Phase 1 Intrathecal Topotecan for Neoplastic Meningitis (PBTC-019)
|ClinicalTrials.gov Identifier: NCT00674674|
Recruitment Status : Completed
First Posted : May 8, 2008
Last Update Posted : May 15, 2012
- To find the optimal dose of topotecan that can safely be given directly into the spinal fluid (called intrathecal administration) of children whose cancer has spread to the lining of the brain and/or spinal cord.
To find out what effects (good and bad) topotecan has when given directly into the cerebrospinal fluid in children with neoplastic meningitis (cancer that has spread to the lining of the brain and spinal cord).
- Cerebrospinal fluid is the fluid that circulates around the brain and spinal cord.
- To determine if intrathecal topotecan is beneficial to patients.
- To better understand how topotecan is handled by the body after intrathecal administration.
- To evaluate the cerebrospinal fluid for signs (markers) of tumor spread.
|Condition or disease||Intervention/treatment||Phase|
|Neoplastic Meningitis||Drug: Topotecan||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Phase I Pharmacokinetic Optimal Dosing Study of Intrathecal Topotecan for Children With Neoplastic Meningitis|
|Study Start Date :||October 2005|
|Primary Completion Date :||August 2010|
|Study Completion Date :||December 2010|
Induction (4 weeks): Patients will receive IT topotecan for 5 consecutive days during weeks 1 and 3.
The Induction period is the first 4 weeks of therapy.
- To estimate the MTD of intrathecal topotecan administered daily for 5 consecutive days. [ Time Frame: 14 days ]
- To describe the toxicities and define the dose-limiting toxicity of intrathecally administered topotecan following intraventricular administration daily for 5 consecutive days. [ Time Frame: 30 days ]
- To determine if the MTD of intrathecal topotecan is also a pharmacokinetic optimal dose as defined by topotecan lactone concentrations in the cerebral CSF. [ Time Frame: 7 days ]
- To provide preliminary descriptions of the anti-tumor activity of intraventricular topotecan observed in the heterogeneous diseases that will be treated in this trial. [ Time Frame: 2 years ]
- To investigate MMP, VEGF, and other potential biological markers in the CSF of patients with neoplastic meningitis prior to and throughout treatment with intrathecal topotecan. [ Time Frame: 2 years ]
- To further describe the CSF pharmacokinetics of topotecan following intrathecal administration. [ Time Frame: 2 years ]
- To investigate the feasibility of central review imaging following treatment and to correlate observed effects with response to intrathecal therapy. [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00674674
|United States, Texas|
|Texas Children's Hospital|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Susan Blaney, MD||Baylor College of Medicine|