Study of Karenitecin (BNP1350) in Patients With Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00062478
Recruitment Status : Completed
First Posted : June 12, 2003
Last Update Posted : October 23, 2018
Information provided by (Responsible Party):
BioNumerik Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Brain Neoplasms Malignant Neoplasms, Brain Brain Tumors Drug: Karenitecin (BNP1350) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Treatment of Adults With Primary Malignant Glioma With Karenitecin
Study Start Date : October 2001
Actual Primary Completion Date : August 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arm Intervention/treatment
Experimental: 1
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.
Other Name: Karenitecin also referred to as BNP1350

Primary Outcome Measures :
  1. Objective Tumor Response Rate [ Time Frame: Randomization to end of treatment ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Randomization to date of death due to any cause ]
  2. Overall Safety [ Time Frame: Randomization to end of study participation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00062478

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.

Responsible Party: BioNumerik Pharmaceuticals, Inc. Identifier: NCT00062478     History of Changes
Other Study ID Numbers: KTN20405
First Posted: June 12, 2003    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action