Trials Sponsors Conditions Drugs Pricing

Conditions

Brain Neoplasms Malignant Neoplasms, Brain Brain 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

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

Crown Bioscience
Industrycollaborator
BioNumerik Pharmaceuticals, Inc.
Industrylead

Study Sites (1)

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

Durham, North Carolina, 27710, United States

MeSH Terms

Conditions

Brain Neoplasms

Interventions

cositecan

Condition Hierarchy (Ancestors)

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

Enrollment

40 participants (actual enrollment reported by the registry).

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 2001

Date type not reported

This date has not been verified as actual or estimated.

Study of Karenitecin (BNP1350) in Patients With Brain Tumors

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

1

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

1

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Source record

Locations