This study will collect blood and urine samples from patients undergoing radiation
therapy for glioblastoma multiforme (a type of brain tumor) to investigate the effects of
this treatment on blood cells and certain proteins. The information from this study may
help scientists develop new tests to measure radiation exposure and find new ways to
treat cancer with radiation, and help determine which kinds of patients or tumors respond
better to radiation therapy. Two proteins of particular interest in this study and which
may be involved in the recurrence of cancer are VEGF (vascular endothelial growth factor)
and MMPs (matrix metalloproteinases).
Patients 18 years of age and older with glioblastoma multiforme who are receiving or will
receive radiation therapy as part of their medical treatment may be eligible for this
study. Candidates are screened with a history and physical examination, blood tests, and
magnetic resonance imaging (MRI) of the brain.
Participants will have blood and urine samples collected before, during and after
completion of their radiation treatment. Urine samples are collected in a cup and about 2
tablespoons of blood are withdrawn through a needle in a vein. Additional samples may be
requested at different times during treatment and in the 3-year follow-up period.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT00083512.
Locations matching your search criteria
United States
Maryland
Bethesda
National Institutes of Health Clinical CenterStatus: Active
Contact: National Cancer Institute Referral Office
Phone: 888-624-1937
BACKGROUND
- Preliminary data generated from our pilot protocol 02-C-0064 suggests that the
urinary VEGF and MMP level at the one month follow-up time point compared to the
last on-treatment time point collection may be predictive of tumor recurrence at one
year.
- Note that this preliminary study included patients with all histologies.
- In an ongoing effort to validate our results with a larger more homogeneous patient
cohort we propose to prospectively study patients undergoing radiotherapy for GBM.
OBJECTIVES
-We will determine whether VEGF and MMP level measurements aid in predicting tumor
recurrence at 1 year.
ELIGIBILITY
-Patients seen in the radiation oncology clinic will be asked to provide samples of blood
and urine before, during and after their radiation treatment.
DESIGN
- This protocol-provides a means of acquiring blood and urine samples from patients
receiving radiation therapy for Glioblastoma multiforme (GBM).
- Patients will be analyzed according to their Radiation Therapy Oncology Group (RTOG)
recursive partitioning prognostic subgroups, which includes patient age, KPS, extent
of resection and neurological function.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationNational Cancer Institute
Principal InvestigatorKevin Camphausen
