Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074607
Status:
TERMINATED
Last Update Posted:
2012-11-12
First Post:
2003-12-16
Brief Title:
Intrathecal Gemcitabine to Treat Neoplastic Meningitis IT Gemcitabine
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Intrathecal Gemcitabine Therapy for Neoplastic Meningitis A Phase I and Pharmacokinetic Study
Status:
TERMINATED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Subjects are being asked to take part in this study because he or she has a type of cancer that has spread to the meninges tissues that cover the brain and spinal cord
There is no known effective treatment for this specific disease or the subject has received all of the treatments that are known to work for his or her specific disease without success Currently there is no other effective treatment for this type of cancer
The purposes of this study are
to determine the highest dose of gemcitabine an anti-cancer drug that can safely be given directly into the spinal fluid of children and adults whose cancer no longer responds to standard treatment
to find out what effects good and bad gemcitabine has when given directly into the cerebrospinal fluid called intrathecal administration in children and adults with neoplastic meningitis cancer that has spread to the lining of the brain and spinal cord
to determine if gemcitabine is beneficial to the patient
to understand how gemcitabine is handled by the body after intrathecal administration
There is no known effective treatment for this specific disease or the subject has received all of the treatments that are known to work for his or her specific disease without success Currently there is no other effective treatment for this type of cancer
The purposes of this study are
to determine the highest dose of gemcitabine an anti-cancer drug that can safely be given directly into the spinal fluid of children and adults whose cancer no longer responds to standard treatment
to find out what effects good and bad gemcitabine has when given directly into the cerebrospinal fluid called intrathecal administration in children and adults with neoplastic meningitis cancer that has spread to the lining of the brain and spinal cord
to determine if gemcitabine is beneficial to the patient
to understand how gemcitabine is handled by the body after intrathecal administration
Detailed Description:
WHAT IS INVOLVED IN THE STUDY Before participating in this study there will be a screening process
Administration
Gemcitabine will be received directly into the cerebrospinal fluid fluid that circulates around the brain and spinal cord through an Ommaya reservoir or other similar type of reservoir An Ommaya reservoir is a surgically implanted catheter that is used to inject medication or to withdraw cerebrospinal fluid from the fluid chambers in the head
All patients will be hospitalized overnight following their first dose of gemcitabine If the first dose is well tolerated further doses of gemcitabine will be administered in the outpatient clinic with close observation for a minimum of 2 hours after administration
Weeks 1-6 Cohort 1a first three patients
Gemcitabine will be given once a week for 6 weeks Patients may continue therapy if the disease has not worsened
Weeks 1-6 all other patients enrolled on this study
Gemcitabine will be given twice a week for 6 weeks Patients may continue therapy if the disease has not worsened
Weeks 7-12
Gemcitabine will be given once a week for 6 weeks
Weeks 13-29 approximately
Gemcitabine will be given twice monthly for 4 months
Weeks 30-52 approximately
Gemcitabine will be given monthly for the duration of the study
For safety reasons the first patients treated in the study will receive a low dose of gemcitabine If that dose does not cause severe side effects the next group will receive a higher dose of gemcitabine than given to the earlier group or may receive a lower dose if side effects occur In addition the first three patients treated on this study will receive the gemcitabine once weekly If this is tolerated subsequent patients will receive the medication twice weekly
Following the first dose of gemcitabine investigators would like to draw special blood and spinal fluid samples to help learn how much of the drug is in the blood and spinal fluid These studies are called pharmacokinetics A total of 10 samples will be collected The blood samples may be collected from an intravenous catheter or a central venous catheter The spinal fluid samples may be collected either via Ommaya reservoir or lumbar reservoir
In addition to intrathecal gemcitabine the patient may receive other chemotherapy not given directly into the fluid surrounding the brain and spine as recommended by his or her doctor for the treatment or prevention of cancer outside the lining of the brain and spinal cord
The maximum length of treatment with gemcitabine is one year However at the end of the study monthly check-ups are required to monitor the disease and to make sure that any side effects from the study drug have stopped
Administration
Gemcitabine will be received directly into the cerebrospinal fluid fluid that circulates around the brain and spinal cord through an Ommaya reservoir or other similar type of reservoir An Ommaya reservoir is a surgically implanted catheter that is used to inject medication or to withdraw cerebrospinal fluid from the fluid chambers in the head
All patients will be hospitalized overnight following their first dose of gemcitabine If the first dose is well tolerated further doses of gemcitabine will be administered in the outpatient clinic with close observation for a minimum of 2 hours after administration
Weeks 1-6 Cohort 1a first three patients
Gemcitabine will be given once a week for 6 weeks Patients may continue therapy if the disease has not worsened
Weeks 1-6 all other patients enrolled on this study
Gemcitabine will be given twice a week for 6 weeks Patients may continue therapy if the disease has not worsened
Weeks 7-12
Gemcitabine will be given once a week for 6 weeks
Weeks 13-29 approximately
Gemcitabine will be given twice monthly for 4 months
Weeks 30-52 approximately
Gemcitabine will be given monthly for the duration of the study
For safety reasons the first patients treated in the study will receive a low dose of gemcitabine If that dose does not cause severe side effects the next group will receive a higher dose of gemcitabine than given to the earlier group or may receive a lower dose if side effects occur In addition the first three patients treated on this study will receive the gemcitabine once weekly If this is tolerated subsequent patients will receive the medication twice weekly
Following the first dose of gemcitabine investigators would like to draw special blood and spinal fluid samples to help learn how much of the drug is in the blood and spinal fluid These studies are called pharmacokinetics A total of 10 samples will be collected The blood samples may be collected from an intravenous catheter or a central venous catheter The spinal fluid samples may be collected either via Ommaya reservoir or lumbar reservoir
In addition to intrathecal gemcitabine the patient may receive other chemotherapy not given directly into the fluid surrounding the brain and spine as recommended by his or her doctor for the treatment or prevention of cancer outside the lining of the brain and spinal cord
The maximum length of treatment with gemcitabine is one year However at the end of the study monthly check-ups are required to monitor the disease and to make sure that any side effects from the study drug have stopped
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IT Gemcitabine | OTHER | Baylor College of Medicine | None |