SU5416 in Treating Patients With Advanced Solid Tumors
RATIONALE: SU5416 may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase I trial to study the effectiveness of SU5416 in treating patients who have advanced solid tumors.
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: semaxanib||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase I Pharmacodynamic Trial of SU5416 (NSC 696819)|
- Determine the maximum target-inhibiting dose of SU5416 in patients with advanced solid tumors. [ Time Frame: 1 hour twice weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients followed every 3 months. ]
|Study Start Date:||May 2000|
|Study Completion Date:||November 2005|
|Primary Completion Date:||December 2002 (Final data collection date for primary outcome measure)|
- Sugen 5416
OBJECTIVES: I. Determine the maximum target-inhibiting dose of SU5416 in patients with advanced solid tumors. II. Determine the relationship between dose or plasma levels and the clinical safety profile and antitumor effects of this treatment regimen in terms of objective response, stabilization of disease, or progression-free survival in this patient population. III. Evaluate the relationship between dose or plasma levels of SU5416 concentrations and the ability of this treatment regimen to reduce microvessel density and induce apoptosis of endothelial and tumor cells in this patient population. IV. Determine prognostic and surrogate serologic markers in these patients treated with this regimen. V. Determine if pre and posttreatment plasma and serum levels of angiogenic growth factors, basic fibroblast growth factor, and vascular endothelial cell growth factor are prognostic in predicting patient response to this regimen. VI. Determine if elevated plasma levels of endothelial cell specific proteins reflective of SU5416-induced endothelial damage and/or apoptosis are useful surrogate markers in assessing response to this treatment regimen in these patients.
OUTLINE: This is a dose-deescalation study. Patients receive SU5416 IV over 1 hour twice weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 6-12 patients receive deescalating doses of SU5416 until the maximum target-inhibiting dose (MTID) is determined. The MTID is defined as the dose at which patients experience no greater than grade 1 toxicity. Patients are followed every 3 months.
PROJECTED ACCRUAL: Approximately 20-30 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005642
|United States, Ohio|
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Principal Investigator:||Afshin Dowlati, MD||Ireland Cancer Center|