Depsipeptide to Treat Thyroid and Other Advanced Cancers
Status:
Completed
Trial end date:
2010-04-01
Target enrollment:
Participant gender:
Summary
This phase I study will evaluate the experimental drug Romidepsinin patients with advanced
cancer. The study will: 1) determine how well patients tolerate Romidepsin; 2) measure blood
levels of Romidepsin during treatment; 3) analyze the cellular and molecular effects of the
drug; and 4) determine if Romidepsin can shrink tumors. Romidepsin has been shown to kill
cancer cells growing in the laboratory and to shrink tumors in animals with various tumor
types. In preliminary studies, several patients with a type of lymphoma and one patient with
kidney cancer responded to treatment.
Patients 18 years of age and older with advanced cancer (excluding acute leukemia) may be
eligible for this study. Candidates are screened with a medical history and physical
examination, x-rays and CT scans, and blood and urine tests. Patients with thyroid cancer may
also have magnetic resonance imaging (MRI). This test uses a magnetic field instead of x-rays
to obtain images or body organs and tissues.
Participants receive three infusions of Romidepsin administered through an intravenous line
over 4 hours on days 1, 3 and 5 of a 21-day treatment cycle. The intravenous line is a
catheter (plastic tube) placed in a vein and may be a peripheral line, inserted in a vein in
the arm, or a central line, in which the tube is placed under the skin of the chest or neck
into a major vein. Patients are hospitalized for the first 6 days of the first cycle to
monitor heart rate. Those who tolerate the treatment well may continue as an outpatient.
In addition to drug therapy, participants undergo the following procedures:
- Blood tests: Small amounts of blood are drawn frequently during the first five days of
treatment to measure Romidepsin levels and to see how the body uses and excretes the
drug. A heparin lock (an indwelling device to keep the vein open) may be put in the vein
to prevent the need for repeated needle sticks.
- Biopsies (removal of a small sample of tumor tissue): Tumors that are accessible may be
biopsied at the start of the study and at different times during treatment. Biopsies are
done no more than three times per cycle, and no more than nine biopsies are done within
a year. The samples are examined for the effects of Romidepsin on proteins that control
the way cells divide and stay alive.
- Apheresis: This procedure is done to collect white blood cells and cancer cells for
research. Blood is collected through a needle in an arm vein and directed into a machine
that separates it into its components by centrifugation (spinning). The white cells are
removed and the red cells are returned to the patient through the same needle or through
another needle in the other arm.
- Scans and x-rays: Imaging studies are usually done before starting treatment. Some of
them are repeated at every 2 cycles (6 weeks), and some at the end of the patient's
participation in the study. The tests may include chest x-rays, plain x-rays of affected
bones, CT scans of the chest, abdomen, and pelvis, bone scans, and a MUGA scan (special
X-ray of the heart) or echocardiogram (ultrasound of the heart) to test heart function
before and during the study. MRI or positron emission tomography (PET) scans may also be
done to detect tumors. PET scans use a small amount of a radioactive substance injected
into a vein. The radioactivity is detected by a special camera during scanning to detect
cancer cells.
- Other tests include an electrocardiogram (recording of the electrical activity of the
heart) before and after each dose of depsipeptide. Eye exams are done if there are
vision changes or if the doctor recommends an eye test.