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Sunitinib Malate in Refractory Germ Cell Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00912912
Recruitment Status : Terminated (Slow Accrual)
First Posted : June 3, 2009
Results First Posted : January 27, 2016
Last Update Posted : April 15, 2016
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Genitourinary Disease Drug: Sunitinib Malate Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Sunitinib Malate in Refractory Germ Cell Tumors
Study Start Date : May 2009
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sunitinib Malate
Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
Drug: Sunitinib Malate
50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
Other Names:
  • SU011248
  • Sutent

Primary Outcome Measures :
  1. 12 Week Progression Free Survival Rate in Refractory Germ Cell Tumors Treated With Sunitinib Malate [ Time Frame: 12 weeks ]
    Measurable disease or response recorded from start of treatment until disease progression/recurrence. Participants who die during therapy or are lost to follow-up shall be counted as progressive disease. Progressive disease defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Evaluation of measurable disease response follows Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00912912

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Study Chair: Lance Pagliaro, MD, BA M.D. Anderson Cancer Center
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00912912    
Other Study ID Numbers: 2006-0685
NCI-2012-01645 ( Registry Identifier: NCI CTRP )
First Posted: June 3, 2009    Key Record Dates
Results First Posted: January 27, 2016
Last Update Posted: April 15, 2016
Last Verified: March 2016
Keywords provided by M.D. Anderson Cancer Center:
Refractory Germ Cell Tumors
Advanced germ cell tumors
Sunitinib Malate
Additional relevant MeSH terms:
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Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action