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

Sponsor:	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

U.S. FDA Resources

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nervous System Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Central Nervous System Neoplasms
Brain Diseases
Camptothecin

Pharmacologic Actions
Brain Neoplasms
Neoplasms
Neoplasms by Site
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Nervous System Neoplasms

ClinicalTrials.gov processed this record on November 22, 2009