Brain and Nerves |
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Clinical Trial: Study of Karenitecin (BNP1350) in Patients with Brain Tumors
This study is no longer recruiting patients.
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Purpose
The purpose of this study is to determine if Karenitecin (BNP1350) is effective in the treatment of brain tumors.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Brain Neoplasms Malignant Neoplasms, Brain Brain Tumors | Drug: Karenitecin (BNP1350) | Phase II |
MedlinePlus related topics: Brain Cancer
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase 2 Treatment of Adults with Primary Malignant Glioma with Karenitecin
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
Location Information
North Carolina
For Information call 210-614-1701 for a site near you, Durham, North Carolina, 27710, United States
More Information
Record last reviewed: March 2005
Last Updated: March 3, 2005
Record first received: June 6, 2003
ClinicalTrials.gov Identifier: NCT00062478
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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