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CompletedNCT00062478Updated Mar 12, 2020

Study of Karenitecin (BNP1350) in Patients With Brain Tumors

A Phase 2 interventional study of Karenitecin (BNP1350) in Brain Neoplasms, Malignant Neoplasms, Brain and Brain Tumors, sponsored by BioNumerik Pharmaceuticals, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-12.

Sponsored by BioNumerik Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Brain Neoplasms
  • Malignant Neoplasms, Brain
  • Brain Tumors
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 40 is below the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

BioNumerik Pharmaceuticals, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    1

    Karenitecin for intravenous use

    Drug: Karenitecin (BNP1350)

Interventions

  • DrugKarenitecin (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.

    Also known as: Karenitecin also referred to as BNP1350

06

What researchers measure

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

07

Study locations

1 site
  • For Information call 210-614-1701 for a site near you
    Durham, North Carolina 27710, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00062478
Lead sponsor
BioNumerik Pharmaceuticals, Inc.
Collaborators
Crown Bioscience
Responsible party
Sponsor
First posted
Jun 12, 2003
Start date
Oct 2001
Primary completion
Aug 2002
Last update
Mar 12, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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