Treatment of Von Hippel-Lindau (VHL)-Related Hemangioblastoma With PTK787/ZK 222584

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Brief Title

Treatment of Von Hippel-Lindau (VHL)-Related Hemangioblastoma With PTK787/ZK 222584

Official Title

A Phase II Open-Label Study of Oral, Continuous, Once Daily PTK787/ZK 222584 in Patients With Von Hippel-Lindau Disease (VHL) and Hemangioblastoma (HB)

Brief Summary

      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. The
      study will also assess safety and tolerability of PTK787/ZK 222584, and changes in markers of
      angiogenesis (new blood vessel growth).
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Evaluate efficacy

Secondary Outcome

 Evaluate changes in dynamic contrast enhanced magnetic resonance imaging

Condition

Von Hippel-Lindau Disease

Intervention

PTK787/ZK 222584

Study Arms / Comparison Groups

 PTK787/ZK 222584
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

11

Start Date

February 2003


Primary Completion Date

June 2006

Eligibility 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)

          -  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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Novartis, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00052013

Organization ID

CPTK787 0144



Study Sponsor

Novartis Pharmaceuticals


Study Sponsor

Novartis, Study Chair, Novartis


Verification Date

February 2011