Trial Information

Summary: A Phase Study of Temozolomide, Oral Irinotecan, and Vincristine for Children with Refractory Solid Tumors

What is the purpose of this study?
We are testing new experimental drugs and experimental drug combinations such as irinotecan, temozolomide, and vincristine in the hopes of finding a drug that may be effective against recurrent tumors (tumors that come back).

This is a phase I study of a combination of three drugs: temozolomide, irinotecan, and vincristine. This is called a Phase I study because the goal is to find the highest dose of irinotecan that we can give safely in combination with temozolomide and vincristine. A safe dose is one that does not result in bad side effects. Once the highest dose of irinotecan that can be given safely with temozolomide and vincristine is found, a Phase II study may be done to find out if the combination is a beneficial treatment for cancer.

The combination of drugs in this study is considered experimental because the combination has not been approved by the Food and Drug Administration (FDA). All of the drugs used in this study have been approved by the FDA for use in adults with certain cancer types. Each drug has been given by itself to children before, and the combination of temozolomide and irinotecan has been given to children in another clinical trial. This is the first study in which all three of the drugs will be given to children together. We are using these drugs because they seem to work together against cancer in test tubes and animals. We do not know if the combination of temozolomide, irinotecan, and vincristine will work in people. There is a lot we do not know about the drug combination.

The goals of this study are:

• To find the highest safe dose of irinotecan that can be given in combination with temozolomide and vincristine, without causing severe side effects;
• To learn what kind of side effects the combination of temozolomide, irinotecan, and vincristine can cause;
• To learn more about the pharmacology of (how your body handles the drug) temozolomide, irinotecan, and vincristine;
• To find out if there is a genetic basis for how you respond to this treatment in tests called pharmacogenetics, or biology studies;
• To determine whether the combination of temozolomide, irinotecan, and vincristine is a beneficial treatment for your tumor.

Patients who are 1 to 21 years old at study entry who have a recurrent or progressive tumor (tumor that gets worse over time) that cannot be cured by any known standard treatment may be eligible to participate in this clinical trial.

What is involved?
Patients may be in the study for up to 12 months if they are responding to therapy. After patients are finished taking temozolomide, irinotecan, and vincristine, the study doctor will ask them to visit the office for follow-up exams. We would like to keep track of the patient’s medical condition for the rest of the patient’s life. We would like to do this by calling patients on the telephone once a year to see how they are doing. Keeping in touch with patients and checking on their condition every year helps us look at the long-term effects of the study.

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 they do not join the study. If patients have had some of them recently, they may not need to be repeated. This will be up to the study doctor.

• Medical history
• Physical exam
• Vital signs (blood pressure, pulse, temperature)
• Blood tests
• Urine test
• Pregnancy test (for females who could have children)

We will also do whatever X-rays, CT scans, or other tests are 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
• Tests to evaluate the tumor (the doctor will decide which test will be used)
• Optional research studies

Participants who agree to take part in this research study may experience no direct benefit. It is unlikely that participants will experience significant benefit or cure from these drugs vincristine, irinotecan and temozolomide. The potential benefit of the treatment with the combination of vincristine, irinotecan, and temozolomide 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 vincristine, irinotecan, and temozolomide in humans, we do not know if participants 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, the compensation, 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.

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?

If you would like to learn more about participating in this study, please send an e-mail message using the form below.