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  • A Phase II Study of Ipilimumab, Cabozantinib, and Nivolumab in Rare Genitourinary Cancers (ICONIC) (ICONIC) Rochester, Minn., Eau Claire, Wis., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to assess how well cabozantinib works in combination with nivolumab and ipilimumab in treating patients with rare genitourinary (GU) tumors that have spread to other places in the body. Cabozantinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cabozantinib, nivolumab, and ipilimumab may work better in treating patients with genitourinary tumors that have no treatment options compared to giving cabozantinib, nivolumab, or ipilimumab alone.

  • A Randomized Phase III Trial Comparing Active Symptom Monitoring Plus Patient Education Versus Patient Education Alone to Improve Persistence With Endocrine Therapy in Young Women With Stage I-III Breast Cancer (ASPEN) (ASPEN) La Crosse, Wis., Eau Claire, Wis., Albert Lea, Minn.

    The purpose of this study is to compare the effect of active symptom monitoring and patient education to patient education alone in helping young women with stage I-III breast cancer stay on their hormone therapy medicines.  

  • A082002 A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy With or Without SBRT for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer La Crosse, Wis., Scottsdale/Phoenix, Ariz.

    The purpose of this phase II/III trial is to compare the addition of radiation therapy to the usual treatment (immunotherapy with or without chemotherapy) vs. usual treatment alone in treating patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (advanced) or has spread to other places in the body (metastatic) whose tumor is also negative for a molecular marker called PD-L1. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that uses high energy x-rays to kill tumor cells and shrink tumors. This method uses special equipment to position a patient and precisely deliver radiation to tumors with fewer doses over a shorter period and may cause less damage to normal tissue than conventional radiation therapy. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab and pembrolizumab, 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 carboplatin, pemetrexed, paclitaxel and nab-paclitaxel, 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. The addition of radiation therapy to usual treatment may stop the cancer from growing and increase the life of patients with advanced non-small cell lung cancer who are PD-L1 negative.

  • AL-DES-01; RINGSIDE: A Phase 2/3, Randomized, Multicenter Study to Evaluate AL102 in Patients With Progressing Desmoid Tumors (RINGSIDE) Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to evaluate the effectiveness and safety of AL102 in patients with progressive desmoid tumors.

  • Blinded Reference Set for Multicancer Early Detection Blood Tests Mankato, Minn., La Crosse, Wis., Eau Claire, Wis., Albert Lea, Minn.

    The purpose of this study is to collect blood and tissue samples from patients with and without cancer to evaluate laboratory tests for early cancer detection which may help researchers develop tests for the early detection of cancers.

  • Detecting Cancers Earlier Through Elective Plasma-based CancerSEEK Testing – Ascertaining Serial Cancer Patients to Enable New Diagnostic II (DETECT-ASCEND 2) (ASCEND 2) Rochester, Minn., Mankato, Minn., La Crosse, Wis., Eau Claire, Wis., Scottsdale/Phoenix, Ariz., Albert Lea, Minn.

    The purpose of this study is to obtain clinically characterized, whole blood specimens from participants with new or suspected diagnosis of (cancer subjects) and from participants who do not have a diagnosis of cancer (healthy subjects) to develop and refine assays for cancer in the blood

    The primary objective of this study is to obtain clinically characterized, whole blood specimens from cancer and healthy subjects to develop and refine assays for cancer in the blood.

     

  • EA1181, (CompassHER2-pCR): Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response (CompassHER2-pCR) Rochester, Minn., La Crosse, Wis., Eau Claire, Wis. This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, 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. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.
  • EAA181, Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended For Early Autologous Transplantation (EQUATE) Rochester, Minn., La Crosse, Wis.

    The primary purpose of this study is to determine if bortezomib, daratumumab, lenalidomide and dexamethasone (Btz-DRd) consolidation followed by daratumumab and lenalidomide (DR) maintenance after standard induction therapy with daratumumab, lenalidomide and dexamethasone (DRd) results in superior overall survival compared to DRd consolidation followed by DR maintenance, in MRD positive patients.

  • LS1781, Phase 2 Trial of High Dose Intravenous Ascorbic Acid as an Adjunct to Salvage Chemotherapy in Relapsed / Refractory Lymphoma and Patients with Clonal Cytopenia of Undetermined Significance Rochester, Minn., La Crosse, Wis.

    The purpose of this study is to examine how well ascorbic acid and combination chemotherapy work in treating patients with lymphoma that has come back or does not respond to therapy. Ascorbic acid may make cancer cells more sensitive to chemotherapy. Drugs used in chemotherapy, 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. Giving ascorbic acid and combination chemotherapy may work better at treating lymphoma.

