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Phase 2 Treatment of Adults With Primary Malignant Glioma With Karenitecin


Phase 2
18 Years
N/A
Not Enrolling
Both
Brain Neoplasms, Malignant Neoplasms, Brain, Brain Tumors

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Trial Information

Phase 2 Treatment of Adults With Primary Malignant Glioma With Karenitecin

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Tumor Response Rate

Outcome Time Frame:

Randomization to end of treatment

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

KTN20405

NCT ID:

NCT00062478

Start Date:

October 2001

Completion Date:

Related Keywords:

  • Brain Neoplasms
  • Malignant Neoplasms, Brain
  • Brain Tumors
  • Brain Neoplasms
  • Neoplasms

Name

Location

For Information call 210-614-1701 for a site near youDurham, North Carolina  27710