Introduction

Before agreeing that you/your child will take part in this research, it is important that you read and understand the following explanation. It tells about the purpose, the plan, any possible benefits, the risks and discomforts, and the safeguards that will be taken. It also describes other options available. You will be told about possible side effects, about any treatment that is part of the research, and any parts of the research which are experimental procedures.

It is important that you understand several general principles that apply to all who take part in research studies:

1. Taking part in the research is entirely voluntary. You/your child can decide to take part or not.
2. You/your child are free to withdraw from the research at any time without affecting other parts of your/your child's care.
3. If you decide to not take part or to withdraw, you/your child can still be treated at this clinic and will still be offered the best care for the patient's needs.
4. Personal benefit may not result from taking part in the research, but knowledge may be gained that will benefit others.
5. You/your child are encouraged to ask questions about this research at any time.

If you sign this consent form, you agree to take part in this research

Background

You/Your child have been diagnosed with a malignant brain tumor. A malignant brain tumor is a cancer of the brain cells. You are invited to take part in a research about this condition.

This research is part of nation-wide study coordinated by the Childrens Cancer Group (CCG). CCG is a group of doctors, nurses, and other cancer specialists from more than 90 institutions in the United States and Canada. The purpose of this group is to study childhood cancer and improve its treatment. It allows all children treated at any CCG member institution to receive the treatment CCG believes to be the best available. Members of CCG meet twice a year to evaluate results of treatment and to plan news treatments. When institutions work together, advances in therapies can be made more rapidly than if each works alone. The goal of CCG is to improve the survival and cure rates of children with cancer.

Malignant brain tumors diagnosed in infants and young children are usually associated with poor outcome. Standard treatment for brain tumors in very young children usually consist of surgery (in most cases) followed by radiation therapy and/or chemotherapy. Although brain tumors initially respond well to this standard treatment approach, brain tumors have a high risk of coming back (relapsing) and radiation can contribute to significant side effects. In an attempt to delay or avoid exposure to radiation therapy, recent studies have shown that treating children with high dose chemotherapy after surgery may improve outcome. However, high dose chemotherapy can also contribute to significant side effects.

We propose to test some changes to standard treatment to see if these changes can improve prognosis. One of the changes is to treat children with a standard chemotherapy drug regimen followed by a new chemotherapy drug regimen that uses Thiotepa and Carboplatin. In this study, we want to find Thiotepa doses high enough to have activity against your child's tumor, without causing too much harm. To test the safety of Thiotepa when it is given with Carboplatin, different dose levels will be tested. Each dose level will be tested in groups of 6 patients. The dose will be increased until the side effects are unacceptable. If the starting dose causes unacceptable side effects, then the doses tested will be decreased.

Another purpose of this study is to find out if the harmful effects from chemotherapy can be reduced by using a new method to help the body create new healthy blood cells following high dose chemotherapy. This new method is called peripheral blood stem cell (PBSC) support. Other clinical studies in adults have shown that PBSC support following chemotherapy may reduce the amount of time it takes for the body to recover from intensive chemotherapy drugs.

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