    In the Clonal Cytopenia of Undetermined Significance (CCUS) Cohort D, we want to find out if ascorbic acid will improve blood counts so fewer transfusions  are required and there is a less likely chance the patient will develop myelodysplastic syndrome (MDS) or other related myeloid malignancies.

  • Megakaryocytes and Platelets, Harmful or Helpful in Breast Cancer Cell Metastasis (Megakaryocytes) La Crosse, Wis.

    The purpose of this study is to determine how megakarocytes (cells in the bone marrow responsible for making platelets, which are necessary for blood clotting) affect the survivial and growth/division patterns of breast cancer stem cells, and the effects of breast cancer cells on megakatocyte survival and function. Through chart review, the study team will look at the relationship different blood components and different breast cancer diagnosis.

  • NHLBI-MDS, The National Myelodysplastic Syndromes Natural History Study (MDS) La Crosse, Wis., Jacksonville, Fla.

    Multi-center study enrolling patients suspected or newly diagnosed with myelodysplastic syndromes (MDS), myelodysplastic syndromes/myeloproliferative neoplasms (MDS/MPN) overlap disorder, or idiopathic cytopenia of undetermined significance (ICUS). Participants will be followed long term. Clinical data, blood, and tissue samples will be collected to establish a biorepository to facilitate the study of the natural history of MDS.

  • PH-L19TNFDOX2-02/17: A randomized study comparing the efficacy of the combination of doxorubicin and the tumor-targeting human antibody-cytokine fusion protein L19TNF to doxorubicin alone as first-line therapy in patients with metastatic leiomyosarcoma (FIBROSARC USA) Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

    The present study is an open-label, randomized, controlled, two-arm multi-center study of the efficacy of L19TNF treatment in combination with doxorubicin versus doxorubicin alone in metastatic or unresectable soft-tissue sarcoma patients. In the study, 122 patients will be randomized in a 1:1 ratio to receive doxorubicin treatment (Arm 1) or L19TNF treatment in combination with doxorubicin (Arm 2). The primary objective of the trial is to evaluate if L19TNF in combination with doxorubicin (Arm 2) given for unresectable or metastatic soft tissue sarcoma improves efficacy measured as progression free survival, as compared to doxorubicin alone (Arm 1). Anti-cancer activity will be assessed every 6 weeks during therapy and every 12 weeks thereafter.

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  • A082002 A Randomized Phase II/III Trial of Modern Immunotherapy Based Systemic Therapy With or Without SBRT for PD-L1-Negative, Advanced Non-Small Cell Lung Cancer Jacksonville, Fla., Rochester, Minn.

    The purpose of this phase II/III trial is to compare the addition of radiation therapy to the usual treatment (immunotherapy with or without chemotherapy) vs. usual treatment alone in treating patients with non-small cell lung cancer that has spread to nearby tissue or lymph nodes (advanced) or has spread to other places in the body (metastatic) whose tumor is also negative for a molecular marker called PD-L1. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that uses high energy x-rays to kill tumor cells and shrink tumors. This method uses special equipment to position a patient and precisely deliver radiation to tumors with fewer doses over a shorter period and may cause less damage to normal tissue than conventional radiation therapy. Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab and pembrolizumab, 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 carboplatin, pemetrexed, paclitaxel and nab-paclitaxel, 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. The addition of radiation therapy to usual treatment may stop the cancer from growing and increase the life of patients with advanced non-small cell lung cancer who are PD-L1 negative.

  • LS1781, Phase 2 Trial of High Dose Intravenous Ascorbic Acid as an Adjunct to Salvage Chemotherapy in Relapsed / Refractory Lymphoma and Patients with Clonal Cytopenia of Undetermined Significance Mankato, Minn., Eau Claire, Wis.

    The purpose of this study is to examine how well ascorbic acid and combination chemotherapy work in treating patients with lymphoma that has come back or does not respond to therapy. Ascorbic acid may make cancer cells more sensitive to chemotherapy. Drugs used in chemotherapy, 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. Giving ascorbic acid and combination chemotherapy may work better at treating lymphoma.

    In the Clonal Cytopenia of Undetermined Significance (CCUS) Cohort D, we want to find out if ascorbic acid will improve blood counts so fewer transfusions  are required and there is a less likely chance the patient will develop myelodysplastic syndrome (MDS) or other related myeloid malignancies.

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