Trial Information

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

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

• To test the safety of depsipeptide
• To 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 without causing severe side effects
• To learn how the body handles the drug depsipeptide
• To assess the effects of depsipeptide on tumor cells and gene expression

Who will be included in this study?
Patients who are less than 22 years of age with solid tumors, either extracranial solid tumors or brain tumors, are 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 (for females old enough to have children)
• Studies to evaluate heart function, such as an ECG and ultrasound
• Test on 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
• EKG tests
• Patients will wear a Holter monitor while receiving the first dose of depsipeptide and for about 24 hours after receiving the first dose
• MUGA scan will be performed

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 adult patient has signed this form and, if of age, the child has given at minimum his/her verbal agreement.

What are the risks?
A detailed list of side effects can be provided to those patients 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.