Study of Karenitecin (BNP1350) in Patients With Brain Tumors

Brain Neoplasms Clinical Trial

Official title:

Phase 2 Treatment of Adults With Primary Malignant Glioma With Karenitecin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00062478
• Other study ID #: KTN20405
• Status: Completed
• Phase: Phase 2
• Start date: October 2001

Study information

• Verified date: July 2019
• Source: BioNumerik Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: August 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	For Information call 210-614-1701 for a site near you	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
BioNumerik Pharmaceuticals, Inc.	Crown Bioscience, Inc. became karenitecin IND 057250 Sponsor on April 8, 2019

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Tumor Response Rate		Randomization to end of treatment
Secondary	Overall Survival		Randomization to date of death due to any cause
Secondary	Overall Safety		Randomization to end of study participation