Clinical Trials

This trial collects research data and samples from patients who experience immunotherapy side effects to store for use in future research studies. Studying research data and samples from patients who experience immunotherapy side effects may help researchers better understand how to predict, prevent, and treat these side effects.

Humphrey, Logan J

humphrey.logan@marshfieldresearch.org

Diagnostic & Treatment Center

3401 CRANBERRY BLVD

WESTON, WI  54476

Marshfield Medical Center - Rice Lake

1700 W STOUT ST

RICE LAKE, WI  54868

MC - Chippewa Falls Center

2655 CTY HWY I

CHIPPEWA FALLS, WI  54729

MC - Wausau Center

2727 PLAZA DRIVE

WAUSAU, WI  54401

MC - Wisconsin Rapids Center

220 24TH ST SOUTH

WISCONSIN RAPIDS, WI  54494

MMC - Eau Claire

2116 Craig Rd

Eau Claire, WI  54701

MMC - Eau Claire Cancer Center

2200 Craig Road

Eau Claire, WI  54701

MMC - Ladysmith

906 College Ave W

Ladysmith, WI  54848

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI  54449

MMC - Minocqua

9601 TOWNLINE RD

MINOCQUA, WI  54548

MMC - River Region at Stevens Point

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MMC - Weston

3501 CRANBERRY BLVD

WESTON, WI  54476

This phase III trial studies how well blinatumomab works in combination with chemotherapy in treating patients with or without Down syndrome and newly diagnosed, standard risk B-lymphoblastic leukemia or B-lymphoblastic lymphoma. Monoclonal antibodies, such as blinatumomab, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as vincristine, dexamethasone, prednisone, prednisolone, pegaspargase, methotrexate, cytarabine, mercaptopurine, doxorubicin, cyclophosphamide, and thioguanine, 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. Leucovorin decreases the toxic effects of methotrexate. Giving monoclonal antibody therapy with chemotherapy may kill more cancer cells. Giving blinatumomab and combination chemotherapy may work better then combination chemotherapy alone in treating patients with B-ALL. This trial also assigns patients into different chemotherapy treatment regimens based on risk (the chance of cancer returning after treatment). Treating patients with chemotherapy based on risk may help doctors decide which patients can best benefit from which chemotherapy treatment regimens.

Welter, Stacy L

welter.stacy@marshfieldresearch.org

(715) 221-6492

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI  54449

This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase 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. This trial will also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, in order to classify patients into post-consolidation treatment groups. On the second part of this study, patients will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.

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 levocarnitine to chemotherapy versus chemotherapy alone in protecting the liver in patients with leukemia and lymphoma. Standard of care chemotherapy treatment for leukemia and lymphoma includes a type of chemotherapy named asparaginase, given either as the drug pegaspargase, or a similar drug, calaspargase pegol. This type of chemotherapy can cause severe liver damage. Levocarnitine is a drug used to provide extra carnitine, a naturally occurring nutrient that is part of a typical diet and is also made by the body. Carnitine is important to keep the liver healthy and may be able to prevent damage to the liver from chemotherapy and other drugs. Taking levocarnitine may reduce the rate of severe liver damage caused by asparaginase chemotherapy in patients with leukemia and lymphoma.

Welter, Stacy L

welter.stacy@marshfieldresearch.org

(715) 221-6492

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI  54449

This study evaluates immunologic response following COVID-19 vaccination in children, adolescents, and young adults with cancer. Vaccines work by stimulating the body's immune cells to respond against a specific disease. The immune response produces protection from that disease. Effects from cancer and from treatments for cancer can reduce the body's natural disease fighting ability (called immunity). Factors such as vaccine type, timing of vaccine dosing related to treatment for cancer and number of vaccine doses or boosts (extra vaccine shots) may strengthen or diminish the body's protective immune response. This study may help researchers learn more about how the body's immune system responds to the COVID-19 vaccine when the vaccination is given during or after cancer treatment.

Welter, Stacy L

welter.stacy@marshfieldresearch.org

(715) 221-6492

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI  54449

This phase II trial studies how well the combination of dabrafenib and trametinib works after radiation therapy in children and young adults with high grade glioma who have a genetic change called BRAF V600 mutation. Radiation therapy uses high energy rays to kill tumor cells and reduce the size of tumors. Dabrafenib and trametinib may stop the growth of tumor cells by blocking BRAF and MEK, respectively, which are enzymes that tumor cells need for their growth. Giving dabrafenib with trametinib after radiation therapy may work better than treatments used in the past in patients with newly-diagnosed BRAF V600-mutant high-grade glioma.

Welter, Stacy L

welter.stacy@marshfieldresearch.org

(715) 221-6492

MMC - Marshfield

1000 N OAK AVE

MARSHFIELD, WI  54449

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 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