Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00038207|
Recruitment Status : Completed
First Posted : May 30, 2002
Last Update Posted : October 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma Lymphoma Leukemia Wilms' Tumor Osteosarcoma||Drug: Liposomal Vincristine||Phase 2|
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 MRI/CT test. These are needed to measure the patient's 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 and/or 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. Patient's 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies|
|Study Start Date :||June 2000|
|Actual Primary Completion Date :||September 2004|
|Actual Study Completion Date :||September 2005|
|Experimental: Liposomal Vincristine||
Drug: Liposomal Vincristine
Vincristine Sulfate Liposome Injection (VSLI) administered via a central venous catheter at 2.0 mg/m2 over 60 minutes every 14 days + 2 days
Other Name: Vincristine Sulfate Liposome
- Number of Patients with Response [ Time Frame: 3 Months post initiation of treatment ]Response defined as Complete Response or Partial Response.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00038207
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Cynthia E. Herzog, MD, BA||UT MD Anderson Cancer Center|