Tandutinib in Treating Patients Who Have Undergone Surgery for Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma
Recurrent Renal Cell Cancer
Stage IV Renal Cell Cancer
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of MLN518 in Patients With Metastatic Clear Cell Renal Cell Carcinoma|
- Overall Efficacy, Taking Into Account Both Objective Response and Meaningful Reductions in Tumor Burden That do Not Meet the RECIST Criteria for PR or CR (e.g., 5-30% Reduction in RECIST Defined Tumor Burden) [ Time Frame: Up to 4 weeks after completion of study treatment ] [ Designated as safety issue: No ]The number of patients that reach complete response (CR)defined as the disappearance of all target lesions or partial response (PR)defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
- Overall Survival [ Time Frame: Up to 4 weeks after completion of study treatment ] [ Designated as safety issue: No ]Estimated using the method of Kaplan and Meier.
- Progression-free Survival [ Time Frame: Up to 4 weeks after completion of study treatment ] [ Designated as safety issue: No ]Estimated time to progression using the method of Kaplan and Meier.
|Study Start Date:||November 2006|
|Study Completion Date:||December 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Given orally, 500 mg bid daily
Other Names:Other: laboratory biomarker analysis
I. To determine the overall efficacy of MLN518 in patients with metastatic clear cell renal carcinoma.
I. To evaluate the effect of MLN518 on progression-free survival and overall survival in patients with metastatic clear cell renal carcinoma.
II. To evaluate the toxicity of MLN518 in patients with metastatic clear cell renal carcinoma.
III. To evaluate the effects of MLN518 on serum VEGF-A, VEGF-R2, PIGF, and PDGF levels of patients with metastatic renal cell carcinoma receiving MLN518.
IV. To determine the VHL gene status, methylation, and pVHL in archived material from the primary nephrectomy specimen of patients receiving MLN518.
V. To evaluate tumor blood flow and vessel permeability based on functional imaging with dynamic contrast enhanced magnetic resonance imaging (dceMRI) in metastatic renal cell carcinoma patients treated with MLN518.
OUTLINE: This is an open-label, nonrandomized study.
Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00408902
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Jorge Garcia||Case Comprehensive Cancer Center|