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Study of Karenitecin (BNP1350) in Patients With Brain Tumors

This study has been completed.
Sponsor:
Information provided by:
BioNumerik Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00062478
First received: June 6, 2003
Last updated: April 1, 2009
Last verified: April 2009
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Treatment of Adults With Primary Malignant Glioma With Karenitecin

Resource links provided by NLM:

MedlinePlus related topics: Brain Cancer Cancer
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
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

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

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

ClinicalTrials.gov processed this record on May 21, 2013