Sunitinib Tumor Levels in Patients Not on Enzyme-Inducing Anti-Epileptic Drugs Undergoing Debulking Surgery for Recurrent Glioblastoma
NCT00864864
ABOUT THIS STUDY
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- 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
- 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
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Descriptive Information | ||||
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Brief Title ICMJE | Sunitinib Tumor Levels in Patients Not on Enzyme-Inducing Anti-Epileptic Drugs Undergoing Debulking Surgery for Recurrent Glioblastoma | |||
Official Title ICMJE | Pilot Study of Sunitinib Tumor Levels in Patients Not on Enzyme-Inducing Anti-Epileptic Drugs Undergoing Debulking Surgery for Recurrent Glioblastoma | |||
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 by blocking blood flow to tumors, which may prevent them from growing further. At the present time, there is no chemotherapy that can cure glioblastoma. The reason why chemotherapy is not fully effective is that many drugs cannot penetrate into brain tumors. This is due to the presence of the blood-brain barrier (BBB) which normally protects the brain from substances in the blood. | |||
Detailed Description |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Early Phase 1 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE |
| |||
Intervention ICMJE | Drug: Sunitinib
Taken orally on days 1-7 prior to surgery and then starting again on Day 22 for 4 weeks followed by a 2 week rest period | |||
Study Arms ICMJE | Experimental: Sunitinib
Intervention: Drug: Sunitinib | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 8 | |||
Original Estimated Enrollment ICMJE | 12 | |||
Actual Study Completion Date ICMJE | May 2013 | |||
Actual Primary Completion Date | May 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00864864 | |||
Other Study ID Numbers ICMJE | 06-307 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Scott Randall Plotkin, MD, PhD, Massachusetts General Hospital | |||
Study Sponsor ICMJE | Massachusetts General Hospital | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Massachusetts General Hospital | |||
Verification Date | July 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |