A Phase II Pilot Trial of Bortezomib (PS-341, Velcade®, IND# 58,443) in Combination with Intensive Re-Induction Therapy for Children with Relapsed Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL)
The aims of this study are to improve study treatment for relapsed ALL. However, LL has been shown to respond to chemotherapy in a similar way to ALL and is often treated as a leukemia. Therefore, we think that the therapy may also have an effect on LL.
This study is a Phase 2 study. A phase 2 study is done to measure the response of a disease to an experimental drug. This study is being done to find out if adding bortezomib to the standard Re-Induction therapy is a helpful and effective therapy for treating children and young adults with relapsed ALL.
The goals of this study are:
This study is organized by Children’s Oncology Group (COG).
Approximately 6 subjects will participate at the University of Iowa. The maximum number of people enrolled on this study is expected to be around 151. This total includes both leukemia and lymphoma subjects.
Julie de la Garza, RN (319) 356-3749 or email@example.com
Participants in this research study have a favorable histology Wilms tumor that has some risk of returning after treatment. The purpose of this research study is to find out if subjects with a higher risk of having their tumor return will benefit from the addition of doxorubicin or the current standard treatment. Approximately 5 people will take part in this study at the University of Iowa. Study involvement will last for 25 weeks and will have follow-up examinations and tests for about 5 years.
Julie de la Garza, 319-356-3749
Participants in this research study have been diagnosed with an osteosarcoma. Osteosarcoma is a type of cancer that occurs in the bones. Study doctors want to find better ways to detect and prevent osteosarcoma. To do this, they need samples of osteosarcoma tumors and some blood from people with these tumors. The goal of this study is to collect osteosarcoma tumor specimens and blood samples from patients with these tumors. These specimens will be used by researchers to increase our knowledge about how to diagnose and treat osteosarcoma.
Individuals often develop serious infections when their granulocyte counts are very low. The purpose of this research study is to determine the effects of granulocyte transfusion therapy (both helpful and harmful) in the treatment of individuals who have serious infections and low granulocyte (infection fighting cells) counts as a result of chemotherapy or stem cell transplantation. Two treatment groups will be used in this study. The first group will receive standard antibiotic therapy (medications that are used to fight infections). The second group will receive standard antibiotic therapy plus granulocyte transfusions (white blood cells or infection fighting cells).
Ronald Strauss, 319-384-4551
Intensified Methotrexate, Nelarabine (Compound 506U78; IND # 52611) and Augmented BFM Therapy for Children and Young Adults with Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic Lymphoma
ALL is a type of cancer that occurs in the bone marrow. ALL is divided into groups based on the cell type (B-cell or T-cell) and how the cells appear under the microscope. It is a disease in which there is an uncontrolled growth of abnormal white blood cells, referred to as blasts. These abnormal cells crowd out the normal cells in the bone marrow. Sometimes these blasts cells can be found in the brain, spinal cord, and /or other organs of the body.
The overall goal of this study is to see if we can get rid of the cancer for as long as possible with acceptable side effects of therapy. Side effects are unintended and unwanted results of treatment.
The total number of people with T-ALL enrolled on this study is expected to be 1461 world-wide. Approximately 12 people will take part of this study at the University of Iowa.
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