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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on November 27, 2014