Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies
Soft Tissue Sarcoma
Drug: Liposomal Vincristine
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies|
- Number of Patients with Response [ Time Frame: 3 Months post initiation of treatment ] [ Designated as safety issue: No ]Response defined as Complete Response or Partial Response.
|Study Start Date:||June 2000|
|Study Completion Date:||September 2005|
|Primary Completion Date:||September 2004 (Final data collection date for primary outcome measure)|
|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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|