Back to resultsStudy of Karenitecin (BNP1350) in Patients With Brain Tumors
Primary Purpose
Brain Neoplasms, Malignant Neoplasms, Brain, Brain Tumors
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Karenitecin (BNP1350)
Sponsored by
About this trial
This is an interventional treatment trial for Brain Neoplasms
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
Sites / Locations
- For Information call 210-614-1701 for a site near you
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Karenitecin for intravenous use
Outcomes
Primary Outcome Measures
Objective Tumor Response Rate
Secondary Outcome Measures
Overall Survival
Overall Safety
Full Information
NCT ID
NCT00062478
First Posted
June 6, 2003
Last Updated
March 10, 2020
Sponsor
BioNumerik Pharmaceuticals, Inc.
Collaborators
Crown Bioscience
1. Study Identification
Unique Protocol Identification Number
NCT00062478
Brief Title
Study of Karenitecin (BNP1350) in Patients With Brain Tumors
Official Title
Phase 2 Treatment of Adults With Primary Malignant Glioma With Karenitecin
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
August 2002 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioNumerik Pharmaceuticals, Inc.
Collaborators
Crown Bioscience
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate safety and efficacy ofKarenitecin (BNP1350) as a treatment of adults with brain tumors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms, Malignant Neoplasms, Brain, Brain Tumors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Karenitecin for intravenous use
Intervention Type
Drug
Intervention Name(s)
Karenitecin (BNP1350)
Other Intervention Name(s)
Karenitecin also referred to as BNP1350
Intervention Description
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.
Primary Outcome Measure Information:
Title
Objective Tumor Response Rate
Time Frame
Randomization to end of treatment
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
Randomization to date of death due to any cause
Title
Overall Safety
Time Frame
Randomization to end of study participation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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
Facility Information:
Facility Name
For Information call 210-614-1701 for a site near you
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Karenitecin (BNP1350) in Patients With Brain Tumors
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