Search Results
PSCI 23-012 THE JANUS RECTAL CANCER TRIAL: A RANDOMIZED PHASE II TRIAL TESTING THE EFFICACY OF TRIPLET VERSUS DOUBLET CHEMOTHERAPY TO ACHIEVE CLINICAL COMPLETE RESPONSE IN PATIENTS WITH LOCALLY ADVANCED RECTAL CANCER
This trial is using long course chemoradiation in combination with three different chemotherapy treatments to treat rectal cancer. Once therapy is completed patients will either have surgery or watch and wait. The goal is to see which therapy is better in achieving a complete response, if any.
Patients will be expected to come to the clinic for all radiation treatments and all chemotherapy treatments.
Tumor Site: Rectum; ≤ 12cm from the anal verge
No prior systemic chemotherapy, targeted therapy, or immunotherapy; or radiation therapy administered as treatment for colorectal cancer within the past 5 years is allowed.
Not pregnant and not nursing,
Age ≥ 18 years
No recurrent rectal cancer; prior transanal excision, prior distal sigmoid cancer with a low anastomosis
No known mismatch repair deficient rectal adenocarcinoma
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.
Patients will be registered to the trial after surgical intervention. One vial of peripheral blood and a tissue block (or scrolls) will be submitted to the study. Once testing is completed, subject is notified if they are eligible for one of the sub protocols.
Pathologic stage IIIA, II (IIA or IIB) or large IB (defined as size ≥4 cm).
Tissue available for the required analyses
No prior treatment with agents targeting EGFR mutation, ALK rearrangement, and PD1/PD-L1/CTLA-4.
BCC022: Phase II Trial of Tipifarnib and Naxitamab for Relapsed/Refractory Neuroblastoma
The purpose of this research is to evaluate the investigational drug, tipifarnib (a pill taken by mouth), in combination with the FDA approved drug, naxitamab, administered intravenously (IV; a liquid that continuously goes into your body through a tube that has been placed during a surgery into one of your veins).
You will be asked to come in for screening and at the start of each cycle (every 28 days), and at the end of study treatment to have tests done (these may include a physical exam, blood tests, and electrocardiogram [ECG]). During the first cycle you will need to have blood tests done weekly. You will also need to come in during Days 1-5 of each cycle to receive the study treatment. You will also have scans and a bone marrow biopsy (tissue sample) and aspirate (fluid and cells) done at the start of study, every 2 cycles, and at the end of study.
Age >12 months of age at enrollment
Age 6 years or older for safety run in
Currently receiving another investigational drug
PSCI 21-190 A randomized study of the efficacy of Daromun Neoadjuvant treatment followed by surgery
The purpose of this study is to test the efficacy of Daromun neoadjuvant treatment followed by surgery and adjuvant therapy to improve in a statistically significant manner the recurrence-free survival (RFS) of Stage IIIB/C melanoma patients with respect to the standard of care (surgery and adjuvant therapy)
Arm 1, 19 in person visits, blood drawn at each visit Arm 2, 14 in person visits, blood drawn at each visit
Eligible subjects must have measurable disease and must be candidate for intralesional therapy with at least one injectable cutaneous, subcutaneous, or nodal melanoma lesion
Males or females, age ≥ 18 years
ECOG Performance Status/WHO Performance Status ≤ 1.
Life expectancy of > 24 months
Evidence of distant metastases at screening
Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ
Presence of active infections
History within the last year of acute or subacute coronary syndromes including myocardial infarction, unstable or severe stable angina pectoris
PSCI 23-002 CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment for Patients with ER+/HER2-Early Breast Cancer and an Intermediate-High or High Risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No Evidence of Disease
We are asking you to take part in this voluntary research study because you have ER+/HER2- early breast cancer with no evidence of disease following surgery. The purpose of this voluntary research study is to better understand the studied disease and associated health problems.
Participants will be required to come to all study visits, take the medication an instructed, let the study team know what medications you are taking, especially over the counter ones and to report any changes in how you are feeling.
Patient must be ≥18 years
histologically confirmed ER+/HER2- early-stage resected invasive breast cancer
a history of previous breast cancer
Chronic gastrointestinal disease
Major surgical procedure or significant traumatic injury within 2 weeks of randomisation
PSCI# 24-014 OPTIMICE-PCR: DE-ESCALATION OF THERAPY IN EARLY-STAGE TNBC PATIENTS WHO ACHIEVE PCR AFTER NEOADJUVANT CHEMOTHERAPY WITH CHECKPOINT INHIBITOR THERAPY
this trial is examining what happens if a less toxic therapy is given to triple negative breast cancer subjects who's tumor is completely gone after receiving pre surgery chemotherapy.
