Overview

Study of Karenitecin (BNP1350) in Patients With Brain Tumors

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate safety and efficacy ofKarenitecin (BNP1350) as a treatment of adults with brain tumors.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
BioNumerik Pharmaceuticals, Inc.
Collaborator:
Crown Bioscience
Treatments:
Camptothecin
Criteria
- 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