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Researchers are evaluating the effects of cannabis and cannabinoid use on cancer-related symptoms in adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer. This study focuses on patients who are planning to receive or have recently started systemic cancer treatments such as chemotherapy and immune checkpoint inhibitors (ICIs) targeting PD-1, PD-L1, or CTLA-4. The goal is to understand how cannabis use may be associated with symptom changes over time. Participants are enrolled in a non-interventional study where no experimental treatment is given. They complete surveys about their symptoms and cannabis use, and their medical records are reviewed regularly. The study tracks cancer-related symptoms monthly for up to 12 months after enrollment, allowing researchers to observe symptom patterns during ongoing cancer treatment. An optional substudy is available at select sites for patients with non-small cell lung cancer receiving paclitaxel and ICIs. During the study, participants complete online surveys in English or Spanish at their convenience, either at home or in clinic. Medical records are examined to gather information on treatments and health status. The main outcome measured is cancer-related symptoms, assessed monthly for one year. Safety monitoring includes ensuring participants have an expected life expectancy of at least six months and are not enrolled in hospice. The study aims to enroll 2000 patients across multiple sites in the United States.

Researchers are evaluating how factors like age, gender, other medical conditions, and the type of immunotherapy affect the development of side effects in patients with malignant solid tumors receiving immune checkpoint inhibitor (ICI) therapy. The study aims to develop and validate a risk prediction model for serious immune-related side effects during the first year of ICI treatment. Additional goals include tracking the occurrence of various side effects, quality of life, patient-reported symptoms, and treatment patterns over 12 months, along with studying biological markers that may predict side effect risk. Participants will have tissue samples collected at the start of their cancer treatment and will complete questionnaires at baseline and at weeks 4, 12, 24, and 52. Blood samples may also be collected at multiple times during the study. The study focuses on patients receiving standard-of-care ICI therapy for solid tumors, without combination chemotherapy or other non-ICI treatments. During the study, participants will complete patient-reported outcome forms and health questionnaires to assess side effects and quality of life. Researchers will monitor the occurrence of severe immune-related side effects over 52 weeks and evaluate biological markers from blood and tissue samples. The study also assesses the use of electronic methods for collecting patient data. Total participation includes assessments over approximately one year following treatment start.

Researchers are evaluating a screening and multi-sub-study randomized phase II/III trial called Lung-MAP, designed for patients with previously treated non-small cell lung cancer. The trial aims to establish a genomic screening method to assign patients to biomarker-driven or non-matched sub-studies. Depending on the cancer biomarker type, participants may receive new targeted cancer therapies or combinations compared to standard care, with the goal of approving new treatments. An optional ancillary study explores patient and physician attitudes about returning genetic findings related to germline mutations. The study involves testing patient specimens to determine eligibility for various sub-studies under the Lung-MAP protocol. Patients undergo screening to analyze tumor tissue and blood samples for biomarkers including PD-L1 and c-MET. Those requiring a fresh biopsy also submit blood for circulating tumor DNA testing. Sub-study assignment depends on the molecular profile results. This screening process includes both patients progressing after prior therapy and those pre-screened before progression on current treatment. Participants provide informed consent and tumor tissue that meets quality standards for testing. Researchers collect clinical data including smoking history and performance status. Outcomes focus on screening success, such as adequate tissue submission and matching to biomarker-driven sub-studies, tracked for up to three years. The study also monitors patient and physician knowledge and preferences regarding genomic findings. Participation duration varies based on screening and sub-study assignment.

