Phase II Liposomal Vincristine for Pediatric and Adolescent Patients With Relapsed Malignancies
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients with Response
Response defined as Complete Response or Partial Response.
3 Months post initiation of treatment
Cynthia E. Herzog, MD, BA
UT MD Anderson Cancer Center
United States: Food and Drug Administration
|UT MD Anderson Cancer Center||Houston, Texas 77030|