Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.
A Phase 2 Study of the JAK1/JAK2 Inhibitor Ruxolitinib With Chemotherapy
in Children With De Novo High-Risk CRLF2-Rearranged and/or JAK
Pathway–Mutant Acute Lymphoblastic Leukemia
A study of the safety and efficacy of ruxolitinib with routine chemotherapy for children with leukemia with specific genetic changes.
A diagnosis of leukemia, specifically de novo high B-ALL with eligible genetic changes. Age must be greater than 1 year old and less than or equal to 21 years old at leukemia diagnosis. Have completed an acceptable induction therapy either on study or by hospital standard of care.
Exclusion Criteria:
Had any other chemotherapy before induction therapy, with exceptions. Down Syndrome.
Women In Steady Exercise Research - Neoadjuvant Exercise Trial
The primary purpose of this pilot study is to determine whether breast cancer patients whom elect to undergo cardiotoxic neoadjuvant chemotherapy can be enrolled and retained in a 6 month at home aerobic exercise training study. Using a randomized controlled trial approach, we will examine the safety and efficacy of a well monitored moderate-to-high intensity aerobic training program completed at home in breast cancer patients receiving neoadjuvant chemotherapy. In addition to assessing safety and efficacy of the program, we will assess intervention effects on cardiopulmonary fitness, cardiac function, and tumor response.
Relapsed or refractory B-cell or T-cell ALL after multi-agent chemotherapy(≥ 5% marrow lymphoblasts, assessed by morphology and flow cytometry ECOG performance status 0-2 Creatinine clearance of at least 50 mL/min within 7 days prior to first dose of study agent Adequate liver function with AST/ALT less than 3X upper limit of normal and total bilirubin less than 2 mg/dL within 7 days prior to first dose of study agent Circulating WBC count must not be above 20 x10^9/L within 7 days prior to first dose of study agent
Exclusion Criteria:
Pregnant or breast-feeding due to risk of fetal harm by the chemotherapeutic agents prescribed in this protocol Evidence of isolated extramedullary relapse (i.e., testicular or CNS) Serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled Poorly controlled HIV, or CD4 < 400. HIV positive patients are allowed on this study if they have a CD4 count greater than or equal to 400, and are on a stable antiviral regimen Patients with NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled
Site for Cabazitaxel with Abiraterone versus Abiraterone alone Randomized Trial for Extensive Disease following Docetaxel: the CHAARTED2 Trial
To assess whether the addition of 6 cycles of cabazitaxel to
abiraterone acetate in patients with CRPC that have previously
received docetaxel and ADT for HSPC can improve PFS compared to
abiraterone acetate alone.
Age ≥ 18 years Histologically confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate). Previous chemotherapy with at least 3 cycles of docetaxel for hormone-sensitive metastatic prostate cancer. Metastatic disease as evidenced by the presence of soft tissue and/or bone metastases on imaging studies (CT/MRI of abdomen/pelvis, bone scintigraphy or NaF PET/CT). Ability to swallow abiraterone acetate tablets as a whole.
Exclusion Criteria:
Any prior chemotherapy or AR-directed therapy for CRPC, (e.g. docetaxel, cabazitaxel, mitoxantrone, abiraterone Pure small cell or other variant (non-adenocarcinoma) prostate cancer histology for which treatment with abiraterone would not be considered appropriate. Patients may not be receiving other therapeutic investigational agents or be receiving concurrent anticancer therapy other than standard androgen deprivation therapy. Any medical condition for which prednisone (corticosteroid) is contraindicated. Active infection requiring treatment with antibiotics.
A phase III, multicenter, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]: NATALEE).
This is a drug study that will examine the drug Ribociclib with endocrine therapy versus just endocrine therapy in patients with early breast cancer.
Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis within 18 months prior to randomization Patient has breast cancer that is positive for ER and/or PgR Patient has HER2-negative breast cancer defined as a negative Patient has available archival tumor tissue from the surgical specimen, for submission to a central laboratory. If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according to the institutional guidelines
Exclusion Criteria:
Patient has received any CDK4/6 inhibitor Patient has received prior treatment with tamoxifen, raloxifene or AIs Patient has received prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin. h a known hypersensitivity to any of the excipients of ribociclib and/or ET ( Patient with distant metastases of breast cancer beyond regional lymph nodes
Site for EA9161: A Randomized Phase III Study of the addition of
Venetoclax to Ibrutinib and Obinutuzumab versus Ibrutinib
and Obinutuzumab in Untreated Younger Patients with
Chronic Lymphocytic Leukemia (CLL)
The is a drug study to compare the progression free
survival of the three drug combination Ibrutinib-Obinutuzumab-Venetoclax (IOV) to Ibrutinib-Obinutuzumab (IO) in untreated CLL patients younger than 70 years of age.
Diagnosis of CLL according to the NCI/IWCLL criteria or SLL according to the WHO criteria Negative FISH analysis for t(11;14)(IgH/CCND1) on peripheral blood or tissue biopsy Age ≥ 18 years and < 70. ECOG performance status between 0-2. Life expectancy of ≥ 12 months.
Exclusion Criteria:
No deletion of 17p13 on cytogenetic analysis by FISH No active hemolytic anemia requiring immunosuppressive therapy or other pharmacologic treatment. No current use of corticosteroids. No previous autoimmune complications No other active primary malignancy
Histologic documentation of women or men with HER2 negative breast carcinoma and free of recurrence. Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined by the treating physician, is allowed. Age > 18 and < 70 years of age. ECOG performance status 0-2. Patients with a prior history of gastric/duodenal ulcers documented on endoscopy can be enrolled as long as the ulcers did not cause bleeding requiring a blood transfusion/major intervention.
Exclusion Criteria:
No history of GI bleeding requiring a blood transfusion, endoscopic or operative intervention. No history of any prior stroke (hemorrhagic or ischemic). No concurrent anticoagulation with warfarin, heparin/heparin analogues, clopidogrel, direct thrombin inhibitors, or direct factor XA inhibitors. No history of atrial fibrillation or myocardial infarction. No history of grade 4 hypertension, defined as hypertension resulting in lifethreatening consequences
Using Exercise to Relieve Arthralgia (Joint Pain) and Improve AI Adherence in Older Survivors (REJOIN): A Pilot Study
Briefly, the purpose of this study is to use a self-management approach (combining education and exercise) to help older breast cancer survivors manage joint pain, a common side effect of aromatase inhibitors (AIs), a medication used to reduce hormones that might increase risk of recurrence and mortality following primary cancer treatment. We believe that reducing joint pain might help survivors take their medication longer and thus improve survival outcomes, compared to standard care.
Age 60 and older Female Breast Cancer Survivor Preparing to Start AI medication ER+ diagnosis
Exclusion Criteria:
Already taking AI medication (greater than 24 weeks) Gross Cognitive Impairment Recent Joint Surgery Cardiac event/Stroke within last 6 months Not willing to come to HMC for Exercise Sessions
Phase II Study of Bendamustine and Rituximab plus Venetoclax in Untreated Mantle Cell Lymphoma over 60 Years of Age
This study is to see if venetoclax in combination with bendamustine and rituximab chemotherapy is effective in treating people who have mantle cell lymphoma and to examine the side effects, good and bad, associated with this combination .
Must have histologically confirmed (biopsy-proven) diagnosis of mantle cell lymphoma (MCL) Must have measurable or evaluable disease as defined as a lymph node measuring >1.5 cm in any dimension or splenomegaly with spleen >15 cm in craniocaudal dimension ECOG performance status of 0-2 Adequate organ function as measured by the criteria Total Bilirubin ≤ 1.5x upper limit of normal (ULN) or ≤ 3x ULN with documented Gilbert’s syndrome
Exclusion Criteria:
Should not have known evidence of central nervous system (CNS) lymphoma Should not have prior chemotherapy, radiotherapy or immunotherapy for lymphoma Must not have received a prior allogeneic stem cell transplant or solid organ transplant (except for cornea) for any indication Must have no active, uncontrolled infections Must not have active hepatitis B or be chronic carriers of hepatitis B.
Site for Phase III Study of Daratumumab/rHuPH20 (NSC-810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study) (PSCI# 19-079) (S1803)
This study is being done to answer the following questions:
1. Will adding the drug daratumumab/rHuPH20 to the usual maintenance treatment with lenalidomide after stem cell transplant help multiple myeloma patients survive longer?
2. For patients who have no evidence of multiple myeloma in their bone marrow (patients who do not have “minimum residual disease” [MRD-negative]), should maintenance therapy be stopped after 2 years?
We are doing this study because we want to find out if this approach is better or worse than the usual approach for your multiple myeloma. The usual approach is defined as care most people get for multiple myeloma.
Patients must have had a confirmed diagnosis of symptomatic multiple myeloma (See Section 4.1) that required systemic induction therapy prior to autologous stem cell transplantation (ASCT). Patients with disease measurable by serum light chain assay alone are eligible (defined as ≥ 100 mg/L on involved light chain). Patients must be ≥ 18 and ≤ 75 years of age at time of registration to Step 1. Patients must have history and physical exam within 28 days prior to registration. Patients must have Zubrod Performance Status ≤ 2.
Exclusion Criteria:
Patients with smoldering myeloma are not eligible Patients must not have any organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction. Patients must not have progressive disease at any time prior to registration. Patients must not be refractory or intolerant to either lenalidomide or daratumumab/rHuPH20. Patients must not have moderate or severe persistent asthma within the past 2 years and must not have currently uncontrolled asthma of any classification.
A151216-Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (Alchemist)
Purpose of study is to examine lung cancer patients' surgically removed tumors for certain genetic changes and to possibly refer these patients to a treatment study with drugs that may specifically these tumors.
Surgically resected non-small cell lung cancer Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size ≥4 cm). Tissue available for the required analyses
Exclusion Criteria:
No patients with recurrence of lung cancer after prior resection No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD1/PD-L1/CTLA-4.
Site for A Randomized Phase II/III Trial of De-intensified Radiation Therapy for Patients with Early-Stage, P16-Positive, Non-Smoking Associated Oropharyngeal Cancer (NRG-HN005) (PSCI# 20-011)
The purpose of the first part of this study is to compare the usual treatment of a standard-dose radiation given over 6 weeks with cisplatin chemotherapy to a reduced-dose radiation given over either 6 weeks with cisplatin or 5 weeks with the immunotherapy drug, nivolumab. A lower dose of radiation as compared to the usual radiation treatment dose could be as effective in lengthening the time without your cancer getting worse. Nivolumab with reduced-dose radiation may or may not be as effective in lengthening the time without your cancer getting worse.
This study will help the study doctors find out if this different approach is the same or worse than the usual approach.
Pathologically proven diagnosis of squamous cell carcinoma of the oropharynx Patients must have clinically or radiographically evident measurable disease at the primary site or at nodal stations P16-positive based on local site immunohistochemical tissue staining Zubrod Performance Status of 0-1 within 14 days prior to registration Only English, Spanish, or French speaking patients are eligible to participate as these are the only languages for which the mandatory dysphagia-related patient reported instrument (MDADI) is available
Exclusion Criteria:
Clinical stages T0; T4; T1-2, N0; or any N2 (AJCC, 8th ed) Recurrent disease Definitive clinical or radiologic evidence of metastatic disease or adenopathy below the clavicles Cancers considered to be from an oral cavity site or the nasopharynx, hypopharynx, or larynx, even if p16-positive, or histologies of adenosquamous, verrucous, or spindle cell carcinomas Carcinoma of the neck of unknown primary site origin (T0 is ineligible, even if p16-positive)
A Phase Ib/II Study of APG-115 in Combination with Pembrolizumab in Patients with Unresectable or Metastatic Melanomas or Advanced Solid Tumors
Part 1 (Phase Ib): To determine the safety and ability for subjects to tolerate APG-115 when combined with pembrolizumab, as well as the maximum tolerated dose in subjects with metastatic melanomas or solid tumors.
Part 2 (Phase II): To determine the overall response rate of APG-115 when combined with pembrolizumab in the treatment of patients with unresectable or metastatic melanomas.
Male or non-pregnant, non-lactating female patients age ≥18 years on day of signing the informed consent Histologically confirmed, unresectable or metastatic melanoma, and refractory or relapse after PD1 antibody treatment and ineligible for other standard of care therapy ECOG Performance scale of 0-2 Life expectancy of equal to or greater than 3 months Adequate bone marrow and organ functionAdequate
Exclusion Criteria:
Any prior systemic MDM2-p53 inhibitor treatment Received chemotherapy within 21 days (42 days for nitrosoureas or mitomycin C) prior to first dose. Prior loco-regional treatment with intralesional therapy (e.g. talimogene laherparepvec) for unresectable or metastatic melanoma in the last 6 months prior to start of study treatment. Received hormonal and biologic (<1 half-lives), small molecule targeted therapies or other anti-cancer therapy within 21 days prior to first dose Radiation or surgery within 14 days of study entry, thoracic radiation within 28 days prior to first dose. Has known active central nervous (CNS) metastases and/or carcinomatous meningitis. Or has neurologic instability per clinical evaluation due to tumor involvement of the CNS. Requirement for corticosteroid treatment, with the exception of megestrol, local use of steroid: i.e.: topical corticosteroids, inhaled corticosteroids for reactive airway disease, ophthalmic, intraarticular, and intranasal steroids.
A Phase 3, Randomized, Placebo-Controlled Clinical Study to Evaluate the Safety and Efficacy of Stereotactic Body Radiotherapy (SBRT) with or without Pembrolizumab (MK-3475) in Participants with Unresected Stage I or II Non-Small Cell Lung Cancer (NSCLC) (KEYNOTE-867) (MK 3475-867)
This Phase 3 study is to compare the Event Free Survival (EFS) of using SBRT in combination with pembrolizumab and compared to SBRT in combination with placebo. To compare Overall Survival (OS) of using SBRT in combination pembrolizumab and compared to SBRT in combination with placebo.
Has an ECOG Performance Status of 0, 1, or 2. Has previously untreated NSCLC diagnosed by histology or cytology and confirmed as Stage I or IIA NSCLC (AJCC 8th edition) by chest CT and PET scan. Cannot undergo thoracic surgery due to existing medical illness(es) A female is eligible to participate if she is not pregnant and not breastfeeding Is male or female ≥18 years of age
Exclusion Criteria:
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor Has received prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or breast Has received a live vaccine within 30 days prior to the first dose of study drug. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Site for MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK) (S1827) (PSCI# 20-086)
The purpose of this study is to compare the effects of using brain MRIs alone versus brain MRIs plus PCI on the lifespan of patients with small cell lung cancer. The use of brain MRIs alone could reduce side effects of receiving PCI.
This study is hoping to show that monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) is at least as good as the combination of PCI with MRI scans.
There will be about 668 people taking part in this study.
Patient must have a histologically confirmed diagnosis of small-cell lung cancer (SCLC). Patient must have an MRI of the brain performed within 28 days prior to registration. Patient must have Zubrod Performance Status of 0-2 Patient must be ≥ 18 years of age. All adverse events from prior treatment must have resolved to ≤ Grade 2 (CTCAE Version 5.0) prior to randomization.
Exclusion Criteria:
Patient must not have a contraindication to gadolinium contrast administration during MR imaging, such as allergy or insufficient renal function Patient must not have other metastatic malignancies requiring current active treatment. Patient must not have any severe active comorbidities Patient must not have received prior radiotherapy to the brain or whole brain radiotherapy. Patient must not have a contraindication to MR imaging, such as implanted metal devices or foreign bodies
Nurse AMIE for Echo Show: Randomized Control Trial
The Nurse AMIE platform has been modified to work as an Amazon Alexa Skill for use on the Echo Show device. We will recruit women receiving treatment for metastatic breast cancer and randomize them to receive standard treatment (control) or the Nurse AMIE for Echo Show program. Nurse AMIE is a supportive care program for women undergoing chemotherapy and helps them to manage their symptoms. We will test the feasibility of using the Nurse AMIE program as well as its effectiveness at managing symptoms.
Female patient with metastatic breast cancer At least 18 years of age Personal in-home wi-fi access Personal device capable of receiving telephone calls for weekly check-ins Fluent in written and spoken English
Exclusion Criteria:
ECOG Performance Score of >2 Significant medical or psychiatric conditions (beyond breast cancer) Receiving any behavioral intervention Pregnant Life expectancy of less than 6 months
Site for Phase II, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell Lung Cancer
This study is to determine the overall response rate (ORR) of telisotuzumab vedotin in subjects with c-Met+ non-small cell lung cancer.
Adult male or female, at least 18 years old Subjects must have c-Met+ NSCLC as assessed by an AbbVie designated IHC laboratory or known documented MET gene amplification Subjects have adequate bone marrow, renal, and hepatic function Subjects are willing and able to comply with procedures required in this protocol Subjects have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Exclusion Criteria:
Subjects must not have a history of major immunologic reaction to any IgG containing agent Subjects must not have psychiatric illness/social situation that would limit compliance with the study Subjects must not have any medical condition which in the opinion of the Investigator or Therapeutic Area Medical Director (TA MD) places the subject at an unacceptably high risk for toxicities Subjects must not have received any live vaccine within 30 days of the first dose of investigational product Subjects must not have had major surgery within 21 days prior to the first dose of telisotuzumab vedotin
Site for A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer (NRG-BR004) (PSCI# 20-136).
The purpose of this study is to compare the usual treatment plus placebo to the usual treatment plus atezolizumab. The addition of atezolizumab to the usual treatment could stabilize your cancer.
This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the atezolizumab lengthens the time during and after the treatment of your cancer that you live with your cancer and it is stable.
Atezolizumab is already approved by the FDA for use in non-small cell lung cancer and urinary cancer. Its use in this study is considered experimental. There will be about 600 people taking part in this study.
Patient must have an ECOG Performance Status of 0 or 1 Histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease, or metastatic disease Adequate hematologic function within 14 days prior to randomization Localized palliative radiation therapy is allowed for symptom management if completed 14 days or more prior to randomization Adequate renal function determined within 14 days prior to randomization
Exclusion Criteria:
Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded History of exposure to cumulative doses of doxorubicin greater than 360 mg per square meter of body surface area or its equivalent Prior treatment with mTOR inhibitors or CDK 4/6 inhibitors in combination with endocrine therapy for treatment of metastatic disease History of asymptomatic LVEF decline to < 40% during or after prior HER2-targeted therapy Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including antiCD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
Site for NRG-LU002: MAINTENANCE SYSTEMIC THERAPY VERSUS LOCAL CONSOLIDATIVE THERAPY (LCT) PLUS MAINTENANCE SYSTEMIC THERAPY FOR LIMITED METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC): A RANDOMIZED PHASE II/III TRIAL (PSCI# 21-028)
The purpose of this research study is to compare any good and bad effects of using the usual drug therapy plus radiation with or without surgery to treat the lung cancer and areas of metastasis (where the cancer has spread) compared with the usual drug therapy alone. Two types of radiation delivery will be used in this study. One type is called stereotactic body radiation therapy (SBRT) and will be used to treat areas of metastasis (parts of your body where the cancer has spread). SBRT uses special equipment to position a patient and precisely deliver radiation to tumors in the body. The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. The second type is standard radiation therapy and may be used to treat your primary lung tumor if SBRT cannot be used.
Surgery also may be used to treat metastases or your primary lung tumor if you and your treating doctor decide this is a safe and better approach.
Radiation, surgery, and usual drug therapy have already been tested for safety; however, using them in combination is not part of the usual approach. Adding radiation with or without surgery to the usual drug therapy could shrink or remove your tumor(s) or prevent the tumor(s) from returning but it could also cause side effects. This study will allow the researchers to know whether this different approach is better, the same, or worse than the usual therapy alone approach. Ultimately, to be better, the study treatment should increase life by six months or more compared to chemotherapy alone.
Pathologically proven diagnosis of NSCLC, with metastases (stage IV disease) present prior to registration. Age = 18; Zubrod Performance Status 0, 1, or 2 within 30 days prior to registration; Adequate organ and hematologic/bone marrow function within 14 days prior to registration Negative serum pregnancy test within one week prior to registration for females of childbearing potential
Exclusion Criteria:
Prior bevacizumab therapy is excluded. Clinical or radiologic evidence of new, untreated, and/or progressive brain metastases prior to registration after induction systemic therapy Cutaneous metastasis of NSCLC; Metastatic disease invading the esophagus, stomach, intestines, or mesenteric lymph nodes if not a candidate for surgery for these lesions; Prior invasive malignancy (except non-melanomatous skin cancer, low or intermediate risk prostate cancer, or in situ carcinoma of breast, oral cavity, skin, or cervix) unless disease free for a minimum of one year
Site for Randomized Phase III Trial of MEDI4736 (durvalumab) as
Concurrent and Consolidative Therapy or Consolidative
Therapy Alone for Unresectable Stage 3 NSCLC (EA5181) (PSCI# 21-041).
The purpose of this study is to compare the usual approach of chemo/radiation followed by one year of MEDI4736 (durvalumab) to chemo/radiation with MEDI4736 (durvalumab) followed by one year of MEDI4736 (durvalumab). The addition of MEDI4736 (durvalumab) during chemo/radiation could prevent your cancer from returning and extend your life. But, it could also cause side effects.
This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study drug extends the life of patients and/or prevents the tumor from coming back as compared to the usual approach.
This drug, MEDI4736 (durvalumab), is already approved by the FDA for use in other cancers, and for use in your type of cancer after the completion of chemotherapy and radiation. At this time MEDI4736 (durvalumab) is not yet approved (experimental) when given with chemotherapy and radiation. There will be about 660 people taking part in this study.
Patient must be = 18 years old. Patient must have an ECOG Performance Status of 0 or 1. Body weight > 30 kg of patients. Patient must not have unintentional weight loss > 10% within 30 days prior to registration. Patient must have a baseline ECG obtained within 6 weeks of registration.
Exclusion Criteria:
Patient must not have any active, known or suspected autoimmune disease and neuromuscular paraneoplastic syndromes Patient must not have a history of active hepatitis B (chronic or acute) or hepatitis C infection. Patient must not have a known active tuberculosis infection. Patient must not have any severe infections within 4 weeks prior to registration including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia. Patient must not have signs or symptoms of severe infection (sepsis) within 2 weeks prior registration.
DuRvalumab MEDI4730 with chEmotherapy as first line treAtment in advanced pleural Mesothelioma A phase 3 Randomised trial (DREAM3R) (PrE0506)(PSCI#20-123)
Participants may receive the medication Durvalumab in addition to standard of care medications or standard of care medications alone for treatment of Mesothelioma.
unable to surgically remove pleural mesothelioma post menopausal or negative pregnancy test greater than 66 pounds in weight life expectancy of at least 12 weeks
Exclusion Criteria:
prior chemotherapy autoimmune disease metastasized to the brain
Patient must be > 18 years of age Patient must be able to undergo a diagnostic bone marrow aspirate following registration to Step 0. Patient must not be on other concurrent chemotherapy, or any ancillary therapy considered investigational. Patient must not have uncontrolled psychiatric illness or social situations that would limit compliance with study requirements Patient must have been able to maintain at least 10 mg dose of lenalidomide without growth factor support.
Exclusion Criteria:
Patients who have a Grade 2 or higher diarrhea per CTCAE in the absence of antidiarrheals. Patient who have uncontrolled intercurrent illness. Patients who have Grade 2 or higher peripheral neuropathy or grade 1 peripheral neuropathy with pain per CTCAE. Women who are pregnant due to potential harm to the fetus from ixazomib and lenalidomide. Patients who are on other concurrent chemotherapy, or any ancillary therapy considered investigational.
Site for Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE) (PSCI# 21-217) (NRG-GU010)
The purpose of this study is to use the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient’s cancer aggressiveness.
The study will test your tumor tissue for many different genes that all together indicate the risk of your cancer spreading; this is called the Decipher risk score.
If you have a higher Decipher risk score, you will be assigned to the part of the study that compares the use of 6 months of hormone therapy and radiation treatment (usual treatment) to the use of darolutamide (BAY 1841788) plus the usual treatment. The purpose of this study is to determine whether the additional drug can reduce the chance that your cancer will come back and spread.
Age ≥ 18 ECOG Performance Status of 0-2 within 120 days prior to registration; For patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months
Exclusion Criteria:
Definitive clinical or radiologic evidence of metastatic disease Previous bilateral orchiectomy Prior radiotherapy to the prostate/pelvis region that would result in overlap of radiation therapy fields. Active testosterone replacement therapy; any replacement therapy must be stopped at least 30 days prior to registration Inability to swallow oral pills.
An International Prospective Open-label, Randomized, Phase III Study comparing 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with Metastatic hormone Sensitive Prostate Cancer (mHSPC)
The purpose of this study is to evaluate the efficacy and safety of 177Lu-PSMA-617 in combination with Standard of Care, versus Standard of Care alone, in adult male patients with mHSPC.
Patients must have metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma (current or prior biopsy of the prostate and/or metastatic site) Patients must have an ECOG performance status of 0 to 2 Patients must be adults >= 18 years of age Patients must have evidence of PSMA-positive disease as seen on a 68Ga-PSMA-11 PET/CT scan
Exclusion Criteria:
Patients with rapidly progressing tumor that requires urgent exposure to taxane-based chemotherapy Patients with CNS metastases that are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity Patients with a history of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study Patients with symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression Patients who received transfusion for the sole purpose of making a subject eligible for study inclusion
A diagnosis of pediatric cancer of varying types for which there is no known cure or disease that is not responding to treatment. Must be over one year of age at enrollment. Must be less than or equal to 21 years at initial diagnosis. Must have measurable disease by accepted standards. Tumor must be accessible for biopsy.
Exclusion Criteria:
Has received chemotherapy within the last 7 days of biopsy. Has received any radiotherapy to the primary sample site within the last 14 days. Currently taking any other study drug.
A Phase II Trial of Nifurtimox for Refractory or Relapsed Neuroblastoma and Medulloblastoma
A study if the safety and effectiveness of nifurtimox in children with neuroblastoma or medulloblastoma, that has returned or is not responding to treatment.
Ages 0-21 years at the time of diagnosis. Diagnosis of neuroblastoma or medulloblastoma. Disease has not responded to previous treatment. Disease is measurable bu accepted tests.
Exclusion Criteria:
Patients who weigh less than 3.5 kg (7.7 lbs). Currently receiving another study drug. Currently receiving other anticancer agents.
A confirmed diagnosis of neuroblastoma. Must be in complete remission (CR). Tests and scans will be required to confirm remission.
Exclusion Criteria:
Patients below the defined minimum of height and weight. Patients who are currently receiving another study drug may not participate. Patients who are currently receiving other anticancer agents may not participate.
Diagnosis of relapsed or refractory solid tumor. Age 6 months to less than 30 years at enrollment. Must be fully recovered from effects of previous treatment. Life expectancy greater than or equal to 3 months.
Exclusion Criteria:
Prior treatment with carfilzomib. Known allergy to Captisol®. Down syndrome.
Nurse AMIE: A tablet based supportive care platform in Metastatic Breast Cancer (AMIE = Addressing Metastatic Individuals Everyday)
We propose to build and test a software program called Nurse AMIE (Addressing Metastatic Individuals Everyday) to be provided to Stage IV breast cancer patients on an electronic tablet. This program will be tested in 50 Stage IV breast cancer patients who live within the Penn State Cancer Institute’s 28 county catchment area.
Goals of the Nurse AMIE are to regularly assess mental-health, physical health, and other symptom related needs among Stage IV breast cancer patients and to provide appropriate help via videos, weekly calls (face to face, tablet to tablet) with a patient guide at Penn State, and appropriate referrals to phone or in person visits (as needed). The proposed Nurse AMIE software program will allow for the plan of resources (videos, audio files, exercises) to help with many of the common symptoms and challenges experienced by the patients. This is an identified need on the part of both the patients and their medical care teams. Finally, it will also allow patient guides to check in with patients, review responses to surveys, decide whether new or different documents or videos are needed, and connecting the patient to palliative care and other services if additional care is found to be needed.
metastatic breast cancer ECOG<3 English speaking sufficient vision/hearing or family support
Exclusion Criteria:
Medical or psychiatric conditions (beyond breast cancer, its treatment, and its symptoms) that would impair our ability to test study hypotheses (e. g. psychotic disorders, dementia, inability to give informed consent or follow the instruction). Patients who are receiving any other behavioral intervention