Clinical Trials

This phase II trial studies the best approach to combine chemotherapy and radiation therapy (RT) based on the patient's response to induction chemotherapy in patients with non-germinomatous germ cell tumors (NGGCT) that have not spread to other parts of the brain or body (localized). This study has 2 goals: 1) optimizing radiation for patients who respond well to induction chemotherapy to diminish spinal cord relapses, 2) utilizing higher dose chemotherapy followed by conventional RT in patients who did not respond to induction chemotherapy. Chemotherapy drugs, such as carboplatin, etoposide, ifosfamide, and thiotepa, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays or high-energy protons to kill tumor cells and shrink tumors. Studies have shown that patients with newly-diagnosed localized NGGCT, whose disease responds well to chemotherapy before receiving radiation therapy, are more likely to be free of the disease for a longer time than are patients for whom the chemotherapy does not efficiently eliminate or reduce the size of the tumor. The purpose of this study is to see how well the tumors respond to induction chemotherapy to decide what treatment to give next. Some patients will be given RT to the spine and a portion of the brain. Others will be given high dose chemotherapy and a stem cell transplant before RT to the whole brain and spine. Giving treatment based on the response to induction chemotherapy may lower the side effects of radiation in some patients and adjust the therapy to a more efficient one for other patients with localized NGGCT.

Welter, Stacy L

welter.stacy@marshfieldresearch.org

(715) 221-6492

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI  54449

This phase III trial tests the addition of sodium thiosulfate to standard of care chemotherapy and radiation therapy in treating patients with low or average risk medulloblastoma (a type of cancer in the brain). Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Although treatment for newly diagnosed average-risk and low-risk medulloblastoma is generally effective at treating the cancer, there are still concerns about the side effects of such treatment. Side effects are unintended problems that arise due to treatment such as learning difficulties, lower amounts of hormones, hearing problems, or other problems in performing daily activities. Patients with medulloblastoma often receive treatment with chemotherapy drugs including cisplatin. Cisplatin may cause hearing loss as a side effect. Previous studies with sodium thiosulfate have shown that it may help reduce or prevent hearing loss caused by cisplatin. This study looks at adding sodium thiosulfate to standard treatment for medulloblastoma (radiation therapy and chemotherapy, including cisplatin) to find out if it reduces hearing loss.

Welter, Stacy L

welter.stacy@marshfieldresearch.org

(715) 221-6492

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI  54449

This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment (chemotherapy with or without radiation) alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival in patients with classical Hodgkin lymphoma compared to the standard treatment alone.

Wolf, Terri L

wolf.terri@marshfieldclinic.org

(715) 387-9316

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI  54449

Neuropsychological and behavioral assessments are a crucial component of monitoring for late effects in patients being treated, normally quite aggressively, for cancer. This is especially true for patients that are exposed to potentially neurotoxic therapies. However, lack of compliance with assessment schedules, variations in assessment schedules and neuropsychological measures utilized across studies, as well as overly complex and long neuropsychological assessments have proved to be problematic to the assessment process within the Children's Oncology Group (COG). In order to remediate these problems, a streamlined and standardized neuropsychological and behavioral assessment battery has been developed. The COG Standard Neuropsychological and Behavioral Battery is a focused assessment of critical functional domains that have been empirically shown to be most affected by childhood cancer, its treatment, or other disease related factors. This battery was designed to provide a brief measure of neuropsychological and behavioral function in order to strike a balance between research goals, the clinical needs of the patient, and time constraints on the institutional neuropsychologist/psychologist. The battery of tests will take only about 1 hour to administer and all patients will be tested at 3 standardized timepoints. Parent-completed questionnaires will also be utilized to gather information about the patient's function, specifically in terms of attention, memory, executive abilities, and behavioral/social/emotional adaptation.

Welter, Stacy L

welter.stacy@marshfieldresearch.org

(715) 221-6492

Marshfield Medical Center

611 Saint Joseph Ave

Marshfield, WI  54449

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI  54449

This study attempts to learn more about the health of persons with Down syndrome after treatment for acute leukemia. Children with Down syndrome are at increased risk for side effects during treatment for acute leukemia, but it is unclear of their risk for long-term effects of cancer treatment. By learning more about the factors that may contribute to chronic health conditions and long-term effects after treatment for leukemia in persons with Down syndrome, clinical practice guidelines for survivorship care can be developed to help improve their quality-of-life.

Welter, Stacy L

welter.stacy@marshfieldresearch.org

(715) 221-6492

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI  54449

The objectives of the study are to prospectively analyze the factors that are currently used for risk-group assignment (NDA content by flow cytometry, MYCN copy number by FISH, and tumor histology using the International Neuroblastoma Pathologic Classification System) in neuroblastoma tumors at the time of diagnosis. To maintain a reference bank containing clinical and genetically characterized frozen tumor tissue, tumor DNA and RNA, tumor touch perpetration, histology slides and blocks, cell lines, and paired normal DNA obtained at the time of diagnosis (all patients), at the time of second-look surgery (high-risk patients), and relapse (all patients) for future research studies. To prospectively analyze the prevalence of 1p, 11q, 14q LOH and gain of 17q; the expression of nerve growth factor (NGF) and its high affinity (Trk-A) and low affinity (p75NTR) receptors; and telomerase activity in diagnostic neuroblastoma tumors, and to determine the independent clinical significance of these biologic factors compared to MYCN amplification, INSS stage, age, and histologic variables in predicting either response to treatment or outcome. To build a database of the known biologic prognostic factors for patients on therapeutic studies. Adjustment for, or stratification by, these prognostic factors will be performed when testing for treatment effect in Phase III trials.

Welter, Stacy L

welter.stacy@marshfieldresearch.org

(715) 221-6492

Marshfield Medical Center

611 Saint Joseph Ave

Marshfield, WI  54449

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI  54449

This phase III trial studies how well response and biology-based risk factor-guided therapy works in treating younger patients with non-high risk neuroblastoma. Sometimes a tumor may not need treatment until it progresses. In this case, observation may be sufficient. Measuring biomarkers in tumor cells may help plan when effective treatment is necessary and what the best treatment is. Response and biology-based risk factor-guided therapy may be effective in treating patients with non-high risk neuroblastoma and may help to avoid some of the risks and side effects related to standard treatment.

Welter, Stacy L

welter.stacy@marshfieldresearch.org

(715) 221-6492

Marshfield Medical Center

611 Saint Joseph Ave

Marshfield, WI  54449

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI  54449

This phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.

Welter, Stacy L

welter.stacy@marshfieldresearch.org

(715) 221-6492

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI  54449

This research trial studies the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

Welter, Stacy L

welter.stacy@marshfieldresearch.org

(715) 221-6492

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI  54449

This phase II trial studies Trk inhibitor LOXO-101 in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with NTRK fusions that have spread to other places in the body and have come back or do not respond to treatment. Trk inhibitor LOXO-101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.