Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03154996 : Chronic Convection Enhanced Delivery of Topotecan
PhasePhase 1
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

- Patients must have a recurrent malignant glioma (World Health Organization (WHO) grade
III-IV), including recurrent glioblastoma, anaplastic astrocytoma, anaplastic
oligodendroglioma, anaplastic oligoastrocytoma, and anaplastic ependymoma.
Stereotactic biopsies will be performed to confirm this diagnosis prior to initiating
the treatment.

- Patients with tumors of the brain must have been previously treated with surgical
resection, external beam radiation, and temozolomide chemotherapy.

- An magnetic resonance (MR) scan must be obtained within 30 days of enrollment and must
demonstrate an enhancing mass without significant mass effect. Tumors must be less
than 32 cc in total volume. The lesion must be stereotactically accessible.

- Patients must have demonstrated evidence of increasing contrast enhancement on MR or
computed tomography (CT) imaging while on stable or increasing dose of steroid.

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

- Men and women of childbearing potential must practice birth control. Women of child
bearing potential must have a urine pregnancy test within 7 days of study entry.

- Patients must possess the ability to give Informed Consent.

- Patients must be willing to and medically capable of undergoing the surgical
operation.

- There is no upper age limit. Patients at extreme upper end of the age spectrum will
not be automatically excluded, but will be carefully scrutinized to determine their
suitability for this procedure.

- Patients must be at least 18 years old.

- Patients must have normal organ and marrow function as defined below:

- Leukocytes: =3,000/ cells per microliter of blood (mcL)

- Absolute neutrophil count: =1,500/mcL

- Platelets: =100,000/mcL

- Total bilirubin: within normal institutional limits

- aspartate aminotransferase (AST) (SGOT)/alanine aminotransferase (ALT) (SGPT):
=2.5 × institutional upper limit of normal

- Creatinine: within normal institutional limits OR

- Creatinine clearance: =60 mL/min/1.73 m2 for patients with creatinine levels
above institutional normal.

Exclusion Criteria:

- Patients with diffuse subependymal or cerebral spinal fluid (CSF) disease.

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

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

- Patients who are known HIV, Hepatitis B or Hepatitis C positive. HIV-positive patients
on combination antiretroviral therapy are ineligible because of the potential for
pharmacokinetic interactions with topotecan. In addition, these patients are at
increased risk of lethal infections when treated with marrow-suppressive therapy.
Appropriate studies will be undertaken in patients receiving combination
antiretroviral therapy when indicated.

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

- Patients who have previously received systemic topotecan for their tumor

- Patients who are not able to receive an MRI scan.

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to topotecan, other topoisomerase inhibitors or gadolinium compounds.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03154996      |      Link to official Clinicaltrials.gov listing
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