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Study of Karenitecin (BNP1350) in patients with brain tumors



Study of Karenitecin (BNP1350) in patients with brain tumors

For Condition: Brain Neoplasms,Brain Tumors,Malignant Neoplasms, Brain
Status: Recruiting
Sponsor(s): BioNumerik Pharmaceuticals, Inc. ,
Synopsis: The purpose of this study is to determine if Karenitecin (BNP1350) is effective in the treatment of Brain Tumors
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: - Confirmed diagnosis of a newly diagnosed glioblastoma multiforme or recurrent/progressive glioblastoma multiforme, anaplastic astrocytoma, or anaplastic oligodendroglioma. - Evidence of measurable recurrent or residual primary CNS neoplasm. - An interval of at least 3 weeks between prior surgical resection or 6 weeks between prior radiotherapy or chemotherapy, and enrollment on this protocol unless there is unequivocal evidence of tumor progression after surgery, radiotherapy, or chemotherapy. - Hematocrit > 29%, ANC > 1,500, platelets > 125,000 - Serum creatinine < 1.5 mg/dl, BUN < 25 mg/dl, serum SGOT and bilirubin < 1.5 times upper limit of normal - Negative pregnancy test for female patients
Total Enrollment: 

Location and Contact Information:

For Information call 210-614-1701 for a site near you *Recruiting*
Durham,  North Carolina,  27710
United States
Recruiting Clinical  Department BioNumerik Pharmaceuticals 210-614-1701


Additional Information:
Study ID Numbers:
  KTN20405; 
Study Start Date: 
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00062478

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