Clinical Trial: Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Study of Sunitinib in Patients With Refractory or Relapsed Germ Cell Tumors
Brief Summary:
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with metastatic germ cell tumors that have relapsed or not responded to treatment.
Detailed Summary:
OBJECTIVES:
Primary
- Determine the efficacy of sunitinib malate in patients with refractory or relapsed metastatic germ cell tumors.
Secondary
- Determine the safety of this drug in these patients.
- Determine the time to tumor response and duration of tumor response in patients treated with this drug.
OUTLINE: This is a open-label study.
Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed at 28 days and then periodically thereafter.
Sponsor: Memorial Sloan Kettering Cancer Center
Current Primary Outcome: Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment [ Time Frame: 2 years ]
Original Primary Outcome: Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment
Current Secondary Outcome:
Original Secondary Outcome:
- Time to tumor response
- Toxicity
- Duration of response
- Frequency of grade III and IV adverse events
Information By: Memorial Sloan Kettering Cancer Center
Dates:
Date Received: March 27, 2007
Date Started: March 2007
Date Completion:
Last Updated: September 24, 2015
Last Verified: September 2015