Participants will need to come to all research visits, reports any side effects of medication, if they are taking any over the counter medications.
ECOG Performance Status 0-2
Triple Negative Breast Cancer
Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles. All systemic chemotherapy must have been completed preoperatively.
An interval of no more than 12 weeks between the completion date of the final surgery and the date of randomization.
No history of any prior (ipsi- or contralateral) invasive breast cancer. Prior DCIS is allowed.
No evidence of recurrent disease following preoperative therapy and surgery.
No known active liver disease, e.g. due to HBV, HCV, autoimmune hepatic disorders, or sclerosing cholangitis
PSCI #24-126 A Phase III Trial Of Perioperative Versus Adjuvant Chemotherapy For Resectable Pancreatic Cancer.
This study is for subjects who have removable pancreatic cancer. If subjects decide to take part in this study, subjects will either get the study drugs FOLFIRINOX for about 4 months followed by surgery and then more FOLFIRINOX for about 2 months, or subjects will get surgery followed by FOLFIRINOX for about 6 months. After subjects finish their treatment, the subject's doctor will continue to watch them for side effects. They will check subjects in the clinic every 4 months for 2 years after you started the study. After that, they will check subjects either in the clinic or by phone every 6 months for 6 years after the subject started the study. This means that the subject will keep seeing or hearing from their doctor for 6 years after they started the study.
Subject will either get the study drugs FOLFIRINOX for about 4 months followed by surgery and then more FOLFIRINOX for about 2 months, or the subjects will get surgery followed by FOLFIRINOX for about 6 months. After treatment the doctor will continue to watch for side effects. They will check on the subjects in the clinic every 4 months for 2 years after the subject started the study. After that, they will check the subject either in the clinic or by phone every 6 months for 6 years after you started the study. This means that the subject will keep seeing or hearing from your doctor for 6 years after you started the study.
No evidence of metastatic disease
Less than 180° interface between tumor and vessel wall of the portal vein or superior mesenteric vein, and patent portal vein/splenic vein confluence
No involvement or abutment of the celiac artery, common hepatic artery, superior mesenteric artery, or replaced right hepatic artery (if applicable)
Age ≥ 18 years
comorbid conditions that would prohibit curative-intent pancreatectomy
ECOG Performance Status greater than 0-1
EA8183 A Phase III Study of Early Intervention after RADICAl ProstaTEctomy with Androgen Deprivation Therapy with Darolutamide vs. Placebo in Men at Highest Risk of Prostate Cancer Metastasis by Genomic Stratification (ERADICATE) (PSCI# 21-122)
This study is being done to answer the following question: Will the addition of a new drug, darolutamide, to standard Androgen Deprivation Therapy (ADT) (a hormonal therapy that is a usual approach to treatment) after surgery cure more men with prostate cancer than using Androgen Deprivation Therapy alone? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your prostate cancer. The usual approach is defined as care most people get for prostate cancer.
This study is being done to answer the following question: Will the addition of a new drug, darolutamide, to standard Androgen Deprivation Therapy (ADT) (a hormonal therapy that is a usual approach to treatment) after surgery cure more men with prostate cancer than using Androgen Deprivation Therapy alone? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your prostate cancer. The usual approach is defined as care most people get for prostate cancer.
Patient must have undergone a radical prostatectomy (RP) and must be preregistered to Step 0 of this study at least 6 weeks after but not more than 12 weeks after their radical prostatectomy.
Patient must not have any previous treatment with androgen deprivation therapy (ADT), chemotherapy, or other physician prescribed systemic therapy for treatment of their prostate cancer.
Patient must have an ECOG performance status of 0-2.
Patient must not have an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Class III and IV heart failure).
PSCI 24-114: A Phase II Study Of Tailored Adjuvant Therapy In Pole-Mutated And P53- Wildtype/NSMP Early-Stage Endometrial Cancer (Rainbow Blue & Taper)
This study is to find out if there are types of early-stage endometrial cancer that require less treatment than the usual approach. Based on laboratory testing of the cancer and the extent of spread at time of surgery. The study doctor may recommend Sub-study A or Sub-study B. Based on this assessment, subjects may receive no therapy (observation) or less therapy (de-escalated therapy) than the subject would have received as part of your usual treatment.
Treatment that will be recommended to the subject will be based on laboratory testing of the cancer and the extent of spread at time of surgery. The study doctor might recommend that the subject participate in Sub-study A or Sub-study B. Based on this assessment, the subject may receive no therapy (observation) or less therapy (de-escalated therapy) than the subject would have received as part of their usual treatment After the subject finishes study treatment, and even if they stop treatment early, the study doctor will continue to follow the subject's condition, watch the subject for side effects and keep track of the subjects health. The subject will be seen after 3 months and 6 months, then every 6 months for 3 years, and then every year after starting the study until the study closes. The subject may be seen more often if subject's study doctor thinks it is necessary.
Patients’ Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2.
Patients’ age must be greater than18 years.
Patients must have had surgery consisting of hysterectomy (total abdominal, laparoscopic or robotic-assisted) and bilateral salpingo-oophorectomy. Lymph node dissection can be performed as per institutional standards (sentinel or full lymphadenectomy)
HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
Prior pelvic radiation.
Clinical evidence of distant metastasis as determined by pre-surgical or post-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CT scan)
Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumours curatively treated with no evidence of disease for ≥ 5 years.
A Phase 3 RandOmized Study Comparing PERioperative Nivolumab Vs. Observation in Patients with Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC) (EA8143) (PSCI 18-025)
This study is a phase 3 study that will be comparing recurrence-free survival (RFS) between patients with locally advanced renal cell carcinoma randomly assigned to perioperative nivolumab in conjunction with radical or partial nephrectomy with patients randomized to surgery alone.
You are being asked to take part in this research study because you have cancer in your kidney, which is planned to be removed by a surgeon. The standard treatment for your disease is to remove the kidney or part of the kidney that contains the cancer by surgery. You are then monitored after surgery with imaging scans and exams to watch for any possible signs of recurrence (close observation)
No clinical or radiological evidence of distant metastases
No concurrent or prior systemic or local anti-cancer therapy for RCC is permitted
Age must be greater than or equal to 18 years old
ECOG Performance status must be 0 or 1
History of RCC that was resected with curative intent within the past 5 years
Prior or current prostate cancer is excluded
Active known or suspected autoimmune disease
Uncontrolled adrenal insufficiency
PSCI 22-156 HCRN BRE17-141
The purpose of this voluntary research study is to see if neratinib, endocrine therapy, and trastuzumab completely shrink breast tumors before having breast cancer surgery. You will need to have the following exams, tests, or procedures: blood draws, ECG, Echo or MUGA, ultrasound, MRI, receive study treatment, and breast biopsy.
Participants will be required to receive study treatments, laboratory assessments, undergo breast biopsy, and radiologic assessments,
HER2-positive (by most recent ASCO-CAP criteria)
ER > 50% and PR > 50%.
Resectable breast cancer in which pre-operative therapy is appropriate (T > 10mm and/or node-positive).
Archival tissue from the diagnostic pre-treatment biopsy is required.
Evidence of metastatic disease.
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial:
Active infection requiring systemic therapy.
Requirement for use of a moderate or strong CYP3A4 inhibitor or inducer during the study
CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts: A Prospective, Randomized, Double-blind, Multi-center Clinical Trial
This study seeks to verify the findings of the CHARM I pilot study by conducting a multi-center clinical trial. We hypothesize that: • Pancreatic cyst infusion with a specifically designed drug therapy cocktail following normal saline lavage will result in cyst destruction rates that do not significantly differ from those achieved by alcohol-based cyst treatment (ethanol lavage followed by infusion of the same chemotherapeutic cocktail). • The removal of alcohol from the procedure will decrease both serious and minor adverse event rates associated with pancreatic cyst treatment. • There may be molecular markers contained within the fluid of these cystic tumors which identify cysts that are favorable to or resistant to EUS-guided fine needle infusion using this drug combination. As such, we will test all treated cysts for 10 of the best known molecular markers for evaluation in post study analysis. We expect that administering a specifically designed chemotherapeutic cocktail without prior alcohol lavage will result in an equivalent rate of cyst resolution with fewer complications when compared to alcohol. The results of this study will provide important information about the most efficient and safest method for treating premalignant pancreatic cysts, an important step for treating these lesions with a minimally invasive technique and preventing their progression to cancer. Standard alternative treatment options for this patient group (if not taking part in this study) would be ongoing periodic radiographic monitoring with MR or CT imaging waiting for signs of cancer to develop or to consider surgical removal of the affected tissue.
Patients will have to sign the consent form to participate in the trial
Patients with a previously-detected pancreatic cyst(s) 2-5 cm in diameter which are consistent with a mucinous type cyst as per ASGE guidelines including indeterminate type cysts.
Ability to give written informed consent.
Capable of safely undergoing endoscopy with deep sedation or general anesthesia.
Known or suspected pancreatic cancer or pathologic lymphadenopathy.
Cysts with the following high risk features: main pancreatic duct dilation of > 5mm,epithelial type mural nodules , pathologically thick wall/septation (> 2mm)..
Septated cysts with > 4 compartments.
Confirmed acute pancreatitis within the last 3 months.
A Phase 3, Randomized Study of Adjuvant Cretostimogene Grenadenorepvec versus Observation for the Treatment of Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR-NMIBC) Following Transurethral Resection of Bladder Tumor (TURBT)
Participants in the PIVOT-006 study will either receive surgical treatment plus cretostimogene or surgical treatment alone.This is a Phase 3, open-label, randomized trial designed to evaluate the RFS of TURBT followed by CG0070 vs TURBT for the treatment of patients with IR-NMIBC.The purpose of this study is to see if cretostimogene can reduce the risk of your bladder cancer returning, or coming back as quickly as if you did not receive cretostimogene. People in the study will continue to be monitored by cystoscopy and pathology to see how long it takes for the cancer to return. Who May Be Eligible to Take Part In This Study: People with: • Bladder Cancer that has not invaded the muscle (Non-Muscle Invasive Bladder Cancer) • Intermediate-Risk Disease • Over 18All Treatment: 18All patients will receive surgical treatment on study as part of Standard-of-Care. 50% of patients will receive cretostimogene in addition to surgical treatment. For patients who do not receive cretostimogene, you will be offered cretostimogene if your bladder cancer recurs. The treatment will be instilled into the bladder through a thin tube called a catheter. This will be done 14 times over an 12-month period. Main Meausure: Patients who have recurrence of bladder cancer after receiving surgery plus cretostimogene compared to patients who receive surgery alone.
if you decide to take part in this study and meet all of the requirements, all patients will receive surgical treatment on study as part of Standard-of-Care. 50% of patients will receive cretostimogene in addition to surgical treatment. For patients who do not receive cretostimogene, you will be offered cretostimogene if your bladder cancer recurs. You will receive 6 treatments, once per week for 6 weeks in a row. The treatment will be instilled into the bladder through a thin tube called a catheter. This will be done 14 times over an 12-month period. There will be up to 16 visits with blood draw and/or urine colelction. As a part of screening, efficacy and follow up for this study, you might have to have cystoscopy ( up to 6), urine cytology (up to 6), TUBRT or vladder mapping or CT urogram over a 3 year month period.
Intermediate-Risk Disease
Is ≥18 years of age on day of signing informed consent.
Demonstrates adequate organ function
Is willing to comply with study mandated cystoscopies, urine cytology, CT urograms, TURBTs/biopsies, and other procedures
Has disease that cannot be completely resected.
Has current or history of muscle-invasive cancer or locally advanced or metastatic bladder cancer
Has a history of High-grade or Low-Grade urothelial cancer
Has received systemic anti-cancer therapy, including investigational agents, within 4 weeks of randomization.
GLNE 007 Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas
The purpose of this study is to see if stool or blood can be used to determine whether or not a patient has any colon polyps or colon cancer. This study will compare these biological samples (blood, urine, stool) to any colonoscopy or surgery a patient has to see if the outcome could be predicted.
Subjects with Colon Cancer or Adenoma
OR subjects undergoing colonoscopy screening
HIV/Hepatitis
Have had or are receiving chemotherapy or radiation
Have had surgery for your colon cancer
Cognitive Impairment
PSCI 24-040 A NON-RANDOMIZED PROSPECTIVE CLINICAL TRIAL COMPARING THE NON-INFERIORITY OF SALPINGECTOMY TO SALPINGO-OOPHORECTOMY TO REDUCE THE RISK OF OVARIAN CANCER AMONG BRCA1 CARRIERS [SOROCk]
This protocol is comparing two types of surgery, one with the removal of the ovaries, fallopian tubes and uterus against removal of the fallopian tubes and uterus in subjects how are between 35 and 50 with the BRCA1 mutation..
Participants must be carriers of the BRCA1 gene mutation. This trial involves going to the operating room to have either their fallopian tubes removed or their ovaries and fallopian tubes removed. A vaginal ultrasound will be done. you will have blood drawn and a pregnancy test done. This will happen before surgery.
At least one intact ovary and fallopian tube
Positive CLIA-approved test results for pathogenic or likely pathogenic germline BRCA1 mutation in the patient.
