ACNS0223: a pilot study using carboplatin, vincristine and temozolomide for children < 10 years with progressive OR symptomatic low-grade gliomas
Date Last Modified:
Date First Published: 2/27/2007
What is the purpose of this study?
The purpose of this research study is to find out whether the growth of low-grade gliomas can be stopped effectively with the following combination of anti-cancer drugs (chemotherapy): carboplatin, vincristine, and temozolomide. Researchers want to find out what effects (good and bad) this combination of drugs has on low-grade gliomas and on their body. They also want to determine whether this combination of drugs can be given without causing serious side-effects; that is, side effects that would cause patients to have to be hospitalized, would cause permanent injury, or disability, or death.
Who will be included in this study?
Patients with brain tumors called a glioma and who are ≤10 years old are eligible to participate in this clinical trial.
What is involved?
Patients may be in the study for about 18 months, as long as they are responding to therapy, or the cancer is not getting worse. However, patients will continue to have physical exams and blood tests 3 to 4 times a year for the first two years off therapy and then 1 to 2 times a year. Their doctor will continue to follow up about 10 years after the study closes.
Patients who can participate in this study will take part in standard treatment procedures and tests. These procedure and tests will include:
- Physical exams
- Blood tests
- Kidney function tests
- Liver function tests
- Neurological function and psychological tests
- Eye exams (to evaluate tumor involvement with the structures of the eye)
- MRI Evaluations (Magnetic Resonance Imaging (MRI) is a technique for taking pictures of the soft tissues of the body, including the brain)
- Magnetic Resonance (MR) Myelograms (is an X-ray exam of the spinal canal and nerves) and
- Other tests on the cerebrospinal fluid
The chemotherapy treatment on this study is given in two stages: Induction and Maintenance. In both Induction and Maintenance, all three anti-cancer drugs will be given (Vincristine, Carboplatin, and Temozolomide).
- Vincristine and carboplatin will both be given intravenously, IV (using a needle inserted into a vein)
- Temozolomide will be given orally (by mouth)
- Induction stage (last ten weeks to evaluate the drugs effect on the tumor and the stability of the disease)
- Maintenance stage (consists of six 10-week cycles of chemotherapy with the 3-drug combination)
Patients will rest during weeks 7, 8, and 9 of the Induction period when no chemotherapy is given.
At the end of each Maintenance cycle, patients will begin the maintenance treatment all over again until patients have completed 6 cycles
All chemotherapy on this study will be given on an outpatient basis unless side effects develop that require hospitalization. Therefore, appropriate general supportive care will be used as necessary.
What are the benefits?
Patients may receive no direct benefit from participating in this study. The potential benefit is that chemotherapy drugs (Vincristine, Carboplatin, and Temozolomide) may cause cancer to stop growing or go into partial remission for a period of time or it may lessen symptoms. The knowledge gained from this study may be helpful to other children with low-grade gliomas. Clinical trials are essential in finding new and improved treatments.
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 them and will be sure that all of their 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 / guardians 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: 513-636-2279
cancer@cchmc.org
