Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00523939
Status:
TERMINATED
Last Update Posted:
2013-06-17
First Post:
2007-08-31
Brief Title:
DepoCyt for Active Lymphomatous or Leukemic Meningitis
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Phase II Study of Intrathecal Therapy With DepoCyt for Active Lymphomatous or Leukemic Meningitis
Status:
TERMINATED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the response rate of lymphomatous meningitis or leukemic meningitis to DepoCyt The safety of DepoCyt the number of people who respond well to the study drug and the response of symptoms to the study drug will also be determined
Detailed Description:
DepoCyt is a sustained-release formulation of the chemotherapy drug cytarabine Ara-C which is used for the treatment of patients with lymphomatous or leukemic meningitis a complication of lymphomaleukemia that is characterized by the spread of cancer to the central nervous system
DepoCyt is introduced into the spinal fluid through a needle inserted into the spinal canal or through a reservoir placed under the scalp by a neurosurgeon DepoCyt will be given every two weeks ie week 1 and week 3 initially After the second dose a lumbar puncture will be done to check the spinal fluid for cancer cells If there has been a good response DepoCyt will be given every 14 days for 6 doses ie weeks 5 7 9 11 13 15 and then every 28 days for six doses ie weeks 19 23 27 31 35 and 39 Blood tests and lumbar punctures will be done throughout the study
DepoCyt is introduced into the spinal fluid through a needle inserted into the spinal canal or through a reservoir placed under the scalp by a neurosurgeon DepoCyt will be given every two weeks ie week 1 and week 3 initially After the second dose a lumbar puncture will be done to check the spinal fluid for cancer cells If there has been a good response DepoCyt will be given every 14 days for 6 doses ie weeks 5 7 9 11 13 15 and then every 28 days for six doses ie weeks 19 23 27 31 35 and 39 Blood tests and lumbar punctures will be done throughout the study
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