Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT00408902
Status:
COMPLETED
Last Update Posted:
2017-11-22
First Post:
2006-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Tandutinib in Treating Patients Who Have Undergone Surgery for Metastatic Kidney Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Phase II Study of MLN518 in Patients With Metastatic Clear Cell Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2017-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial is studying how well tandutinib works in treating patients who have undergone surgery for metastatic kidney cancer. Tandutinib may stop the growth of kidney cancer by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving tandutinib after surgery may kill any tumor cells that remain after surgery.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the overall efficacy of MLN518 in patients with metastatic clear cell renal carcinoma.
SECONDARY OBJECTIVES:
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.
I. To determine the overall efficacy of MLN518 in patients with metastatic clear cell renal carcinoma.
SECONDARY OBJECTIVES:
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CASE 10805 | None | None | View | |
| CDR0000518799 | None | None | View | |
| U01CA062502 | NIH | None | https://reporter.nih.gov/quic… | View |