ADVL0515: A Phase I Study of Vinblastine in Combination with Carboplatin for Children with Newly Diagnosed and Recurrent Low-Grade Gliomas
Date Last Modified:
Date First Published: 11/27/2006
What is the purpose of this study?
The goals of this research study are:
- To find the highest safe dose of vinblastine that can be given in combination with carboplatin without causing severe side effects
- To learn what kind of side effects the combination of vinblastine and carboplatin can cause
- To learn more about what kind of changes can be seen in the tumor on MRI scans after giving the combination of vinblastine and carboplatin
- To determine whether the combination of vinblastine and carboplatin is a beneficial treatment for the patient's tumor
Who will be included in this study?
Patients with low-grade gliomas and who are ≤ 21 years old are eligible to participate in this clinical trial.
What is involved?
Patients receive carboplatin and vincristine treatment every 6 weeks. Patients may be in the study for a little over 12 months if the patient's tumor does not grow.
Before the Study Begins
Patients will need to have the following exams, tests, or procedures to find out if the patient 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 test have been performed recently, they may not need to be repeated. This will be up to the study doctor.
- A medical history and vital signs (blood pressure, pluse, and temperature)
- Physical exam
- Blood tests
- Pregnancy test for females of childbearing age
- MRI Scans (a MRI uses magnetic waves to make pictures of the brain, so we can see the tumor)
During the Study
Patients will also be given the following tests and procedures during the study. These test and procedures are part of regular low-grade glioma care:
- Physical exam
- Blood tests
- MRI scans
- Eye exams if you have a tumor involving the visual pathway
What are the benefits?
There may be no direct benefit for participants who agree to take part in this research study. The potential benefit of the treatment with vinblastine in combination with carboplatin is that it may cause the patient's tumor to stop growing or to shrink for a period of time. It may lessen the symptoms that are caused by this tumor. Because there is not much information about the effect of vinblastine when given together with carboplatin, we do not know if the patient will benefit from taking part in this study. Information learned from this study may help future patients with cancer. The disease may continue to become worse despite taking these cancer drugs.
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 the patient and will be sure that all of the patient's questions are answered. 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 can 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: 513-636-0215
cancer@cchmc.org
