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Home > "T" Clinical Trials Conditions > Treatment of VHL-related hemangioblastoma with PTK787/ZK 222584  Treatment of VHL-related hemangioblastoma with PTK787/ZK 222584
Treatment of VHL-related hemangioblastoma with PTK787/ZK 222584
For Condition: CNS hemangioblastoma,Retinal Hemangioblastoma,von Hippel-Lindau Disease
Status: Recruiting
Sponsor(s): Novartis Pharmaceuticals ,
Synopsis: The purpose of this study is to determine whether PTK787/ZK 222584 is effective in treating hemangioblastoma of the brain and/or retina in patients with von Hippel-Lindau disease, and to determine if there is any effect of PTK787/ZK 222584 on the metabolism of midazolam in a subset of patients.The study will also assess safety and tolerability of PTK787/ZK 222584, and changes in markers of angiogenesis (new blood vessel growth).
Details:
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion criteria - Confirmed diagnosis of VHL disease - One or more measurable CNS hemangioblastoma, if symptomatic, must be refractory or not amenable to standard therapy, if asymptomatic, must have had at least one prior neurosurgical treatment/ procedure; and/or: at least one untreatable or treatment-refractory retinal hemangioblastoma that is causing impaired visual function - Karnofsky Performance Status >=60 - Life expectancy > 3 months - Able to sign informed consent - Adequate hematologic status, liver and kidney function Exclusion criteria: - Patients with other VHL-related tumors requiring or amenable to standard treatment - Severe or uncontrolled concurrent illnesses that could compromise participation in the study - Total urinary protein in 24 hour collection > 500 mg - Pregnant or breast feeding females, adults of reproductive potential not using effective contraception (hormonal methods not considered effective due to possible decreased effectiveness secondary to drug interaction with PTK787). Women of childbearing potential must have negative serum pregnancy test prior to initiation of treatment. - Acute or chronic liver disease - Diagnosis of HIV infection - GI function that may alter absorption of PTK787 - Patients taking coumadin (warfarin sodium) - Patients with contraindication to midazolam, or patients requiring other medications contraindicated for use with midazolam - Prior therapies (investigational drugs, chemotherapy) within 4 weeks prior to study entry - Prior therapies (biologic, hormonal, immunotherapy, radiation therapy, surgery) within two weeks prior to study entry. - Patients unwilling or unable to comply with protocol requirements - Patients with concurrent, non VHL-related malignancies other than non-melanoma skin cancer - Patients with contraindication to MRI imaging
Total Enrollment: 15
Location and Contact Information:
Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Daniel George 617-632-3466
Additional Information:
Study ID Numbers: CPTK787 0144;
Study Start Date: January 2003
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00052013
Other Von Hippel-Lindau Disease Studies:
1. Treatment of VHL-related hemangioblastoma with PTK787/ZK 222584
Related Studies:
Other von Hippel-Lindau Disease Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Treatment of VHL-related hemangioblastoma with PTK787/ZK 222584
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