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating targeted therapy directed by genetic testing for patients with locally advanced or advanced solid tumors that have spread to nearby tissues, lymph nodes, or other parts of the body. This research focuses on patients whose cancer has progressed despite standard treatments or for whom no standard treatment has been shown to improve survival. The trial aims to match patients to treatments based on specific genetic changes in their tumor cells, in hopes of controlling the tumor and improving treatment planning. This effort is part of the ComboMATCH program, a coordinated set of clinical trials designed to study combination therapies targeting molecularly defined patient groups. Patients undergo tumor mutational screening using previously collected samples, and those 18 years or older with disease suitable for biopsy may have a new tumor biopsy before starting treatment. Participants are assigned to one of multiple treatment subprotocols based on their tumor's genetic mutations. Treatments include various drugs taken orally, intravenously, or by injection, such as selumetinib, olaparib, fulvestrant, paclitaxel, and others, often in combination. Treatment cycles typically repeat every 28 days unless disease progression or unacceptable side effects occur. Some patients may be randomized to different treatment arms, and crossover to other arms is sometimes allowed. Procedures also include biopsies, blood collection, imaging scans (CT, MRI, PET), bone marrow aspiration, and heart function tests throughout the study. Participants are closely monitored with scans, biopsies, blood tests, and heart evaluations during treatment to assess response and safety. These assessments occur at various times, including screening, during treatment cycles, and follow-up periods that can last up to several years. Researchers measure patient enrollment rates, assignment to treatment arms, and outcomes within defined patient groups. The study also compares tumor genetic profiles from tissue and blood samples to better understand responses. Overall, the trial provides long-term observation of patients receiving personalized targeted therapies based on genetic testing results.

Researchers are evaluating whether adding pembrolizumab, a type of immunotherapy, to usual chemotherapy improves outcomes in patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer that has been removed by surgery. Pembrolizumab may help the immune system attack cancer cells and prevent tumor growth. Chemotherapy drugs like cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel work by stopping tumor cells from growing and spreading. This phase III trial compares disease-free survival between different treatment approaches involving pembrolizumab and chemotherapy. Participants are randomly assigned to one of two treatment groups. In Arm B, patients receive four cycles of chemotherapy followed by pembrolizumab given intravenously every 21 days for up to 17 cycles or every 6 weeks for 16 cycles. In Arm C, patients receive chemotherapy combined with pembrolizumab during the initial four cycles, followed by pembrolizumab alone for up to 13 cycles every 21 days or 12 cycles every 6 weeks. Chemotherapy regimens include various platinum doublets chosen by the treating physician. Arm A was closed as of February 2022. Patients may also undergo tests such as echocardiograms, MRIs, CT scans, and blood sample collections during the trial. Throughout the study, participants are monitored with regular assessments including imaging and blood tests. Follow-up visits occur 6 weeks after treatment, then every 3 months for 2 years, every 6 months for years 2-4, and annually up to 10 years after randomization. Researchers measure disease-free survival, overall survival, adverse events, drug discontinuation rates, and patient quality of life using questionnaires. The study also explores outcomes based on tumor markers like PD-L1 expression and tumor mutational burden.

Researchers are evaluating the effectiveness of neratinib alone compared to a combination of neratinib and palbociclib in treating patients with HER2 positive solid tumors, including gynecologic cancers. This phase II trial focuses on slowing or stopping tumor growth by blocking abnormal proteins that signal cancer cells to multiply. It aims to assess progression-free survival as the primary outcome and also evaluates response rates, overall survival, and treatment-related side effects. The study further explores genetic markers and tumor profiles to understand treatment response and resistance. Participants are randomly assigned to one of two treatment arms. In Arm I, patients take neratinib orally once daily on days 1-14 of an initial cycle, then continuously on days 1-28 of each subsequent 28-day cycle. Arm II follows the same initial neratinib schedule, but adds palbociclib orally once daily on days 1-21 of each subsequent cycle. Treatment continues until disease progression or unacceptable side effects occur. Patients experiencing progression on neratinib alone may switch to the combination therapy. Both arms include various scans and blood tests, with optional tumor biopsies before and during treatment. During the study, participants undergo monitoring with echocardiograms or MUGA scans, CT or MRI scans, and blood sample collections to track tumor status and treatment effects. Researchers collect tissue samples to study tumor genetics and blood-based DNA markers at baseline and follow-up. After completing treatment, patients are followed every three months for up to two years to observe long-term outcomes and safety. The total participation duration includes treatment cycles and extended follow-up for disease progression or survival assessment.