Patients may be premenopausal or menopausal.
Transvaginal ultrasound (TVUS) and CA-125 within 180 days of registration.
Prior history of ovarian cancer,
Patients medically unfit for the planned surgical procedure.
Patients with abnormal screening tests
PSCI 22-127 NRG_BN012
Individuals with cancer that has spread to their brain who have 1-4 lesions, or breast cancer history and may or may not have treatment and are within 8 weeks of surgery, will be randomized to either surgery first followed by radiation or radiation first followed by surgery.
Subjects are expected to come to all Radiation/Gamma Knife appointments and continue onto surgery/resection.
Known active or history of invasive non-CNSprimary cancer based on documented pathologic diagnosis within the past 3 years.
All brain metastases must be located ≥ 5 mm from the optic chiasm and outside the brainstem.
Lesions chosen for surgical therapy must be deemed appropriate targets for safe, gross total resection by the treating surgeon
Age ≥ 18
Evidence of leptomeningeal disease
Primary histology of germ cell tumor, small cell carcinoma or lymphoma
Inability to undergo MRI with contrast.
More than one brain metastasis planned for resection
A Randomized Phase II Trial of Adjuvant Pembrolizumab versus Observation Following Curative Resection for Stage I Non-small Cell Lung Cancer (NSCLC) with Primary Tumors Between 1-4 cm:Big Ten Cancer Research Consortium BTCRC-LUN18-153 (PSCI# 20-043)
This is a research study to find out if giving a drug called pembrolizumab after lung cancer surgery does a better job at keeping the cancer from coming back than surgery alone. The usual approach for patients who are not in a study is to be followed closely by their doctor to watch in case the cancer returns. Participants in this study will be assigned by chance (flip of a coin) to be watched closely by their doctor or to receive a drug called pembrolizumab. Pembrolizumab is given as an infusion in the clinic once every six weeks. . You will have tests, exams and procedures that are part of your regular care and for study purposes. You will have scans every 12 weeks to make sure the cancer hasn’t come back. If you are assigned to receive pembrolizumab, you can continue to receive it for up to 1 year.
If you decide to take part in this study, you will be assigned to one of two groups. This is called randomization. A computer will assign you to a group in the study by chance. This is done by chance because no one knows if one study group is better or worse than the other. You will have an equal chance (50/50) of being assigned to either group.
Patients must have undergone complete surgical resection of their stage I non-small cell lung cancer between 4-12 weeks prior to registration.
Pathological tumor size must be 1.0 – 4.0 cm in size.
ECOG Performance Score 0-1
Baseline CT chest must be performed within 28 days of randomization
No prior PD-1 or PD-L1 inhibitors are permitted.
No prior neo-adjuvant or adjuvant chemotherapy is permitted for this lung cancer.
Patients with a history of (non-infectious) pneumonitis that required steroids
Has active autoimmune disease that has required systemic treatment in the past 2 years.
PSCI# 24-028 NRG-BR008: A PHASE III RANDOMIZED TRIAL OF RADIOTHERAPY OPTIMIZATION FOR LOW-RISK HER2-POSITIVE BREAST CANCER (HERO*)
This study will look at the differences in recurrence between patients who receive breast radiation after surgery to those who don't.
Participants will be required to come to all study visits, complete their radiation and chemotherapy treatments.
The patient must have an ECOG performance status of 0 ,1,
Histologically or cytologically confirmed invasive breast carcinoma.
The tumor must have been determined to be HER2-positive by current ASCO/CAP guidelines based on local testing results.
The tumor must have ER and PgR status assessed locally using current ASCO/CAP Guidelines.
patients with a primary tumor >2 cm on pathologic examination of the surgical specimen
Patient planning for or status-post mastectomy.
Non-epithelial breast malignancies such as sarcoma or lymphoma.
Multicentric carcinoma (invasive cancer or DCIS)
PSCI 23-092 EA8192 A Phase II/III trial of Durvalumab and Chemotherapy for Patients with High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy
This trial is comparing outcomes of cisplatin eligible vs cisplatin ineligible high grade urothelial cancer patients treated with accelerated therapy vs gemcitabine and durvalumab followed by surgery.
Participants will need to complete all study visits, agree to having surgery and to make sure to tell the study team if they are having any side effects.
