Tamoxifen and Bortezomib to Treat Recurrent Brain Tumors
Status:
Completed
Trial end date:
2013-03-01
Target enrollment:
Participant gender:
Summary
This study will determine whether the drugs tamoxifen and bortezomib can delay tumor growth
in patients with recurrent glioma (malignant brain tumor). Tamoxifen may work by interfering
with the internal signaling needed for the cancer to grow. Bortezomib may also interfere with
tumor growth processes. Laboratory studies show that low doses of bortezomib significantly
enhance glioma cell death when used with tamoxifen.
Patients 18 years of age and older with glioma whose tumor does not respond to standard
medical treatment and who are not taking enzyme-inducing anti-seizure medications such as
Dilantin, phenobarbitol, or Tegretol, may be eligible for this study. Candidates are screened
with a physical examination, blood tests, and magnetic resonance imaging (MRI) or computed
tomography (CT). MRI and CT scans produce images of the brain that can show if the brain
tumor is growing (see below).
Participants receive treatment in 6-week cycles for up to 1 year. (The treatment duration may
be extended in some patients who continue to tolerate the drug and show no signs of tumor
growth after 1 year.) During each cycle, patients take six tamoxifen tablets twice a day
every day and receive bortezomib by infusion into a vein on days 3, 6, 10, 13, 24, 27, 31 and
34. Treatment may continue as long as the tumor does not grow and the patient does not
develop unacceptable side effects. In addition to drug treatment, patients undergo the
following tests and procedures:
- Periodic routine blood tests.
- MRI or CT scan of the head before starting each new cycle. MRI uses a magnetic field and
radio waves to produce images of body tissues and organs. CT uses x-rays to provide
3-dimensional views of the part of the body being studied. For both procedures, the
patient lies on a table that slides into the cylindrical scanner.
- Blood test to measure levels of bortezomib. Blood is drawn before the bortezomib
infusion on days 3 and 24, and 4 hours after the infusion on day 24 of the first
treatment cycle only.
- Dynamic MRI with spectroscopy or positron emission tomography (PET). Patients may be
asked to undergo one of these tests, which help distinguish live tumor from dying tumor.
The experience of dynamic MRI with spectroscopy is the same as standard MRI and is done
at the same time as the standard procedure (see above). PET uses a radioactive substance
to show cellular activity in specific tissues of the body. The patient is given an
injection of a sugar solution in which a radioactive isotope has been attached to the
sugar molecule. A special camera detects the radiation emitted by the radioisotope, and
the resulting images show how much glucose is being used in various parts of the body.
Because rapidly growing cells, such as tumors, take up and use more glucose than normal
cells do, this test can be used to show active tumors.
- Drug diary. Patients maintain a calendar to record when they take their study drugs and
what side effects they develop.