Oncology (Medical)

Below are current clinical trials.

Filter this list of studies by location, status and more.

1. Tumor Molecular Analysis

   Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

   The purpose of this study is to develop preclinical models that include cell lines and patient derived xenografts (PDX) that include molecular characterization and testing novel therapies in these preclinical models. Molecular characterization may include short tandem DNA repeat; STR) and oncogenic/tumor suppressor gene mutation analyses to assure that the derived models have not been cross contaminated during the development process with other ongoing lines. Tissue microarray and immunohistochemical (IHC) analysis will also be performed on cell lines, PDX and patient tissues to identify potential molecular targets for therapy.

   For patients who consented, patient clinical therapy response data may be correlated with preclinical response data in cell lines and PDX models. 

2. A Study to Evaluate Screening Contrast Enhanced Digital Mammogram (CEDM) in Study Participants at Intermediate Breast Cancer Risk and Polygenic Risk Score (PRS) Results

   Rochester, Minn.

   The purpose of this study is to evaluate a low-cost Contrast Enhanced Digital Mammogram (CEDM) protocol as a supplemental screening method to standard mammographic screening in women at intermediate lifetime-risk (and not undergoing annual MR surveillance) for breast cancer.

    

    

    

    

3. A Study of the Ability to Predict Lymphedema Development Following Axillary Surgery for Breast Cancer and Its Effects on Patient Survivorship

   Jacksonville, Fla.

   The purpose of this study is to better understand the anatomy of the lymphatic structure and the molecular process that leads to the over production of lymph fluid.  This proposal will begin intense lymphedema screening and identify baseline characteristics potentially predisposing someone to lymphedema, and identify molecular markers that might be altered to prevent lymphedema. 

4. Benevolent Tumor Tissue Repository Fighting for the Legacy of our Young

   Rochester, Minn.

   The aim of this study is to create a patient and patient-advocate catalyzed tumor bank for the retrieval, processing, analysis, and maintenance of pre-treatment, post-treatment and (when available) post-mortem soft tissue sarcoma (STS) tissue and tissue data with an emphasis on STSs occurring in younger patients (YP-STS). This resource-platform will be named Project BTTRFLY (Benevolent Tumor Tissue Repository Fighting for the Legacy of our Young).  

5. Assessing the Psychosocial and Financial Impact of CAR-T on Survivors and Caregivers

   Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

   Although survivorship recommendations have been developed in areas such as lymphoma and stem cell transplant, the long-term effects of CAR-T therapy are unknown. In addition, relatively little is known about the psychosocial impact of CAR-T on survivors and their caregivers. Due to the intensive nature of CAR-T treatment and its unique side effects, including neurotoxicity in the acute setting and infections and financial burden in the long-term setting, a longitudinal study that assesses these issues in a quantitative and qualitative fashion is required. Consideration of both patient and caregiver needs is important for the provision of appropriate and effective health services, particularly in intensive cancer treatments that require a caregiver, such as CAR-T.

   Our objective in this proposal is to define the long-term needs of CAR-T survivors using patient-reported health-related quality of life (QOL) measures, qualitative interviews, and adverse event data. The rationale for our proposed study is that it will provide the necessary knowledge on CAR-T survivor physical, mental, and social health to formulate a CAR-T specific survivorship program that can be implemented and studied in the future.

   We aim to recruit 100 subjects (50 survivors and 50 caregivers) to the study. Inclusion Criteria are the following:  age ≥ 18, blood cancer diagnosis (including B-ALL, multiple myeloma, and lymphoma), receiving a CAR-T product, able to complete a written questionnaire in English either independently or with assistance, and able to perform a verbal interview either in person or via phone teleconference. We will survey patients at baseline and then at pre-specified timepoints up to 2 years after CAR-T. Survey questionnaires that have been previously validated in cancer populations will be used to assess: overall quality of life, psychosocial impact, cognitive function, post-traumatic stress, spiritual well-being, and financial toxicity. Patient demographics, adverse events, and comorbidities will also be collected via survey and/or medical record review. A selected subset of participants (10 survivors and 10 caregivers) will be chosen to undergo semi-structured open ended interviewing to obtain a qualitative understanding of unmet needs, social support, and distress. Data will be analyzed and compared to historical lymphoma and transplant cohorts.