Patient must have the ability to understand and the willingness to sign a written informed consent document
Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy
Patients must not have any component of small cell/neuroendocrine carcinoma
Patients must not be pregnant or breast-feeding
Patient must not have another active (or within two years) second malignancy
Patient may have a history of resectable urothelial cancer
Patient must not have any uncontrolled illness
Patient must not have received prior systemic anthracycline therapy
20-099, EA1181 (CompassHER2-pCR): Preoperative THP and postoperative HP in patients who achieve a pathologic complete response
The purpose of this study is to test whether it is safe to eliminate additional chemotherapy after surgery in patients with HER2-positive breast cancer who have no remaining cancer at surgery, after receiving a single chemotherapy drug (for most patients, paclitaxel), with Herceptin (trastuzumab) and Perjeta (pertuzumab) for 12 weeks before surgery. The standard treatment for patients who have no remaining cancer at surgery is to receive additional chemotherapy after surgery. This study will test whether patients who receive no further chemotherapy after surgery have no higher chance of tumor recurrence than patients who have received additional chemotherapy after surgery.
The purpose of this study is to test whether it is safe to eliminate additional chemotherapy after surgery in patients with HER2-positive breast cancer who have no remaining cancer at surgery, after receiving a single chemotherapy drug (for most patients, paclitaxel), with Herceptin (trastuzumab) and Perjeta (pertuzumab) for 12 weeks before surgery. The standard treatment for patients who have no remaining cancer at surgery is to receive additional chemotherapy after surgery. This study will test whether patients who receive no further chemotherapy after surgery have no higher chance of tumor recurrence than patients who have received additional chemotherapy after surgery.
Patents must have a left ventricular ejection fraction (LVEF) within normal institutional parameters (or > 50%).
Patient must not have Stage IV (metastatic) breast cancer
Patient must not have T4 and/or N3 disease, including inflammatory breast cancer.
Patient must not have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy.
Patient must not have a concurrent serious medical condition that would preclude completion of study therapy.
ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer (ENLIGHTED)
Upper tract urothelial cancer (UTUC) is a recurrent disease. The current standard treatment for most UTUC patients requires surgery either removing some of the ureter in each operation or radical nephroureterectomy (RNU-removal of kidney and ureter) but the role of minimally invasive & kidney- preserving methods is increasing. The use of TOOKAD (padeliporfin) was investigated in a Phase 1 clinical study in the minimally-invasive treatment of UTUC with the goal of identifying safe laser/light exposure and signs that the tumor has been reduced or eliminated. Early results from this study have been highly promising, revealing the effects of tumor removal with a positive safety profile, indicating the potential role of TOOKAD (padeliporfin) in the treatment of low-grade UTUC disease. This Phase 3 study is designed to provide confirmation of the observed Phase 1 findings. Patients are expected to remain in the study for 25 to 28 months. Participation in this study will include up to 9 study visits to Hershey Medical Center and 2 phone visits.
There are 4 stages to this study: screening phase, induction study treatment phase, maintenance study treatment phase and long-term follow-up phase. In screening you can expect to be asked questions about your medical history, MRI or CTU, blood and urine samples, physical exam, vitals, tumor assessment by ureteroscopy and biopsy under anesthesia. Induction Treatment Phase (1-3 months) • Participants undergo anesthesia and receive the study therapy 1 to 3 times, about 4 weeks apart. If a participant does not achieve Complete Response (CR)* after 3 treatments (or if their disease has progressed as defined in the protocol), the participant will be discontinued from the Treatment Phases and enter the Long-term Follow-up Phase. Maintenance Treatment Phase (12 months) • Participants who achieve CR* from Induction Treatment Phase will be followed for 12 months. Up to 3 repeated study therapy doses will be provided for participants who have treatable tumor recurrence as determined by the study doctor. Long-term Follow-up Phase (48 months) • Patients who achieve CR and then enter the maintenance treatment phase and who have a CR after the end of maintenance treatment phase will enter the Long-term Follow-up Phase and will be followed up for up to an additional 48 months in the Long-term Follow-up Phase or until recurrence, progression, death or loss to follow up, to document safety and ongoing response. • Patients discontinued from the treatment phases and who have received at least one study treatment will be followed up for additional 12 months in the long-term follow-up phase of the study from last VTP treatment.
Biopsy-proven disease. A concurrence of the central pathology reader will be required for eligibility.
Up to 2 biopsy-proven sites of low-grade involvement. Please contact site for tumor dimension criteria.
Karnofsky Performance Status ≥ 50%
Adequate organ function defined by baseline Lab testing
Carcinoma in situ (CIS) current or previous in the upper urinary tract
History of invasive T2 or higher urothelial cancer in past 2 years
Participation in another clinical study involving an investigational product within 1 month before study entry
BCG or local chemotherapy treatment in the upper urinary tract within 2 months prior to inclusion
A Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab versus Placebo after Surgery and Radiation Therapy in Patients with High Risk Cutaneous Squamous Cell Carcinoma (CSCC) (PSCI 18-112)
This study is a comparison of disease-free survival of patients with high-risk cutaneous squamous cell carcinoma (CSCC) when treated with a medication (cemiplimab) versus those treated with placebo after already having surgery and radiation therapy.
The study is conducted in 2 parts. Part 1 consists of a screening period, treatment period and a completion period including a period of long term follow up. During part 1, you will be asked to answer questions about your health, participate in a physical examination that includes vital signs, height and weight, have testing done including an electrocardiogram, blood draws, urine sampling, pregnancy test, biopsy, and medical imaging. Part 2 consists of an additional screening period, treatment period and an end of treatment period.
70.00 per visit
Post resection and curative intent post-operative Radiation Therapy within 2 to 6 weeks of randomization
Adequate hepatic, renal, and bone marrow function as defined in the protocol
Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol
Significant autoimmune disease that required treatment with systemic immunosuppressive treatments (including corticosteroids)
Has had prior systemic anti-cancer immunotherapy for cutaneous squamous cell carcinoma
SARS Cov-2 Nasal Pharyngeal and Oral Pharyngeal Wash (SNOW) Trial SARS Cov-2 Nasal Pharyngeal and Oral Pharyngeal Wash (SNOW) Trial
Adults recently diagnosed with SARS-CoV-2 infection who use a 4-day combined intervention of nasal washes with 1% baby shampoo solution and oral gargles with Listerine Antiseptic® will have a reduced SARS-CoV-2 viral load compared to those using nasal and oral washes with normal saline. This combined intervention should be acceptable, tolerable and safe in this population. To test this, we are conducting a trial comparing the efficacy of a number of washes in reducing the oral and nasal SARS-CoV-2 viral load amongst adults.
At their home, participants will perform three nasal and oral rinses per day for 4 days and self-swab the nose and mouth before and after each morning rinse to collect specimens under the guidance of a zoom visit. On the morning of the 5th day participants will also self swab the nose and mouth for a final collection specimen. Participants will answer questions on an app and online platform.
100
A positive test for SARS-CoV-2 infection within 5 days of enrollment
Currently in isolation
Non-English speaking
Lack of electronic device (computer, mobile phone etc) on which to access an app for study data collection
Adults that need inpatient care for COVID-19 or any of its complications
Adults that give a history of being unable to tolerate gargles or nasal washes
PSCI# 25-018 Randomized Phase III Trial of Neoadjuvant Immunotherapy with Response-Adapted Treatment Versus Standard of Care Treatment for Resectable State II/IV Cutaneous Squamous Cell Carcinoma
This study is comparing standard of care surgery and after surgery radiation against pre-surgery immunotherapy, followed by surgery, followed by radiation and immunotherapy to determine which combination prevents cancer reoccurrence.
Participants must come to all scheduled study visits, all medications they are taking including over the counter and tell the study doctor how you are feeling. 7 visits; 3 blood draws; QOLs to be completed 5 times for Group 1 and 7 times for Group 2
Previously untreated or recurrent CSCC
Age ≥ 18
ECOG Performance Status of 0-2
Not Pregnant and Not Nursing
No active infection requiring systemic antibiotics, antiviral, or antifungal treatments
No history of allogeneic stem cell transplantation, or autologous stem cell transplantation.
No prior systemic therapy for the study cancer
A Multicenter Observational Study of GammaTile™ Surgically Targeted Radiation Therapy (STaRT) in Intracranial Brain Neoplasms
This study is for participants who have a brain tumor and decide with their doctor to use GammaTile radiation therapy to treat their brain tumor. This treatment is FDA approved. The purpose of this study is to collect data on how this treatment impacts your health and wellbeing.
There are no required visits or treatments for this study. At your regularly scheduled doctor visits, your study doctor or staff will enter relevant health and medical information into the study database. You will also be asked to complete questionnaires about the quality of your life during your routine medical appointments.
Willing and able to provide informed consent and to participate in all evaluations.
Major medical or psychiatric illness, which, in the investigator’s opinion would prevent completion of treatment, ability to complete assessments at the time of enrollment, and/or interfere with follow ups.
Lack of English or Spanish language fluency sufficient to allow for providing informed consent and for completion of QOL tests all of which are available in English and Spanish.
A PHASE 3 RANDOMIZED STUDY OF INTRALESIONAL CEMIPLIMAB VERSUS PRIM ARY SURGERY IN PARTICIPANTS WITH EARLY STAGE CUTANEOUS SQUAMOUS CELL CARCINOMA (CSCC)
The purpose of this study is to measure Event Free Survival (EFS) with IL cemiplimab (investigational intervention) compared with primary surgery for participants who have an eligible CSCC (cutaneous squamous cell carcinoma) that is great than or equal to 1 to less than or equal to 2 cm in the longest diameter. The maximum length that a participant will be on study is approximately 3 years. Participants will be assigned 2 to 1 to either the experimental arm or the control arm.
The maximum length that a participant will be on study is approximately 3 years. Visit Frequency: - Experimental Arm: Every week for 6 treatment visits. There is a clinical visit for TL assessment on Week 8. Assessment of response at the TL site occurs at week 13. -Control Arm: 1 day for surgery, with post-surgical visits at week 3 and week 13 -Both Arms: Week 19, then every 3 months for years 1 and 2, and every 4 months for year 3. Additional visits may occur for clinical issues that may arise, per standard of care. At different timepoints throughout the study participants will have their skin examined and photographed, answers questionnaires/interview, have blood drawn, and have a biopsy.
Willing and able to comply with clinic visits and study-related procedures.
Labs will be drawn; must have adequate hepatic function, renal function, and bone arrow function.
Must be willing to understand and comply with the study requirements
Certain medications are allowed at a maximum stable dose, study coordinator will discuss further
Certain medical history conditions are excluded from participation; study coordinator will discuss
AOST2031: A Phase 3 Randomized Controlled Trial Comparing Open vs Thoracoscopic Management of Pulmonary Metastases in Patients with Osteosarcoma
The overall goal of this study is to compare the effects, good and/or bad, of two different surgery methods for people with OST that has spread to the lung to find out which is better. In this study, participants will receive 1 of 2 treatment plans. Treatment with open surgery is the older standard therapy for people with OST that has spread to the lung. Treatment with VATS is a newer method that has also been shown to work when used to treat the same type of cancer
Consent to treatment, required labs, sample collections, and completion of research study tests and surveys and/or questionnaires.
Patients must have ≤ 4 nodules per lung consistent with or suspicious for metastases, with at least one of which being ≥ 3 mm and all of which must be ≤ 3 cm size
Lung nodules must be considered resectable by either open thoracotomy or thoracoscopic surgery. Determination of resectability is made by the institutional surgeon
Patients must have a histological diagnosis of osteosarcoma
Patients must have evidence of metastatic lung disease at the time of initial diagnosis, or at time of 1st recurrence following completion of therapy for initially localized disease.
Patients with chest wall or mediastinal based metastatic lesions, or with significant pleural effusion.
Patients with evidence of extrapulmonary metastatic disease
Patients who received therapeutic pulmonary surgery for lung metastasis prior to enrollment
Patients with disease progression at either the primary or pulmonary metastatic site while on initial therapy. N
AHEP1531 - Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT)
This partially randomized phase II/III trial studies how well cisplatin and combination chemotherapy works in treating children and young adults with hepatoblastoma or liver cancer after surgery. Drugs used in chemotherapy, such as cisplatin, doxorubicin, fluorouracil, vincristine sulfate, carboplatin, etoposide, irinotecan, sorafenib, gemcitabine and oxaliplatin, 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. Giving combination chemotherapy after surgery may kill more tumor cells.
Consent to treatment, required labs, sample collections, and completion of research study tests.
Patients in Group F must have a BSA ≥ 0.6 m2 .
Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age.
Patients newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma
Patients who are currently receiving another investigational drug
Patients who are currently receiving other anticancer agents
Patients with uncontrolled infection.
Patients who previously received a solid organ transplant, other than those who previously received an orthotopic liver transplantation (OLT) as primary treatment of their hepatocellular carcinoma.
PSCI 23-146 A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery
this trial will compare Pembrolizumab with and without MK-2870 in participants with lung cancer for disease free survival.
Participants will be required to com to all study visits, report all medications they are taking, including over the counter medications and tell the study team how they are feeling.
$50 for each completed visit
Able to undergo surgery based on opinion of investigator after consultation with surgeon.
Able to receive pembrolizumab and platinum-based chemotherapy
Has not achieved pathologic Complete Response at surgery
18 years of age
Has history of documented severe dry eye syndrome,
Has active inflammatory bowel disease
Has active inflammatory bowel disease