Study of Karenitecin (BNP1350) in Patients With Brain Tumors

BioNumerik Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Brain Tumors; Malignant Neoplasms, Brain; Brain Neoplasms

Treatments: Drug: Karenitecin (BNP1350)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00062478

KTN20405

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

1

Experimental group

Description:

Karenitecin for intravenous use

Treatment:

Drug: Karenitecin (BNP1350)