Trial Information

Summary: A Phase I Study of 17-AAG in Relapsed / Refractory Pediatric Patients with Solid Tumors or Leukemia

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

• To test the safety of 17-AAG
• To see what effects (good and bad) it has on children and children's cancer
• To find the highest dose of 17-AAG that can be given to children without causing severe side effects
• To learn how the body handles the drug
• To better understand how the drug affects tumor cells differently from healthy cells

Who will be included in this study?
Patients with any leukemia or solid tumor (except brain stem tumors) who are 1 to 21 years old may be eligible to participate in this clinical trial.

What is involved?
Patients may be in the study for up to 12 months if they are responding to therapy.

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

• Medical history
• Physical exam
• Vital signs (blood pressure, pulse, temperature)
• Blood tests
• Urine tests
• Pregnancy test for females of childbearing age
• X-rays, CT scans, or other tests(for solid tumors)
• Bone marrow test (for a leukemia or a solid tumor that involves the bone marrow)

The following tests are all necessary to make sure that patients are not having unsafe side effects and to see whether or not the tumor is responding to 17-AAG:

• Physical exam
• Blood tests
• X-rays, CT scans, or other tests that are needed to check the tumor
• Bone Marrow tests for patients with leukemia or patients with a solid tumor that involves the bone marrow

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. 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 the 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.