View Clinical Trial (Medical Research Study)

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

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Conditions:		Recurrent Anaplastic Astrocytoma - Recurrent Anaplastic Oligodendroglioma - Recurrent Anaplastic Oligo-Astrocytoma - Recurrent Glioblastoma Multiforme
Purpose:		Patients will be hospitalized for a Stereotactic biopsy of the recurrent primary brain tumor and then have placement of two catheters into the recurrent brain tumor. Chemotherapy (Topotecan) will be slowly infused through the catheters over 4-5 days. Patients will be followed with daily MRI scans, neurological assessments and blood work throughout the hospitalization. After hospitalization there will be monthly follow-up visits, which progress to every 2 months visits. MRI scan, neurological assessments and blood work will be done at the follow-up visits.
Study Summary:		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.
Criteria:		Inclusion: - 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 entry. - 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 operation. - 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. Exclusion: - 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 virus - 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
NCT ID:		NCT00452959
Primary Contact:		Principal Investigator Jeffrey N Bruce, M.D. Columbia University Department of Neurosurgery
Backup Contact:		N/A
Location Contact:		New York City, New York 10032 United States There is no listed contact information for this specific location. Site Status: N/A

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