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A Phase I/II Study of Topotecan by Intracerebral Clysis for the Treatment of Recurrent Primary Malignant Brain Tumors

Phase 1
1 Year
Open (Enrolling)
Recurrent Anaplastic Astrocytoma, Recurrent Anaplastic Oligodendroglioma, Recurrent Anaplastic Oligo-Astrocytoma, Recurrent Glioblastoma Multiforme

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Trial Information

A Phase I/II Study of Topotecan by Intracerebral Clysis for the Treatment of Recurrent Primary Malignant Brain Tumors

Candidates will be screened with a physical examination, neurological examination, Karnofsky
performance status, magnetic resonance imaging (MRI) of the brain, and routine laboratory
tests. Eligible candidates will be admitted to the hospital for Stereotactic biopsy of the
recurrent brain tumor and then have placement of two catheters into the tumor. It will be
followed with 4-5 days of a slow infusion of Topotecan directly into the tumor using the
catheter and microinfusion pump. Candidates will be evaluated daily with MRI of the brain
and neurological exam. Once the infusion of Topotecan is complete and the catheters are
discontinued, the candidate is discharged home in approximately 24 hours. Follow-up visits
after hospitalization will be monthly for four visits and then every eight weeks. At each
follow-up visit a neurological exam, Karnofsky performance status, routine laboratory tests
and a MRI of the brain will be performed.

Inclusion Criteria


- Patients with recurrent primary malignant brain tumors.

- Patient must have been previously treated with external beam radiation, which is the
standard of care.

- An MR scan must be obtained within 30 days of enrollment and must demonstrate an
enhancing mass without significant mass effect. Tumors must be ≤ 100cc in total
volume. The lesion must be stereotactically accessible.

- Patient must have demonstrated evidence of increasing contrast enhancement on MR or
CT imaging while on stable or increasing dose of steroid.

- Karnofsky performance score of greater than or equal to 60.

- Men and women of child-bearing potential must practice birth control. Women of child
bearing age must have a negative serum or urine pregnancy test within 7 days of study

- Patient must possess the ability to give Informed Consent. Parent or guardian may
give informed consent for minors.

- Patient must be willing to and medically capable of undergoing the surgical

- Patients may not be receiving other investigational agent for the treatment of
malignant brain tumor.

- Patients must be at least 1 year old to participate in the study.


- Patients with diffuse subependymal or CSF disease.

- Patients with tumors involving the cerebellum, or both hemispheres.

- Patients with an active infection requiring treatment or having an unexplained
febrile illness.

- Patients who are known HIV positive or who are known positive for Hepatitis B or C

- Patients who have received any form of radiation or chemotherapy within 4 weeks of
protocol enrollment.

- Patients with systemic diseases which may be associated with unacceptable
anesthetic/operative risk.

- Patients who have previously received systemic topotecan for their tumor

- Patients less than 1 year of age

- Patients who are not able to receive an MRI scan

Type of Study:


Study Design:

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

Outcome Measure:

Time to tumor progression

Outcome Time Frame:

treatment to tumor progression

Safety Issue:


Principal Investigator

Jeffrey N Bruce, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University Department of Neurosurgery


United States: Food and Drug Administration

Study ID:

AAAA4229 (I/II)



Start Date:

October 2003

Completion Date:

March 2013

Related Keywords:

  • Recurrent Anaplastic Astrocytoma
  • Recurrent Anaplastic Oligodendroglioma
  • Recurrent Anaplastic Oligo-Astrocytoma
  • Recurrent Glioblastoma Multiforme
  • Brain Tumors
  • Intracerebral Clysis
  • Topotecan
  • MRI
  • Astrocytoma
  • Brain Neoplasms
  • Glioblastoma
  • Oligodendroglioma



Columbia University Department of Neurosurgery New York City, New York  10032