Trial Information

Summary: A Phase 1 Study of SAHA in Pediatric Patients with Recurrent or Refractory Solid Tumors (Including Lymphomas) and Leukemia Followed by a Phase I Study of SAHA in Combination with 13 Cis-Retinoic Acid for Patients with Selected Recurrent/Refractory Solid Tumors

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

• To find the highest safe dose of SAHA that can be given without causing severe side effects in patients with solid tumors
• To learn if the highest safe dose of SAHA is also a safe dose for patients with leukemia
• To find the highest safe dose of SAHA that can be given with 13-cis RA
• To learn what kind of side effects SAHA (or the combination of SAHA and 13-cis RA) can cause
• To learn more about the pharmacology (how the body handles the drug) of SAHA
• To learn more about the effect SAHA has on certain biological processes
• To learn more about the relationship between genes and whether or not SAHA is a beneficial treatment for tumors (pharmacogenetic studies)
• To determine whether SAHA, given alone or in combination with 13-cis RA, is a beneficial treatment for tumors

Who will be included in this study?
Patients who are older than 12 months or younger than 22 year old at study entry who have a recurrent or progressive tumor or leukemia that cannot be cured by any known standard of treatment may be eligible to participate in this clinical trial.

What is involved?
Patients may be in the study for up to 12 months, as long as they are responding to therapy, or the cancer is not getting worse. For about a month after patients are finished taking the study drug(s), the study doctor will ask them to visit the office for follow-up exams.

Standard Medical Tests
Before the study begins
Patients will need to have the following exams, tests, or procedures to find out if they can be in the study. These exams, tests, or procedures are part of regular cancer care and may be done even if patients do not join the study. If some tests have been performed recently, they may not need to be repeated. This will be up to the study doctor.

• A medical history
• Physical exam
• Vital signs (blood pressure, pulse, temperature)
• Blood tests
• Urine tests
• Echocardiogram to test heart function
• Pregnancy test (for women of childbearing age)
• X-rays, CT scans, or other tests are needed to check the tumor

During the study
Patients will also be given the following tests and procedures during the study. They are part of regular cancer care:

• Physical exam
• Blood tests
• Tests to evaluate the tumor (the doctor will decide which test to use)
• Optional research studies

What are the benefits?
There may be no direct benefit for participants who agree to take part in this research study. It is unlikely that patients will experience significant benefit or cure from this drug, SAHA. The potential benefit of the treatment with SAHA is that it may cause the cancer to stop growing or to shrink for a period of time. It may lessen the symptoms, such as pain, that are caused by the cancer. Because there is not much information about the effects of SAHA and the combination of SAHA and 13-cis-RA in humans, we do not know if patients will benefit from taking part in this study. The knowledge gained from this study may benefit others. The disease may continue to become worse despite taking this drug.

Will I get all the facts about the study?
Parents interested in having their child participate, as well as adult patients/subjects, will be scheduled with a physician who will thoroughly explain all of the details of the study. The physician will review the consent form with the parent/guardian/adult subject and will be sure that all questions are answered. The consent form goes over all of the procedures, the risks, the benefits, the compensation, who to contact with questions or concerns and more. Study procedures will not begin until a parent/guardian or adult subject 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 will 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.