Trial Information

Summary: A Phase II Study of Rituximab and Ifosfamide, Carboplatin and Etoposide (ICE) Chemotherapy In Children with Recurrent/Refractory B-cell (CD20+) Non-Hodgkin Lymphoma and B-cell Acute Lymphoblastic Leukemia

What is the purpose of this study?
The goals of this research study are:

• to determine if an investigational drug, Rituximab, in combination with the commonly used cancer drugs ifosfamide, carboplatin, and etoposide, is successful in treating refractory or recurrent non-Hodgkin lymphoma (NHL)
• to find out what the effects, good and bad, are for this drug combination
• to find out if it is possible to examine tumor and other specimens and to determine if there are any cancer cells left after treatment is finished
• to study the genes that are found in the patient's type of NHL or B-ALL (B-cell acute lymphoblastic leukemia) and to see if the genes can predict how patients with this type of NHL or B-ALL will respond to treatment on this protocol
• to find out if the combination of drugs given in this study will make it easier to collect enough stem cells (primitive cells in the blood that can develop into specialized types of cells) so that patients may undergo stem cell transplantation, if this becomes necessary in future treatment.

Who will be included in this study?
Patients with recurrent/refractory B-cell (CD20+) non-hodgkin lymphoma and B-cell acute lymphoblastic leukemia who are less than 21 years of age may be eligible to participate in this clinical trial.

What is involved?
Patients will be treated on this study for up to three months. However, patients will continue to have physical exams and blood tests for a few years after treatment so that researchers can continue to observe any effects of treatment.

Before treatment on this study begins, and while receiving treatment, patients will receive several standard medical tests:

• Physical exam
• Medical history
• Blood tests
• Urinalysis
• Imaging tests (CT scans, MRIs)
• Bone marrow analysis
• Spinal taps
• Other optional laboratory studies

What are the benefits?
Patients, who agree to take part in this research study, may or may not experience direct medical benefits. It is hoped that the information learned from this study may help future patients with refractory or recurrent non-Hodgkin’s lymphoma.

Will I get all the facts about the study?
Parents interested in having their child participate and adult patients 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 patient 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 the adult patient 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.

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