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Completed

NCT Number: NCT00062478

Study of Karenitecin (BNP1350) in Patients With Brain Tumors

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

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Key information

Conditions

Brain Neoplasms Brain Diseases Brain Tumors Central Nervous System Diseases Central Nervous System Neoplasms Malignant Neoplasms, Brain Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

For Information call 210-614-1701 for a site near you

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Karenitecin (BNP1350)

Drug

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 names: Karenitecin also referred to as BNP1350

Primary outcomes

  1. Objective Tumor Response Rate

    Time frame: Randomization to end of treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

BioNumerik Pharmaceuticals, Inc.

Industry

Collaborators

  • Crown Bioscience

Registry information

Official study title

Phase 2 Treatment of Adults With Primary Malignant Glioma With Karenitecin

Important dates

Study start
2001
Primary completion
2002
First posted
Jun 12, 2003
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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