Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Cancer Research UK Phase I Trial of 4-(N-(S-Glutathionylacetyl) Amino) Phenylarsenoxide (GSAO) Given as Daily Intravenous Infusions on Days 1-5 and 8-12 of a 21-Day Cycle, to Patients With Advanced Solid Tumors
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.
OBJECTIVES:
Primary
- 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.
Secondary
- 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.
Tertiary
- 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
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