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Sunitinib Malate in Refractory Germ Cell Tumors

Information source: M.D. Anderson Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Genitourinary Disease

Intervention: Sunitinib Malate (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: M.D. Anderson Cancer Center

Official(s) and/or principal investigator(s):
Lance Pagliaro, MD, BA, Study Chair, Affiliation: M.D. Anderson Cancer Center

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.

Clinical Details

Official title: Phase II Study of Sunitinib Malate in Refractory Germ Cell Tumors

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

Primary outcome: Progression Free Survival Rate

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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 /= 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 /= 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.

Locations and Contacts

University of Texas MD Anderson Cancer Center, Houston, Texas 77030, United States
Additional Information

University of Texas MD Anderson Cancer Center Website

Starting date: May 2009
Last updated: December 16, 2014

Page last updated: August 23, 2015

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