Brain Neoplasms, Brain Tumors, Malignant Neoplasms, Brain
Conditions
Brief summary
The purpose of this study is to evaluate safety and efficacy ofKarenitecin (BNP1350) as a treatment of adults with brain tumors.
Interventions
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.
Sponsors
Crown Bioscience
BioNumerik Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Tumor Response Rate | Randomization to end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | Randomization to date of death due to any cause |
| Overall Safety | Randomization to end of study participation |
Countries
United States
Outcome results
None listed