ANBL0621: A Phase II Study of ABT-751, an Orally Bioavailable Tubulin Binding Agent, in Children with Relapsed or Refractory Neuroblastoma
What is the purpose of this study?
The goals of this research study are:
- Find out if ABT-751 keeps disease from getting worse in patients with relapsed or progressive neuroblastoma when compared to patients who have been treated on previous experimental studies
- Find out if neuroblastoma tumors that can be seen on MIBG, CT or MRI scans will get smaller when ABT-751 is given
- Examine how you feel physically and emotionally (Quality of Life) before and during treatment with ABT-751
- Learn more about the side effects of the experimental drug, ABT-751
- Learn more about how the body handles the ABT-751 liquid preparation in children (this is called a pharmacokinetic study)
- Find out how ABT-751 affects the blood flow to neuroblastoma tumors by performing a special type of scan called a Dynamic Contrast Enhanced MRI Scan (DCEMRI) before and on day 5 (± 2 days) of cycle 1
Who will be included in this study?
Patients with neuroblastoma who are less than 22 years of age are eligible to participate in his clinical trial.
What is involved?
Patients in this clinical trial are expected to receive treatment on this study for at least one course or 21 days. As long as the cancer is not growing or getting smaller, patients can continue to take ABT-751 for about 3 years. After treatment, patients will have follow-up examinations and medical tests. We will continue to collect some medical information from patients for 5 years after the last patient starts the study.
Before patients can participate in the study, they will need to have the following exams, tests or procedures to find out if they can be in the study. These are part of regular cancer care and may be done even if they do not join the study. These screening tests must be done within 1 week of starting this study and include:
- A medical history
- Physical examination, including vital signs (blood pressure, pulse, temperature), height and weight
- Blood tests
- Urine tests
- Pregnancy test (for females who can have children)
- Urine for VMA/HVA (substances that are sometimes secreted by neuroblastoma tumors)
- Echocardiogram (a test to see how well your heart is working)
- Bilateral bone marrow aspiration and biopsy. Bilateral means the aspirate and biopsy will be taken on both sides of the hip
- Scans to evaluate the tumor (the doctor will determine the best type of scan, e.g. CT scan or MRI)
What are the benefits?
If patients agree to take part in this research study, there may not be a direct medical benefit. Potential benefits for patients may include their tumor getting smaller and less time in the hospital, since this is an oral medicine. The information learned from this research study may benefit other patients with neuroblastoma in the future.
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 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 patients interested in knowing more about the study.
Who should I contact for more information?
Rebecca Turner, MS, CCRP
Cincinnati Children's Hospital Medical Center
Division of Hematology / Oncology
3333 Burnet Ave., Cincinnati, OH 45229-3039
Phone: 513-636-2799
cancer@cchmc.org
