A Phase II Study to Assess the Ability of Neoadjuvant Chemotherapy +/- Second Look Surgery to Eliminate All Measurable Disease Prior to Radiotherapy for Non-Germinomatous Germ Cell Tumor (NGGCT)
What is the purpose of this study?
- To see how well patients with non-germinomatous germ cell tumor (NGGCT) respond to the anti-cancer drugs (chemotherapy) used in the first part of this study called Induction. These drugs are carboplatin, etoposide (VP-16), and ifosfamide.
- To see if high-dose anti-cancer drugs (thiotepa plus VP-16) with peripheral blood stem cell (PBSC) rescue work better at getting rid of the cancer in patients who did not respond well enough to the standard-dose chemotherapy given in Induction.
- To determine the survival rates of patients with NGGCT who get the therapy offered by this study.
- To determine the frequency of certain toxicities, i.e., side effects that occur as a result of the treatment. Side effects are unintended physical reactions that are unrelated to the reason the treatment is being given. The side effects that researchers think might occur on this study are described later in this consent document.
- To monitor how tumor markers in blood and spinal fluid correspond with results from scans, exams, or surgery in response to the chemotherapy treatment.
Who will be included in this study?
Patients between 3 years old and 24 years old who have been diagnosed with a type of brain cancer called non-germinomatous germ cell tumor may be eligible to participate in this clinical trial. This is a brain tumor formed by cancerous cells. Germ cells are very primitive cells.
What is involved?
Patients will be treated on this study for about eight months. However, patients will continue to have physical exams, blood tests, and MRI scans of the brain and spine for three years after treatment so that researchers can continue to observe any effects of treatment. After three years, patients will continue to have a physical exam, MRI scan of the brain and spine, and blood tests every year.
Before treatment on this study begins, and while receiving treatment, patients will be given a series of standard medical tests:
- Physical exam
- Blood tests
- Urine tests
- Tests of liver function
- Pregnancy test (before the start of treatment for females of childbearing potential)
- Magnetic Resonance Imaging (MRI) of brain and spine. (MRI uses magnetic waves to look at soft tissues of the body)
- Spinal tap
- Eye exam
What are the benefits?
Participants who agree to take part in this research study, may or may not experience direct medical benefits although this study is aimed at improving survival rates of patients with NGGCT. The information learned from this research study may benefit other patients with non-germinomatous germ cell tumors.
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 scheduled with a physician who will thoroughly explain all of the details of the study. Your physician will review the consent form with you and will be sure that all of your questions are answered. The consent form goes over all of the procedures, the risks, the benefits, the compensation, who to contact with questions or concerns and more. Study procedures will not begin until a patient/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 will 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
