A Phase I Trial of the Monoclonal Antibody HGS-ETR2 (Lexatumumab) in Patients with Refractory Pediatric Solid Tumors
What is the purpose of this study?
The goals of this study are:
- To determine the highest dose of HGS-ETR2 that can be given safely in children and young adults with cancer
- To study the pharmacology (how your body handles the drug) by measuring the amount of drug in the bloodstream over time prior to and after doses of HGS-ETR2
- To determine if HGS-ETR2 can inhibit the growth of your cancer
- To determine whether proteins present in the tumor tissue before treatment can predict whether your tumor will respond to HGS-ETR2
Who will be included in this study?
Patients who are older than 12 months and younger than 22 years old at study entry who have a recurrent or progressive tumor that has failed to respond to previous standard therapy and cannot be cured by any known standard of treatment may be eligible to participate in this clinical trial.
What is involved?
Patients may remain in the study and continue to receive drug as long as they are responding to therapy, or the cancer is not getting worse. Each cycle of treatment is 28 days long and consists of two doses of HGS-ETR2. HGS-ETR2 was made specifically to try to find and activate a receptor, called TRAIL receptor, that sits on the surface of some tumor cells. When TRAIL receptor is activated, it can cause the tumor cell to destroy itself. 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
- Pregnancy test (for women of childbearing age)
- Imaging tests (such as CT scan, MRI, bone scan, or MIBG) as 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
- Pregnancy test before each dose (for women of childbearing age)
- Imaging 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, HGS-ETR2. The potential benefit of the treatment with HGS-ETR2 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 HGS-ETR2 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, 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.
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
