A Phase I Study of CEP-701 in Patients with Refractory Neuroblastoma
What is the purpose of this study?
The goals of this research study are:
- To find the highest dose of CEP-701 that can be given twice a day Monday through Friday without causing severe side effects
- To find out the side effects seen with giving CEP-701 on this schedule at different dose levels
- To measure blood levels of CEP-701 during treatment and to see if the drug at these levels can kill neuroblastoma cells in a test tube or in the bone marrow
- To determine if the tumor gets smaller after treatment with CEP-701
Who will be included in this study?
Patients with neuroblastoma who are ≤ 2I years of age are eligible to participate in this clinical trial.
What is involved?
Patients will receive treatment on this study every 28 days for as long as the neuroblastoma responds to the treatment or patients do not have bad side effects from taking CEP-701. After patients stop treatment with CEP-701, they will continue to have tests and scans done to measure how much tumor is left.
Medical tests before and during treatment:
- Physical exam
- Bone marrow tests
- Blood tests
- Various scans
- Pregnancy test
- Test of heart function (before starting treatment only)
- Urine tests
Medical tests following treatment:
- Physical exam
- Various scans
- Blood tests
- Test of heart function
- Bone marrow tests
- Urine tests
What are the benefits?
Your child may receive no direct benefit from participating in this study. The biggest benefit is that your child 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 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 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.
Who should I contact for more information?
Peggy Kaiser, RN, BSN
Cincinnati Children's Hospital Medical Center
Division of Hematology/Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799
cancer@cchmc.org
