Patients receive angiogenesis inhibitor GSAO IV over 1 hour on day -7 to obtain pharmacokinetics information of a single IV dose of the drug.
Patients also undergo dynamic contrast-enhanced magnetic-resonance imaging (DCE-MRI) prior to, during, and after study to determine blood flow parameters.
Blood samples are collected periodically for pharmacokinetic, pharmacodynamic, and biomarker studies.
After completion of study treatment, patients are followed up for 28 days and then once a month thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
Primary Purpose: Treatment
Unspecified Adult Solid Tumor, Protocol Specific
angiogenesis inhibitor GSAO, laboratory biomarker analysis, pharmacological study, dynamic contrast-enhanced magnetic resonance imaging
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:12:48-0400
This phase 0/I trial studies the side effects and best dose of MDM2 inhibitor AMG-232 in treating patients with glioblastoma that is newly diagnosed or has come back. MDM2 inhibitor AMG-23...
This phase II trial studies how well HIF-2 alpha inhibitor PT2385 works in treating patients with recurrent glioblastoma. HIF-2 alpha inhibitor PT2385 may stop the growth of tumor cells by...
This phase II trial is studying how well Akt inhibitor MK2206 works in treating patients with relapsed or refractory diffuse large B-cell lymphoma. Akt inhibitor MK2206 may stop the growth...
This phase I trial studies the side effects and the best dose of lapatinib ditosylate and Akt inhibitor MK2206 in treating women with metastatic breast cancer. Lapatinib ditosylate and Akt...
This randomized phase I trial studies the side effects and best dose of dinaciclib and Akt inhibitor MK2206 in treating patients with pancreatic cancer that cannot be removed by surgery. D...
Existing animal models for screening tumor angiogenic process have various setbacks that necessitate further investigations. In this study, we developed an ex-ovo egg yolk angiogenesis model to screen...
The aim of the present work was to study the prevention of liver cancer angiogenesis via miR-126. For this purpose, experimentations were conducted.
α-defensin is a biomarker which has been described as having a high degree of accuracy in the diagnosis of periprosthetic joint infection (PJI). Current meta-analyses are based on the α-defensin lab...
Zinc (Zn) is a micronutrient and essential element of life and its deficiency causes severe disorders of numerous body systems, such as immune, reproductive and central nervous system. Zinc supplement...
Anti-angiogenesis therapy is an established therapeutic strategy for cancer. The endogenous angiogenic inhibitor angiostatin contains the first 3-4 kringle domains of plasminogen and inhibits both ang...
Techniques which study entities using their topological, geometric, or geographic properties and include the dimension of time in the analysis.
A type of analysis in which subjects in a study group and a comparison group are made comparable with respect to extraneous factors by individually pairing study subjects with the comparison group subjects (e.g., age-matched controls).
Absolute, comparative, or differential costs pertaining to services, institutions, resources, etc., or the analysis and study of these costs.
A set of techniques used when variation in several variables has to be studied simultaneously. In statistics, multivariate analysis is interpreted as any analytic method that allows simultaneous study of two or more dependent variables.
Statistical models used in survival analysis that assert that the effect of the study factors on the hazard rate in the study population is multiplicative and does not change over time.
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...