Intracerebral Clysis in Treating Patients With Recurrent Primary Brain Tumors
This study is ongoing, but not recruiting participants.
Sponsor:
Jeffrey N. Bruce
Collaborators:
Herbert Irving Comprehensive Cancer Center
Information provided by (Responsible Party):
Jeffrey N. Bruce, Columbia University
ClinicalTrials.gov Identifier:
NCT00452959
First received: March 27, 2007
Last updated: February 14, 2013
Last verified: February 2013
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Recurrent Anaplastic Astrocytoma Recurrent Anaplastic Oligodendroglioma Recurrent Anaplastic Oligo-Astrocytoma Recurrent Glioblastoma Multiforme |
Drug: Topotecan |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I/II Study of Topotecan by Intracerebral Clysis for the Treatment of Recurrent Primary Malignant Brain Tumors |
Resource links provided by NLM:
Further study details as provided by Columbia University:
Primary Outcome Measures:
- Time to tumor progression [ Time Frame: treatment to tumor progression ] [ Designated as safety issue: No ]
- Time to death [ Time Frame: treatment to time of death ] [ Designated as safety issue: Yes ]
| Enrollment: | 18 |
| Study Start Date: | October 2003 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Topotecan
Dose escalation
|
Drug: Topotecan
The starting dose will be 0.02 mg/ml, and the second step will escalate the dosage by 100% (0.04 mg/ml); the third step is 67% greater than the second (0.0667 mg/ml); the fourth step is 50% greater than the third (0.1 mg/ml); and each subsequent step is 33% greater than that preceding it (5th step= 0.133; 6th step= 0.178; 7th step=0.237 mg/ml). The total volume of treatment will be 40 mL which is the volume used in previous human trials with ICC.
Other Name: Topotecan
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 1 Year and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452959
Locations
| United States, New York | |
| Columbia University Department of Neurosurgery | |
| New York City, New York, United States, 10032 | |
Sponsors and Collaborators
Jeffrey N. Bruce
Herbert Irving Comprehensive Cancer Center
Investigators
| Principal Investigator: | Jeffrey N Bruce, M.D. | Columbia University Department of Neurosurgery |
More Information
Publications:
B ruce, JN.,A. Falavigna, J.P. Johnson, J. Hall, B.d. Birch, J.T. Yoon, E.X.Wu, R.L. Fine, and A.T. Parsa, Intracerebral cylsis in a rat glioma model. Neurosurgery, 2000. 46(3): P. 683-691. Burris, H.A., 3rd, Topotecan: Incorporating It Into the Treatment of Solid Tumors. Oncologist, 1998. 3(1): p.1-3. Kaiser, M.G., A.T. Parsa, R.L. Fine, J.S. Hall, I. Chakrabarti, and J.N. Bruce, Tissue distribution and antitumor activity of topotecan delivered by intracerebral clysis in a rat glioma model. Neurosurgery, 2000. 47(6): p.1391-1399.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jeffrey N. Bruce, Edgar M. Housepian Professor of Neurological Surgery Research, Columbia University |
| ClinicalTrials.gov Identifier: | NCT00452959 History of Changes |
| Obsolete Identifiers: | NCT00324844 |
| Other Study ID Numbers: | AAAA4229 (I/II), R01CA089395 |
| Study First Received: | March 27, 2007 |
| Last Updated: | February 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Columbia University:
|
Brain Tumors Intracerebral Clysis Topotecan MRI |
Additional relevant MeSH terms:
|
Astrocytoma Brain Neoplasms Glioblastoma Oligodendroglioma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Central Nervous System Neoplasms |
Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Topotecan Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013