NCT00048334

Depsipeptide to Treat Thyroid and Other Advanced Cancers

Completed Phase 1 Last updated 12 December 2019

What this trial tests

Phase 1 trial testing Depsipeptide, FR901228, FK228 in Neoplasms in 28 participants. Completed in 1 April 2010.

Timeline

26 October 2002

Primary endpoint
1 April 2010

1 April 2010

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Primary purpose	treatment
Enrollment	28
Start date	26 October 2002
Primary completion	1 April 2010
Estimated completion	1 April 2010
Sites	1 location across United States

Drugs / interventions tested

• Depsipeptide, FR901228, FK228 — full drug profile →

Conditions studied

• Neoplasms — all drugs for Neoplasms →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Trials with 'epigenetic' drugs: an update.
   Nebbioso A, Carafa V, Benedetti R, Altucci L. · · 2012 · cited 162× · PMID 23103179 · DOI 10.1016/j.molonc.2012.09.004
2. Phase I trial of a new schedule of romidepsin in patients with advanced cancers.
   Amiri-Kordestani L, Luchenko V, Peer CJ, Ghafourian K, et al · · 2013 · cited 45× · PMID 23757352 · DOI 10.1158/1078-0432.ccr-13-0095
3. Repeated measures dose-finding design with time-trend detection in the presence of correlated toxicity data.
   Yin J, Paoletti X, Sargent DJ, Mandrekar SJ. · · 2017 · cited 6× · PMID 28764555 · DOI 10.1177/1740774517723829
4. Epigenetic modifications in follicular cell-derived thyroid cancer: new dimensions in pathogenesis and treatment.
   Han Y, Wu B, Tan J, Wu R, et al · · 2025 · cited 2× · PMID 40463874 · DOI 10.3389/fonc.2025.1549477