Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038207
Status:
COMPLETED
Last Update Posted:
2018-10-31
First Post:
2002-05-29
Brief Title:
Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies
Status:
COMPLETED
Status Verified Date:
2018-10
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:
The goal of this clinical research study is to learn if treatment with the drug liposomal vincristine can shrink or slow the growth of the patients cancer The safety of this drug will also be studied
Detailed Description:
Before and during the treatment patients will have exams done These may include blood tests urine tests bone marrow tests tests of the central nervous system x-rays or MRICT test These are needed to measure the patients clinical condition and progress A physical exam and blood tests about 2 teaspoons will be repeated at least one time weekly
Since Liposomal Vincristine may prevent the body from making andor keeping new blood cells prior to treatment patients will also have a Human Immunodeficiency Virus AIDS virus test a blood test to detect the presence of antibodies to the AIDS virus A separate informed consent will be given to be signed in order to obtain permission for this test Female patients may also be required to have a urine pregnancy test before treatment may begin as it is not known how the drug may affect the unborn child
Patients will receive liposomal vincristine through a central venous catheter a plastic tube usually inserted under the collar bone over one hour once every 14 days 2 days Patients will also be given the drug docusate by the day liposomal vincristine is started This is done to try to prevent constipation as a side effect
All patients who show a continued response or stable disease without major side effects may continue to receive liposomal vincristine for up to 24 months Patients with solid tumors and lymphoma will have X-rays performed every 8 weeks to follow the progression of their tumor Patients with leukemia will have a bone marrow aspirate and biopsy done after the first and second months of treatment and then every 8 weeks
This is an investigational study The FDA has authorized the use of the study drug in research Up to 60 patients will take part in this study Up to 30 patients will be enrolled at UTMDACC
Since Liposomal Vincristine may prevent the body from making andor keeping new blood cells prior to treatment patients will also have a Human Immunodeficiency Virus AIDS virus test a blood test to detect the presence of antibodies to the AIDS virus A separate informed consent will be given to be signed in order to obtain permission for this test Female patients may also be required to have a urine pregnancy test before treatment may begin as it is not known how the drug may affect the unborn child
Patients will receive liposomal vincristine through a central venous catheter a plastic tube usually inserted under the collar bone over one hour once every 14 days 2 days Patients will also be given the drug docusate by the day liposomal vincristine is started This is done to try to prevent constipation as a side effect
All patients who show a continued response or stable disease without major side effects may continue to receive liposomal vincristine for up to 24 months Patients with solid tumors and lymphoma will have X-rays performed every 8 weeks to follow the progression of their tumor Patients with leukemia will have a bone marrow aspirate and biopsy done after the first and second months of treatment and then every 8 weeks
This is an investigational study The FDA has authorized the use of the study drug in research Up to 60 patients will take part in this study Up to 30 patients will be enrolled at UTMDACC
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