Status:
COMPLETED
PTK787/ZK 222584 in Combination With Temozolomide and Radiation in Patients With Glioblastoma Taking Enzyme-Inducing Anti-Epileptic Drugs
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Dana-Farber Cancer Institute
Novartis
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
PTK is an investigational new drug that has been shown in early laboratory studies to prevent the formation of new blood vessels that allow the tumor to grow. These studies have shown that the study d...
Detailed Description
* Since we are looking for the highest dose of PTK that can be administered safely without severe or unmanageable side effects, not everyone who participates will get the same dose of PTK. A small gro...
Eligibility Criteria
Inclusion
- All patients must have histologically verified glioblastoma. Patients mus have paraffin blocks of tumor that must be sent for analysis.
- 18 years of age or older
- Karnofsky Performance Status greater than or equal to 60
- Adequate laboratory values as described by the protocol
- Life expectancy of greater than 12 weeks
- Patient must be able to undergo serial MR imaging
- Patients must be on an enzyme-inducing anti-epileptic drug(s) as listed in the protocol
- No steroids or a stable dose of steroids for at least 5 days or a decreasing dose
- Mini-mental status examination of 15 or greater
Exclusion
- Pregnant or breast-feeding women
- Concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast
- Prior chemotherapy or cranial radiation therapy for glioblastoma
- Prior biologic or immunotherapy less than 2 weeks prior to registration
- If the patient surgery is more than 16 days or less than 13 days from the start of PTK787/ZK 222854
- Prior therapy with anti-VEGF agents
- Pleural effusion or ascites that causes respiratory compromise
- Concurrent severe and/or uncontrolled medical conditions which could compromise participation is the study
- Impairment of gastrointestinal function or GI disease that may significantly alter the absorption of PTK787/ZK 222584
- Confirmed diagnosis of human immunodeficiency virus (IV)
- Patients who are taking therapeutic warfarin sodium or other anticoagulants or anti-platelet agents
- Patients requiring aprepitant, dolasetron, and tropisetron as antiemetics are excluded
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00385853
Start Date
September 1 2006
End Date
September 1 2011
Last Update
October 21 2013
Active Locations (2)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115