NCT00062478

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2001

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2003

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 12, 2003

Completed
Last Updated

March 12, 2020

Status Verified

July 1, 2019

Enrollment Period

10 months

First QC Date

June 6, 2003

Last Update Submit

March 10, 2020

Conditions

Brain NeoplasmsMalignant Neoplasms, BrainBrain Tumors

Outcome Measures

Primary Outcomes (1)

  • Objective Tumor Response Rate

    Randomization to end of treatment

Secondary Outcomes (2)

  • Overall Survival

    Randomization to date of death due to any cause

  • Overall Safety

    Randomization to end of study participation

Study Arms (1)

1

EXPERIMENTAL

Karenitecin for intravenous use

Drug: Karenitecin (BNP1350)

Interventions

Karenitecin (BNP1350)DRUG

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
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

For Information call 210-614-1701 for a site near you

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

cositecan

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2003

First Posted

June 12, 2003

Study Start

October 1, 2001

Primary Completion

August 1, 2002

Last Updated

March 12, 2020

Record last verified: 2019-07

Locations

US(1)