Study of Karenitecin (BNP1350) in Patients With Brain Tumors

This study has been completed.

First Received: June 6, 2003 Last Updated: April 1, 2009 History of Changes

Sponsored by:	BioNumerik Pharmaceuticals, Inc.
Information provided by:	BioNumerik Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00062478

Purpose

The purpose of this study is to evaluate safety and efficacy ofKarenitecin (BNP1350) as a treatment of adults with brain tumors.

Condition	Intervention	Phase
Brain Neoplasms Malignant Neoplasms, Brain Brain Tumors	Drug: Karenitecin (BNP1350)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase 2 Treatment of Adults With Primary Malignant Glioma With Karenitecin

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer

Drug Information available for: Karenitecin

Further study details as provided by BioNumerik Pharmaceuticals, Inc.:

Primary Outcome Measures:

Objective Tumor Response Rate [ Time Frame: Randomization to end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Enrollment:	40
Study Start Date:	October 2001
Primary Completion Date:	August 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Karenitecin for intravenous use	Drug: Karenitecin (BNP1350) Karenitecin 1.0 mg/m2 administered as a single 60-minute IV infusion daily for five consecutive days. The cycle is repeated every 21 days until occurrence of progressive disease or unacceptable toxicity.

Eligibility

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062478

Locations

United States, North Carolina
For Information call 210-614-1701 for a site near you
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

BioNumerik Pharmaceuticals, Inc.

More Information

No publications provided

Responsible Party:	BioNumerik ( BioNumerik (Chief Executive Officer) )
Study ID Numbers:	KTN20405
Study First Received:	June 6, 2003
Last Updated:	April 1, 2009
ClinicalTrials.gov Identifier:	NCT00062478 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Brain Neoplasms
Central Nervous System Diseases
Central Nervous System Neoplasms

Glioma
Brain Diseases
Nervous System Neoplasms

Additional relevant MeSH terms:

Brain Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases

Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on September 02, 2009