Study of Karenitecin (BNP1350) in Patients With Brain Tumors

Phase 2 Treatment of Adults With Primary Malignant Glioma With Karenitecin

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

Study Overview

• Status: Completed
• Conditions: Brain Neoplasms; Brain Tumors; Malignant Neoplasms, Brain
• Intervention / Treatment: Drug: Karenitecin (BNP1350)

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: Karenitecin also referred to as BNP1350

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective Tumor Response Rate	Randomization to end of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival	Randomization to date of death due to any cause
Overall Safety	Randomization to end of study participation

Collaborators and Investigators

• Sponsor: BioNumerik Pharmaceuticals, Inc.
• Collaborators: Crown Bioscience

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Primary Completion (Actual): August 1, 2002

Study Registration Dates

• First Submitted: June 6, 2003
• First Submitted That Met QC Criteria: June 11, 2003
• First Posted (Estimate): June 12, 2003

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 10, 2020
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms; Brain Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Antineoplastic Agents, Phytogenic; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Camptothecin
• Other Study ID Numbers: KTN20405