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Phase II Study of Sunitinib Malate in Refractory Germ Cell Tumors


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Genitourinary Disease

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Trial Information

Phase II Study of Sunitinib Malate in Refractory Germ Cell Tumors


The Study Drug:

Sunitinib malate is designed to block pathways that control important events such as the
growth of blood vessels that are essential for the growth of cancer.

Within 14 days of enrollment on this study, you will have the following tests and procedures
performed:

- Your complete medical history will be recorded.

- You will have a physical exam.

Within 7 days of enrollment on this study, you will have the following tests and procedures
performed:

-Blood (about 3 teaspoons) and urine will be collected for routine testing and to test for
certain biomarkers (to check the status of the disease).

Study Drug Administration:

If you are found to be eligible to take part in this study, you will take sunitinib malate
capsules once a day (by mouth) for 4 weeks in a row followed by 2 weeks with no study drug.
These 6 weeks are considered 1 cycle of study treatment.

Study Visits:

On Day 1 of each cycle (about every 6 weeks), you will have the following tests done before
you take the study drug:

- You will have a physical exam.

- You will be asked about how you are feeling and about any side effects you have
experienced since your last visit.

- You will have blood (about 3 teaspoons) and urine collected for routine tests and to
test for certain biomarkers.

For the first 4 weeks of treatment, you should have your blood pressure monitored. This may
be done at your home with a digital pressure device, or you may visit your local doctor for
this testing.

About Day 21 of Cycles 1 and 2, blood (about 2- 3 teaspoons) will be drawn for routine
tests. This may be done at your local doctor's office and results faxed to the study doctor.

On Day 1 of Cycle 2, Day 1 of Cycle 3, and then Day 1 of every 2 cycles after that (Cycle 5,
Cycle 7, and so on), you will have imaging scans to check status of the disease. This could
include CT or MRI scans, an ECG, and a chest x-ray. If your doctor thinks it is necessary,
you may have additional imaging scans at any time.

On Day 1 of every other cycle (Cycle 3, Cycle 5, and so on), you will have an echocardiogram
or MUGA scan.

Length of Study:

You may remain on study for as long as you are benefitting. You will be taken off study if
intolerable side effects occur or if the disease gets worse. However, if the disease gets
worse very quickly during Cycles 1 or 2, you will be taken off study at that time.

Off-Study Visit:

When you are taken off of treatment on this study, the following tests and procedures will
be performed:

- You will have a physical exam.

- You will be asked how you are feeling and about any changes in your medical history
since beginning this study.

- You will also be asked about any side effects you have experienced since your last
visit.

This is an investigational study. Sunitinib malate is approved by the FDA for the treatment
of adults with kidney cancer. Its use in patients with germ cell tumors is investigational.
Up to 42 patients will take part in this study. All will be enrolled at M. D. Anderson.


Inclusion Criteria:



1. Progressive metastatic 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 HCG above 50 mIU/ml and/or AFP
above 20 ng/ml qualifies as eligible.

3. 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 mg/dL, Platelet count >/= 75,000/mm^3, AST/ALT < 2.5 x ULN, Total bilirubin <
2.0mg/dl.

5. Resolution of all acute toxic effects of prior chemotherapy or radiotherapy or
surgical procedures to NCI CTCAE Version 3.0 grade
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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival Rate

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Lance Pagliaro, MD, BA

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2006-0685

NCT ID:

NCT00912912

Start Date:

June 2009

Completion Date:

Related Keywords:

  • Genitourinary Disease
  • Genitourinary
  • Testis
  • Refractory Germ Cell Tumors
  • Advanced germ cell tumors
  • GCTs
  • Sunitinib Malate
  • Sutent
  • SU011248
  • Urologic Diseases
  • Neoplasms, Germ Cell and Embryonal

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030