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Sponsors and Collaborators: |
Baylor College of Medicine GlaxoSmithKline |
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Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00674674 |
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).
Condition | Intervention | Phase |
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Neoplastic Meningitis |
Drug: Topotecan |
Phase I |
Study Type: | Interventional |
Study Design: | Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Phase I Pharmacokinetic Optimal Dosing Study of Intrathecal Topotecan for Children With Neoplastic Meningitis |
Estimated Enrollment: | 49 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
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.
This is a multi-center, non-randomized pharmacokinetically-guided optimal dosing study of intraventricular topotecan in children with neoplastic meningitis. Topotecan will be administered daily for five consecutive days utilizing the schema shown in the Schema below. Concomitant chemotherapy to control systemic disease or bulk CNS disease is allowable provided that the systemic chemotherapy is not an investigational agent or one of the following: high-dose methotrexate (> 1g/m2), high-dose cytarabine (> 1g/m2), 5-fluorouracil, capecitabine, thiotepa, a nitrosourea, or topotecan. The starting dose for this trial was derived from pharmacokinetic simulations that utilized data from a prior phase I study of intrathecal topotecan. The simulations were performed to estimate the length of time that ventricular CSF concentrations of topotecan lactone would remain above an optimal "target level" of 1 ng/mL. One of the primary objectives of this study is to estimate the dose of intrathecal topotecan that will result in CSF lactone concentrations exceeding 1 ng/mL for at least eight hours after an intrathecal injection. Dose escalations for patient cohorts will be conducted following the traditional phase 1 design in order to determine the maximum tolerated dose (MTD). The MTD will be called pharmacokinetically optimal if that dose achieves the targeted PK parameter in at least 23 of 25 patients treated at that dose level.
Ages Eligible for Study: | 3 Years to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Recovery from Prior Therapy: Patients must have recovered from the acute neurotoxic effects of all prior chemotherapy, biological therapy, immunotherapy, or radiotherapy prior to entering this study and must be without uncontrolled significant systemic illness
5.1 Chemo:
5.2 XRT: Patients must have had their last fraction of craniospinal irradiation greater than or equal to 8 weeks prior to study registration.
The following laboratory values must be assessed within two (2) weeks prior to registration. Laboratory tests should be repeated within 48 hours of beginning therapy, if there has been a significant clinical change.
6.1 Electrolytes:
Exclusion Criteria:
CSF Flow: Patients with clinical evidence of obstructive hydrocephalus are not eligible for this protocol. Patients with compartmentalization of CSF flow, as documented by radioisotope Indium111 or Technetium99-DTPA flow study are not eligible for this protocol. Requirement for CSF flow studies are:
1.1 Solid or CNS tumor patients: Nuclear medicine CSF flow studies are required within 7 days prior to registration in all patients with underlying solid or CNS tumors. Informed consent must be obtained prior to the CSF flow study.
1.2 Leukemia or lymphoma patients: Nuclear medicine CSF flow studies are only required if CSF analysis or an MRI suggests that there may be a blockage to CSF flow. The study must be obtained within 7 days prior to registration. Informed consent must be obtained prior to the CSF flow study.
United States, Texas | |
Texas Children's Hospital | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Susan Blaney, MD | Baylor College of Medicine |
Responsible Party: | Baylor College of Medicine ( Susan Blaney, MD ) |
Study ID Numbers: | H-17990, PBTC-019 |
Study First Received: | December 21, 2007 |
Last Updated: | July 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00674674 |
Health Authority: | United States: Food and Drug Administration |
topotecan pharmacokinetics neoplastic meningitis |
Central Nervous System Infections Central Nervous System Diseases Topotecan Meningitis |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses |
Nervous System Diseases Enzyme Inhibitors Pharmacologic Actions |