Study of Karenitecin (BNP1350) in Patients With Brain Tumors - Tabular View

Tracking Information
First Received Date ^ICMJE	June 6, 2003
Last Updated Date	April 1, 2009
Start Date ^ICMJE	October 2001
Primary Completion Date	August 2002 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 6, 2008)	Objective Tumor Response Rate [ Time Frame: Randomization to end of treatment ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00062478 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 6, 2008)	Overall Survival [ Time Frame: Randomization to date of death due to any cause ] [ Designated as safety issue: No ] Overall Safety [ Time Frame: Randomization to end of study participation ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Study of Karenitecin (BNP1350) in Patients With Brain Tumors
Official Title ^ICMJE	Phase 2 Treatment of Adults With Primary Malignant Glioma With Karenitecin
Brief Summary	The purpose of this study is to evaluate safety and efficacy ofKarenitecin (BNP1350) as a treatment of adults with brain tumors.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Brain Neoplasms Malignant Neoplasms, Brain Brain Tumors
Intervention ^ICMJE	Drug: Karenitecin (BNP1350)
Study Arms / Comparison Groups	Experimental: Karenitecin for intravenous use
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 ^ICMJE	Completed
Enrollment ^ICMJE	40
Completion Date
Primary Completion Date	August 2002 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00062478
Responsible Party	BioNumerik (Chief Executive Officer), BioNumerik
Study ID Numbers ^ICMJE	KTN20405
Study Sponsor ^ICMJE	BioNumerik Pharmaceuticals, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	BioNumerik Pharmaceuticals, Inc.
Verification Date	April 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP