Carbone Cancer Center

Researchers are studying adults newly diagnosed with breast, colorectal, melanoma, non-Hodgkin lymphoma, or non-small cell lung cancer who are planning to receive systemic cancer therapies such as chemotherapy and immune checkpoint inhibitors ICIs. The study aims to understand how cannabis and cannabinoid use relates to cancer-related symptoms over one year. This observational research includes patients treated in community oncology clinics and is sponsored by Wake Forest University Health Sciences. Participants complete surveys and allow medical record reviews throughout the study. The study tracks cannabis and cannabinoid use as well as perceived benefits, harms, and adverse effects monthly for 12 months following enrollment. An optional sub-study is available at select sites for patients with non-small cell lung cancer receiving specific chemotherapy with ICIs. During the study, participants fill out monthly surveys about their symptoms and cannabis use. Researchers also review medical records to assess cancer-related symptoms and treatment progress. The main measure is cancer-related symptoms assessed monthly for up to one year. Secondary measures include cannabis use patterns and adverse effects. Participation involves ongoing survey completion and record review, with the total study duration lasting 12 months post-enrollment.

This research aims to gather health information from infants, children, adolescents, and young adults diagnosed with cancer to improve treatment and ongoing care. It maintains a Childhood Cancer Registry and uses clinical and biological data to identify eligibility for Childrens Oncology Group therapeutic trials. The study also develops a biorepository of biospecimens and clinical data for current and future research, including tumor and host DNA samples, and allows for future contact regarding additional research studies. Participants are assigned to one of two observational protocols. In the Project Every Child Protocol, medical data is reviewed to create a cancer registry, and biospecimens such as tissue, blood, bone marrow, plasma, serum, saliva, cerebrospinal fluid, or urine are collected. In the Project AYA Protocol, biospecimens are collected similarly. These samples are gathered at diagnosis, progression, recurrence, or post-mortem where applicable. During the study, participants undergo medical chart reviews and biospecimen collections. Researchers measure the number of patients consenting to biobanking as a primary outcome. Clinical data including diagnosis, staging, treatment summaries, and outcomes are recorded. The study involves ongoing data collection over time to support future research and screening for trial eligibility, with participation lasting as long as data and samples continue to be collected.

Researchers are studying the health of people with Down syndrome who have been treated for acute leukemia. Children with Down syndrome face higher risks of side effects during leukemia treatment, but its unclear how this affects their long-term health. The study aims to understand chronic health conditions and other lasting effects after leukemia treatment in this group to help improve their quality of life and develop better care guidelines. Participants may provide saliva or buccal swab samples, undergo clinical assessments, and, if they have Down syndrome-associated acute lymphoblastic leukemia, may also give blood samples and complete neurocognitive tests. These evaluations are done in parts, including biospecimen collection, clinical evaluation, and neurocognitive assessment. During the study, participants will be assessed for chronic health conditions, neuropsychological outcomes reported by parents, health-related quality of life, and clinical risk factors. Researchers will also create a detailed group of survivors and a biobank for future research. The main outcome measured is the prevalence, type, and severity of chronic health conditions. The study will continue until June 2029, with ongoing assessments and data collection.

Researchers are evaluating the safety, side effects, and best dose of a combination of two anti-cancer drugs, neratinib and trastuzumab deruxtecan, in patients with advanced solid tumors that have spread or cannot be removed by surgery and have changes in the HER2 gene. This phase I trial aims to determine the maximum tolerated dose, assess tumor response, and study the drugs effects on tumor markers and overall survival in this patient population. Participants receive neratinib orally once daily on specified days of each 21-day cycle and trastuzumab deruxtecan intravenously over 30 to 90 minutes on day 1 of each cycle. Treatment cycles repeat every 21 days unless disease progression or unacceptable side effects occur. The study includes dose-escalation and dose-expansion phases, with possible tissue biopsies at various points to evaluate tumor changes and drug impact. Throughout the study, participants undergo blood sample collection, CT scans, and heart function tests via echocardiography or MUGA scans. Biopsies may be performed at baseline, during the study, or at disease progression depending on the cohort. After treatment ends, patients are followed every three months for at least one year to monitor health and survival outcomes. Researchers measure treatment safety, tumor response rates, duration of response, progression-free survival, and drug concentrations over this period.

