Study of Karenitecin (BNP1350) in Patients With Brain Tumors

Sponsor

BioNumerik Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00062478

Collaborator

Crown Bioscience (Industry)

Enrollment

Location

Arm

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Neoplasms Malignant Neoplasms, Brain Brain Tumors	Drug: Karenitecin (BNP1350)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase 2 Treatment of Adults With Primary Malignant Glioma With Karenitecin

Study Start Date :

Oct 1, 2001

Actual Primary Completion Date :

Aug 1, 2002

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Objective Tumor Response Rate [Randomization to end of treatment]

Secondary Outcome Measures

Overall Survival [Randomization to date of death due to any cause]
Overall Safety [Randomization to end of study participation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For Information call 210-614-1701 for a site near you	Durham	North Carolina	United States	27710

Sponsors and Collaborators

BioNumerik Pharmaceuticals, Inc.
Crown Bioscience

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

BioNumerik Pharmaceuticals, Inc.

ClinicalTrials.gov Identifier:

NCT00062478

Other Study ID Numbers:

KTN20405

First Posted:

Jun 12, 2003

Last Update Posted:

Mar 12, 2020

Last Verified:

Jul 1, 2019

Additional relevant MeSH terms:

Neoplasms

Brain Neoplasms

Camptothecin

Study Results

No Results Posted as of Mar 12, 2020