Trial Information

Summary: A Phase I Study of Depsipeptide in Pediatric Patients with Refractory Solid Tumors and Leukemias

What is the purpose of this study?
The goals of this research study are:

• To test the safety of depsipeptide and see what effects (good and bad) it has on children and children's cancer
• To find the highest dose of depsipeptide that can be given to children with solid tumors without causing severe side effects
• To learn how the body handles the drug depsipeptide and to assess the effects of depsipeptide on tumor cells and gene expression
• To find out if the highest dose of depsipeptide in children with solid tumors is also safe for children with leukemia

Who will be included in this study?
Patients who are younger than 22 years old with solid tumors, either extracranial solid tumors or brain tumors, may be eligible to participate in this clinical trial.

What is involved?
Patients will be in the study for a minimum of 28 days (one course of drug).

Before patients can participate in this study, they will take part in a screening process that will include:

• Medical history
• Physical examination
• Vital signs (blood pressure, pulse, temperature)
• Blood tests
• Urine tests
• Scans of the tumor (the doctor will determine the best type of scan, e.g., CT scan or MRI to evaluate the tumor)
• Pregnancy test (if participant is a female old enough to have children)
• Studies to evaluate heart function, such as an ECG and ultrasound
• Test on the bone marrow (for patients who have leukemia or a tumor that involves the bone marrow)
• Additional tests may be obtained if the doctor feels that they are indicated

Patients will also have a series of tests to make sure that depsipeptide has no bad effect on the heart:

• Blood tests
• ECG tests
• Patients will wear a Holter monitor while receiving the first dose of depsipeptide and for about 24 hours after receiving the first dose

What are the benefits?
Patients may receive no direct benefit from participating in this study. The biggest benefit is that they may be helping other children and adults. Clinical studies are essential in finding new and improved treatments and diagnostic tools.

Will I get all the facts about the study?
Parents interested in having their child participate, and adult patients, will be given a consent form that thoroughly explains all of the details of the study. It goes over all of the procedures, the risks, the benefits, the compensation, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent/guardian or an adult patient has signed this form and, if of age, a child patient has given at minimum his/her verbal agreement.

What are the risks?
A detailed list of side effects can be provided to those patients or parents interested in knowing more about the study.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.