Status:
COMPLETED
Sunitinib Tumor Levels in Patients Not on Enzyme-Inducing Anti-Epileptic Drugs Undergoing Debulking Surgery for Recurrent Glioblastoma
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Conditions:
Glioblastoma
Brain Tumor
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this research study is to determine if sunitinib can get past the blood-brain barrier and into the brain tumor. Sunitinib has shown promising results in treating other cancers and works...
Detailed Description
* Participants will take the study drug, sunitinib, for 7 days prior to their surgery. The surgery is part of the routine care for glioblastoma and will be performed on Day 8. The study drug is suppli...
Eligibility Criteria
Inclusion
- Histologically confirmed glioblastoma
- 18 years of age or older
- Karnofsky Performance Status 60 or greater
- Patient must be on no anti-epileptic drugs (AED) or AED that are non-enzyme inducing (NEIAED)
- There is no limit to the number of prior chemotherapy regimens
- No concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast. Patients with prior malignancies must be disease-free for 5 years or more
- Mini-mental status examination score of 15 or less
- Resolution of all acute toxic effect of prior chemotherapy, radiotherapy, or surgical procedures to grade 1 or less
- Adequate organ function as outlined in the protocol
Exclusion
- Major surgery within 4 weeks of starting the study treatment
- Radiation therapy within 3 months of starting the study treatment
- Chemotherapy within 4 weeks (within 6 weeks for nitrosoureas) prior to entering the study
- Concurrent treatment on another clinical trial. Supportive care trials or non-treatment trials are allowed
- Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure. stroke or transient ischemic attack, or pulmonary embolism
- Ongoing cardiac dysrhythmias of NCI CTCAE grade 2 or greater
- Prolonged QTc interval on baseline EKG
- Hypertension that cannot be controlled by medications
- Patients must not have a known coagulopathy that increases risk of bleeding or a history of clinically significant hemorrhages in the past
- Patients must be on therapeutic doses of anti-coagulants or anti-platelet agents while taking sunitinib
- Grade 3 systemic hemorrhage within 4 weeks fo starting the study treatment
- Patients whose MRI scan shows clinically significant intratumoral or peritumoral hemorrhage
- Pre-existing thyroid abnormality with thyroid function that cannot be maintained in the normal range with medication
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or active infection
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the subject inappropriate for entry into this study
- Concomitant use of ketoconazole and other agents known to induce CYP3A4
- Pregnancy or breastfeeding
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to sunitinib
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00864864
Start Date
May 1 2007
End Date
May 1 2013
Last Update
July 7 2016
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115