6. Impact Of Surgical Removal Or Reduction Procedures On Markers Of Immune Function In Adult Patients With Renal And Bladder Tumors And Pediatric Patients With Genitourinary Tumors

   Rochester, Minn.

   The purpose of this study is to find out more about certain markers of immune suppression in people with kidney tumors (whether the tumors are benign or cancer). Also want to find out if kidney tumor treatment leads to an improvement in these immune markers.

7. A Study To Collect Clinical Data And Store Samples Of Blood And Tissue For Current And Future Research Studies On Sarcoma

   Jacksonville, Fla.

   This study is being done to collect clinical data and store samples of your blood and tissue for current and future research studies on sarcoma.

8. Olaparib, Cediranib Maleate, and Standard Chemotherapy in Treating Patients With Small Cell Lung Cancer

   Jacksonville, Fla.

   This randomized phase II trial studies how well olaparib, cediranib maleate, and standard chemotherapy work in treating patients with small cell lung cancer. Drugs used in chemotherapy, such as carboplatin, cisplatin, and etoposide, 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. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Olaparib, cediranib maleate, and standard chemotherapy may work better in treating patients with small cell lung cancer.

9. A Study to Evaluate the Incidence and Psychological Impact of Vaginal Cuff Dehiscence After Different Types of Hysterectomy

   Rochester, Minn.

   The purpose of this study is to compare the incidence of cuff dehiscence in patients who have undergone total robotic laparoscopic hysterectomy vs. total vaginal hysterectomy, to identify risk factors for cuff dehiscence, and to study the impact of cuff dehiscence on a patient’s psychological well-being.

10. Iobenguane I-131 Or Crizotinib And Standard Therapy In Treating Younger Patients With Newly-Diagnosed High-Risk Neuroblastoma Or Ganglioneuroblastoma

    Rochester, Minn.

    Despite recent improvements in outcome for children with newly diagnosed high-risk neuroblastoma, cure rates  remain  unsatisfactory.Further, these gains have been the result of interventions during the Consolidation (tandem autologous stem cell transplant) and Post-Consolidation (dinutuximab immunotherapy) phases of treatment, while rates of disease control during Induction have not improved in recent COG trials. The current phase 3 trial seeks to improve the event-free survival (EFS) for children with high-risk neuroblastoma through early integration of promising novel targeted therapies: targeted radiopharmaceutical therapy with 131I-MIBG or the ALK inhibitor, crizotinib. After enrollment, patients will receive one cycle of Induction chemotherapy. Subsequent therapy will be based upon MIBG avidity and ALK status. Patients with MIBG-avid, ALK wild type (or ALK unknown) disease will be randomized to one of three arms: A) current COG recommended high-risk therapy including four more cycles of Induction chemotherapy and surgical resection of the primary tumor, Consolidation with tandem transplant and focal external beam radiation, and dinutuximab immunotherapy with isotretinoin; B) current COG recommended high-risk therapy with the addition of a block of 131I-MIBG after the third Induction cycle; or C) current COG recommended high-risk therapy with the addition of a block of 131I-MIBG after the third Induction cycle and substitution of busulfan / melphalan (BuMel) single autologous stem cell transplant in place of tandem transplant. Patients with MIBG non-avid, ALK wild type (or ALK unknown) disease will be non-randomly assigned to receive current COG recommended high-risk therapy without the addition of 131I-MIBG. Patients with ALK aberrant tumors (ALK tyrosine kinase mutation or ALK amplification) will be non-randomly assigned to receive crizotinib added to current COG recommended high-risk therapy. The primary endpoint is EFS and 774 eligible and evaluable patients are anticipated to enroll over approximately 5 years. Key secondary endpoints are toxicity, end-Induction response, and overall survival. Late effects of therapy including targeted therapies will be compared with late effects of current COG recommended treatments Embedded correlative studies seek to understand predictors of benefit and resistance to 131I-MIBG and crizotinib.