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Sunitinib Malate in Refractory Germ Cell Tumors

This study has been terminated.
(Slow Accrual)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center Identifier:
First received: June 1, 2009
Last updated: March 17, 2016
Last verified: March 2016
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 Intervention Phase
Genitourinary Disease
Drug: Sunitinib Malate
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Sunitinib Malate in Refractory Germ Cell Tumors

Resource links provided by NLM:

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • 12 Week Progression Free Survival Rate in Refractory Germ Cell Tumors Treated With Sunitinib Malate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.

Enrollment: 5
Study Start Date: May 2009
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00912912

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Study Chair: Lance Pagliaro, MD, BA M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00912912     History of Changes
Other Study ID Numbers: 2006-0685  NCI-2012-01645 
Study First Received: June 1, 2009
Results First Received: December 21, 2015
Last Updated: March 17, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Refractory Germ Cell Tumors
Advanced germ cell tumors
Sunitinib Malate

Additional relevant MeSH terms:
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors processed this record on October 25, 2016