Detection of Glioblastoma or Anaplastic Astrocytoma Cells in the Circulation During Surgical Resection
N/A
N/A
Both
Astrocytoma, Glioblastoma, Glioma
Trial Information
Detection of Glioblastoma or Anaplastic Astrocytoma Cells in the Circulation During Surgical Resection
Glioblastomas are the most frequent malignant brain tumor in adults and are widespread in
the brain despite their discrete appearance on CT or MRI. While locally aggressive,
metastasis of glioblastoma to extracranial organs is considered rare. Approximately 10% of
patients with glioblastoma develop metastatic disease after radiation or craniotomy. Few
patients have developed extracranial metastatic disease in the absence of surgical resection
or radiation. Unlike tumors of other organs such as lung, colon and prostate, the presence
of glioma cells in the circulation of patients undergoing surgical resection has not been
established. If found absent, glioma cells may be unable to intravasate through the blood
brain barrier. If present, these tumor cells presumably can intravasate but may be
recognized and eliminated by an immunological process, or they may escape detection yet not
be able to take hold in the new microenvironment. The information provided will add to the
knowledge of the biology of these highly malignant tumors.
Inclusion Criteria
INCLUSION CRITERIA:
Patients must be diagnosed with biopsy-proven glioblastoma multiforme or anaplastic
astrocytoma (WHO grade III and IV, WHO classification of glial tumors) and meet the
following criteria:
Consenting males and females between the ages of 18 and 75, inclusive.
Provided written informed consent prior to participation in the trial.
Karnofsky Performance Scale Score greater than or equal to 60.
Patients of all races and sexes are eligible for this study. Children and adolescents
only rarely are afflicted with gliomas that are amenable for surgical resection, and so
are excluded from this study.
Patients who have been accepted for glioma resection under existing NINDS protocols are
also eligible for this study.
If tumor tissue is available from biopsy prior to surgery, we will attempt to identify
tumor-specific mutation(s) prior to enrolling the patient.
EXCLUSION CRITERIA:
Clinically unstable condition.
Liver function impairment (total bilirubin greater than 2.0 mg/dl; AST or ALT greater than
3 times the upper limit of normal).
Coagulopathy (prothrombin time [PT] or activated partial thromboplastin time [APTT] > 1.5
times control).
Thrombocytopenia (platelet count less than 100,000/mm3).
Granulocytopenia (absolute neutrophil count less than 1,000/mm3).
Acute infection.
Acute medical problems.
Positive HIV test.
Karnofsky Performance Scale Score less than 60.
Allergy to CT contrast agents.
Absence of tumor-specific gene mutation.
Pregnant women. Women of child-bearing potential will undergo a urine and/or serum
pregnancy test. Women who are pregnant will not be allowed to participate in this study.
Type of Study:
Observational
Study Design:
N/A
Authority:
United States: Federal Government
Study ID:
000009
NCT ID:
NCT00001148
Start Date:
October 1999
Completion Date:
January 2005
Related Keywords:
- Astrocytoma
- Glioblastoma
- Glioma
- Metastasis
- Glioma
- Venous
- Sampling
- p53 Mutation
- Glioblastoma Multiforme
- Circulating Tumor Cells
- Mutation
- Anaplastic Astrocytoma
- Astrocytoma
- Glioblastoma
- Glioma
Name | Location |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | Bethesda, Maryland 20892 |
