Sunitinib Malate in Refractory Germ Cell Tumors
Condition: Genitourinary Disease
MeSH terms: Neoplasms, Germ Cell and Embryonal; Urogenital Diseases
Intervention: Sunitinib Malate
Intervention description: 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Genitourinary; Testis; Refractory Germ Cell Tumors; Advanced germ cell tumors; GCTs; Sunitinib Malate; Sutent; SU011248

Summary:

      The goal of this clinical research study is to learn if Sutent® (sunitinib malate, SU011248)
      can control the disease in patients with germ cell tumors that are resistant to earlier
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Progressive metastatic Germ-cell tumors (GCTs) of gonadal or extragonadal origin in
             males after failure of front-line therapy and at least one salvage regimen.

          2. Must have evaluable or measurable disease by clinical or radiological studies.
             Alternatively, in the absence of radiologically evaluable or measurable disease, two
             sequentially rising marker values each one week apart attributed by treating physician
             to germ cell tumor is permitted; either beta human chorionic gonadotropin (hCG) above
             50 mIU/ml and/or alpha-fetoprotein (AFP) above 20 ng/ml qualifies as eligible.

          3. The Eastern Cooperative Oncology Group (ECOG) Performance Score 0-2

          4. Adequate organ function as follows: Calculated creatinine clearance >/= 35cc/min,
             Absolute neutrophil count >/= 1500/mm^3, hemoglobin >/= 8 g/dL, serum calcium </= 12
             mg/dL, Platelet count >/= 75,000/mm^3, AST (SGOT)/ALT (SGPT) < 2.5 x upper limit of
             normal (ULN), Total bilirubin < 2.0mg/dl.

          5. Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or
             surgical procedures to NCI Common Terminology Criteria for Adverse Events (CTCAE)
             Version 3.0 grade </= 2.

          6. At least 18 years of age as safety of sunitinib in a pediatric population has not been
             established.

          7. Able to provide informed consent

          8. Must be able to ingest oral medication

          9. Male subjects must be surgically sterile or must agree to use effective contraception
             during the period of therapy. The definition of effective contraception will be based
             on the judgment of the principal investigator or a designated associate.

         10. Patients who have not received prior high-dose chemotherapy and stem cell rescue as
             salvage therapy will have this option discussed with them. Only patients ineligible,
             unwilling or unable to undertake this option will be eligible for this trial.

        Exclusion Criteria:

          1. NCI CTCAE Version 3.0 grade 3 hemorrhage within the 4 weeks prior to starting the
             study treatment.

          2. Any of the following within the 12 months prior to study drug administration:
             myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass
             graft, symptomatic congestive heart failure, cerebrovascular accident or transient
             ischemic attack, or pulmonary embolism.

          3. Patients with history of Long QT syndrome.

          4. Ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade >/= 2.

          5. Uncontrolled Hypertension (> 140/90 mm Hg despite optimal medical therapy).

          6. Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
             the normal range with medication.

          7. Symptomatic bowel obstruction.

          8. Prior VEGFR/PDGFR inhibitor therapy.

          9. Known human immunodeficiency virus infection, chronic active hepatitis or liver
             cirrhosis.