Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment
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|ClinicalTrials.gov Identifier: NCT00453310|
Recruitment Status : Completed
First Posted : March 28, 2007
Results First Posted : October 27, 2015
Last Update Posted : October 27, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Extragonadal Germ Cell Tumor Ovarian Cancer Teratoma Testicular Germ Cell Tumor||Drug: sunitinib malate||Phase 2|
- Determine the efficacy of sunitinib malate in patients with refractory or relapsed metastatic germ cell tumors.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Sunitinib in Patients With Refractory or Relapsed Germ Cell Tumors|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
Experimental: sunitinib malate
The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)
Drug: sunitinib malate
- Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00453310
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Principal Investigator:||Dean F. Bajorin, MD||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Robert J. Motzer, MD||Memorial Sloan Kettering Cancer Center|