Researchers are evaluating the addition of pembrolizumab immunotherapy to standard chemotherapy for patients with stage IIA, IIB, IIIA, or IIIB non-small cell lung cancer NSCLC that has been completely removed by surgery. This phase III trial aims to compare disease-free survival and overall survival among different treatment approaches, including chemotherapy alone, chemotherapy followed by pembrolizumab, and chemotherapy combined with pembrolizumab. The study also assesses quality of life and adverse event rates in these patient groups. Participants are randomly assigned to one of three groups. One group receives only chemotherapy with observation afterward. The other two groups receive chemotherapy followed by pembrolizumab or chemotherapy combined with pembrolizumab. Chemotherapy involves one of four platinum doublet regimens administered every 21 days for four cycles, depending on the physicians choice. Pembrolizumab is given intravenously over 25-40 minutes, either after chemotherapy or alongside it, repeated every 21 days or every 6 weeks for multiple cycles. Patients also undergo heart ultrasound, MRI, CT scans, and blood sample collections as part of the study. During the trial, participants have regular medical assessments including imaging and blood tests to monitor their health. 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 from randomization. Researchers measure disease-free survival as the main outcome, tracking the time until cancer recurrence or death. They also evaluate overall survival, side effects, drug tolerability, and patient-reported quality of life over time.

Researchers are investigating treatments for men with prostate cancer that has returned after surgery, focusing on those who experience a rise in prostate-specific antigen PSA levels, indicating biochemical recurrence. The study examines whether adding enhanced systemic therapy apalutamide combined with abiraterone and prednisone to standard care, which includes prostate radiation therapy and short-term androgen deprivation, improves outcomes. Additionally, for patients whose cancer has spread beyond the pelvis as detected by PET imaging, the study evaluates the benefit of adding metastasis-directed radiation therapy. Participants undergo baseline PETCT or PETMR scans to determine the extent of cancer spread. Based on these results, they are randomized into one of four treatment arms standard radiation with androgen deprivation, enhanced therapy including apalutamide, or enhanced therapy plus targeted radiation for metastatic disease. Treatments involve various forms of radiation therapy, androgen deprivation drugs, and oral apalutamide, administered over six months in the absence of disease progression or unacceptable side effects. Some patients may receive repeat PET scans to assess treatment response. During the study, participants have scheduled assessments including imaging, blood tests measuring PSA levels, and quality-of-life questionnaires over up to ten years. Follow-up visits occur every three months for the first two years, then less frequently up to ten years. Researchers monitor progression-free survival, overall survival, event-free survival, PSA progression, adverse events, and quality of life measures including cognitive function and fatigue. This long-term monitoring aims to determine the effectiveness of the added therapies compared to standard treatment alone.

Researchers are comparing two treatments for children and young adults aged 2 to 21 with newly diagnosed or untreated low-grade glioma LGG that does not have a BRAFV600E mutation or neurofibromatosis type 1 NF1. The study aims to find out if selumetinib, a drug that blocks enzymes needed for tumor cell growth, works as well as the standard chemotherapy treatment with carboplatin and vincristine CV. It also evaluates which treatment better improves quality of life and patient outcomes. Participants are randomly assigned to one of two groups. One group receives vincristine intravenously on specific days along with carboplatin intravenously on scheduled days, followed by maintenance cycles every 42 days for up to 8 cycles. The other group takes selumetinib orally twice daily in 28-day cycles for up to 27 cycles. Throughout the trial, patients undergo blood collection, MRI scans, and in the selumetinib group, echocardiography at baseline. Treatments continue unless there is disease progression or unacceptable side effects. During participation, patients have various assessments including tumor imaging, blood tests, and evaluations of vision and motor function. Quality of life and cognitive, social, emotional, and behavioral functions are also measured. After treatment, patients are followed every 3 months for the first year, every 6 months for years 2 and 3, and then annually up to 10 years. The main outcome measured is event-free survival over this period.

