Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Respond… (NCT00453310) | Clinical Trial Compass
CompletedPhase 2
Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to Treatment
United States10 participantsStarted 2007-03
Plain-language 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.
Who can participate
Age range18 Years – 120 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed seminoma or nonseminoma germ cell tumors (GCT)
* Refractory or relapsed disease
* Metastatic disease
* Progressive disease after prior cisplatin-based chemotherapy AND meets 1 of the following criteria for salvage therapy:
* Not a candidate for potentially curative therapy
* Received prior high-dose chemotherapy regimens
* Declines potentially curative therapy (mediastinal GCT or primary refractory GCT)
* Measurable disease\*, defined as 1 of the following:
* At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
* Elevation of alpha-fetoprotein \> 15 ng/mL and/or elevation of human chorionic gonadotropin \> 2.2 mIU/L
* NOTE: \*Patients with radiographically measurable disease only must have ≥ 1 site that has not undergone prior irradiation
PATIENT CHARACTERISTICS:
* Karnofsky performance status 70-100%
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 9.0 g/dL
* Creatinine ≤ 1.5 times upper limit of normal (ULN)
* Bilirubin ≤ 1.5 times ULN
* AST and ALT ≤ 2.5 times ULN (unless elevated liver function abnormalities due to underlying malignancy)
* LVEF ≥ 50% by MUGA
* No grade 3 hemorrhage within the past 4 weeks
* None of the following within the past 6 months:
* Myocardial infarction
* Severe or unstable angina
* Coronary or peripheral artery bypass graft
* Symptomatic congestive heart failure
* Cerebrov…
What they're measuring
1
Confirmed Objective Response Rate (Complete and Partial Response) as Measured by RECIST Criteria After 2 Courses of Treatment