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

Phase 1/Phase 2
1 Year
Open (Enrolling)
Brain Neoplasms, Primary Malignant

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Trial Information

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

Clinical efficacy with chemotherapy has been discouraging for malignant brain tumors, mostly
because of side effects and delivery limitations. Because they are locally invasive and
rarely metastasize, malignant gliomas have features that make them uniquely amenable to new
strategies of regional drug delivery. Intracerebral clysis (convection-enhanced delivery) is
a novel drug delivery strategy that uses a microinfusion pump to establish a pressure
gradient in the brain via implanted catheters. The pressure gradient produces convective
forces that distribute a therapeutic agent throughout the tumor and surrounding brain

Non-invasive MRI methods of monitoring drug distribution and treatment response have been
developed to maximize the clinical applications and minimize complications associated with
treatment risks.

Study participants will be taken to the operating room to have 2 catheters surgically placed
into their tumor and surrounding tumor bed. These catheters will then be connected to small
infusion pumps which will slowly infuse topotecan continuously over 4-5 days. Patients will
have daily MRI scans while in the hospital. Upon completion of the experimental treatment,
patients will be discharged and will be followed up in the outpatient clinic.

Inclusion Criteria:

- Single primary malignant brain tumor

- Previous treatment with external beam radiation

- Tumor is stereotactically accessible

- Karnofsky Performance Score at least 60

Exclusion Criteria:

- Diffuse subependymal or CSF disease

- Tumor involves brainstem, cerebellum or both hemispheres

- Active infection

- Systemic disease associated with unacceptable anesthetic/operative risk

- Previous treatment with topotecan

- Unable to receive MRI scans

Type of Study:


Study Design:

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

Outcome Measure:

Time to tumor progression/recurrence

Outcome Time Frame:

treatment to progression

Safety Issue:


Principal Investigator

Jeffrey Bruce, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Columbia University


United States: Food and Drug Administration

Study ID:




Start Date:

March 2004

Completion Date:

March 2013

Related Keywords:

  • Brain Neoplasms, Primary Malignant
  • Recurrent Primary Malignant Brain Tumors
  • Brain Tumors
  • Neoplasms, Brain
  • Brain Cancer
  • Brain cancer treatment
  • Topotecan
  • Brain Neoplasms
  • Neoplasms



Columbia University Medical Center Neurological Institute New York, New York  10032