Researchers are evaluating whether the drugs mosunetuzumab and polatuzumab vedotin can provide benefits for patients with diffuse large B-cell lymphoma or grade 3b follicular lymphoma that has returned or not responded to treatment. This study focuses on patients who have already received chemotherapy with fludarabine and cyclophosphamide, followed by CAR T-cell therapy. The goal is to determine if adding these drugs after previous treatments may better control or shrink the cancer. Participants first receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by one of three CAR T-cell therapies given by infusion tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel. After this, participants are randomly assigned to one of four groups receiving mosunetuzumab alone, polatuzumab vedotin alone, both drugs together, or observation without further drug treatment. Those in the observation group who experience disease progression within 12 months may switch to receive both drugs. Throughout the study, patients undergo PET-CT or CT scans and provide blood and tissue samples for research. Participants will be monitored regularly with imaging scans and laboratory tests to assess disease status and treatment effects. Researchers will measure progression-free survival, overall survival, remission rates, and treatment side effects up to two years. The study also includes collecting and banking tissue samples and PET-CT images for future research. The total length of involvement depends on individual timelines but includes treatment and follow-up periods extending up to two years or more.

Researchers are studying very low-risk and low-risk fusion negative rhabdomyosarcoma, a type of soft tissue cancer, to maintain excellent treatment outcomes while reducing therapy burdens. This phase III trial also evaluates how well patients with certain DNA mutations respond to different chemotherapy regimens and examines the use of centralized molecular risk stratification in treatment planning. The study aims to improve outcomes by adjusting therapy intensity based on molecular features. Patients are assigned to one of three treatment regimens based on their risk level and mutation status. Very low-risk patients receive vincristine and dactinomycin over 24 weeks in 8 cycles. Low-risk patients receive 12 weeks of vincristine, dactinomycin, and cyclophosphamide followed by 12 weeks of vincristine and dactinomycin, totaling 8 cycles. Patients with MYOD1 or TP53 mutations switch to an intensified 12-13 cycle regimen including vincristine, dactinomycin, and cyclophosphamide. Radiation therapy may be given at cycle 5 for some patients. Treatments are administered intravenously every 21 days. Throughout the study, participants undergo CT scans, MRI, bone scans, PET scans, and tumor biopsies to monitor disease status. Blood and tissue samples are collected at various times for research purposes. Researchers measure failure-free survival and overall survival over several years to assess treatment success. The trial lasts up to five years with ongoing assessments to track patient outcomes and safety.

Researchers are investigating targeted therapies directed by genetic testing for patients with locally advanced or advanced solid tumors that have spread or progressed after standard treatments. This Phase 2 screening trial, called ComboMATCH, aims to match patients to specific combination treatments based on genetic mutations found in their tumor cells. The study seeks to improve treatment planning by using genetic information to guide therapy choices. Patients undergo tumor genetic screening using previously collected samples or a new biopsy if eligible and aged 18 or older. Based on their tumors genetic profile, patients are assigned to one of multiple treatment subprotocols involving different drug combinations. Treatments include oral, intravenous, and intramuscular drugs such as selumetinib, olaparib, fulvestrant, binimetinib, and others. Treatment cycles generally repeat every 28 days until disease progression or unacceptable toxicity. Patients may also undergo biopsies, blood collection, imaging scans CT, MRI, PET, echocardiograms, and bone marrow procedures as part of the study. Throughout the trial, participants have regular assessments including tumor biopsies, blood draws, imaging tests, and heart function monitoring. These evaluations occur during screening, treatment, and follow-up periods. Researchers measure patient enrollment, assignment to treatment arms, and treatment outcomes over up to 8 years. Safety is monitored via clinical evaluations and diagnostic tests. This comprehensive approach aims to evaluate responses to targeted therapies guided by tumor genetics for advanced solid tumors.