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179 Clinical Paid Trials near Tennessee
Power is an online platform that helps thousands of patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerAPRETUDE for HIV Prevention
Memphis, Tennessee
The purpose of the study is to evaluate the appropriateness, adoption, feasibility, fidelity, and acceptability of implementation strategies and Cabotegravir (CAB) pre-exposure prophylaxis (PrEP). The study objectives are also to identify barriers and facilitators to implementation. The first of two participant types in the study are the Patient Study Participants (PSPs) will refer to individuals who are enrolled in the study and who will receive commercially available CAB PrEP via prescription from the PrEP provider. The second are Staff Study Participants (SSPs) who are site staff involved in the administrative and clinical aspects of offering and administering PrEP to PSPs at the clinical site.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Sex:Female
Key Eligibility Criteria
Disqualifiers:HIV Positive, Male, Others
Must Be Taking:PrEP
66 Participants Needed
Pimavanserin PET Tracer for Neurodegenerative Disease
Nashville, Tennessee
This trial tests if pimavanserin can help improve psychosis symptoms in Parkinson's Disease patients by affecting specific brain receptors. Pimavanserin is an atypical antipsychotic approved for treating hallucinations and delusions in Parkinson's disease psychosis. The study uses brain scans to measure changes over time.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:50 - 85
Key Eligibility Criteria
Disqualifiers:Stroke, Neurological Illness, Pregnancy, Others
Must Not Be Taking:Serotonergics, Antipsychotics, Pimavanserin
75 Participants Needed
Atorvastatin for Preventing Dementia
Nashville, Tennessee
PREVENTABLE is a multi-center, randomized, parallel group, placebo-controlled superiority study. Participants will be randomized 1:1 to atorvastatin 40 mg or placebo. This large study conducted in community-dwelling older adults without cardiovascular disease (CVD) or dementia will demonstrate the benefit of statins for reducing the primary composite of death, dementia, and persistent disability and secondary composites including mild cognitive impairment (MCI) and cardiovascular events.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:75+
Key Eligibility Criteria
Disqualifiers:Cardiovascular Disease, Dementia, ADL Dependence, Others
Must Not Be Taking:Statins
20000 Participants Needed
Megestrol for Feeding Disorders in Children
Nashville, Tennessee
This is a multi-center, randomized, placebo-controlled, double-blind clinical trial. The primary focus of the study is the evaluation of the effectiveness of treatment with megestrol as part of a 24 week behavioral feeding protocol in transitioning from tube to oral feedings in a pediatric population. Approximately 60 pediatric subjects matching the criteria for eligibility will be enrolled in the study and randomized to receive either megestrol (n=30) or placebo (n=30).
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:9+
Key Eligibility Criteria
Disqualifiers:Not Listed
71 Participants Needed
Cenegermin for Neurotrophic Keratopathy
Nashville, Tennessee
TITLE: Toyos Clinic / A Phase 4 Study to Assess Longer Duration of Treatment with Cenegermin in Moderate to Severe Dry Eye-Associated Neurotrophic Keratitis
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Severe Allergy, Active Infection, Pregnancy, Others
Must Not Be Taking:Topical Glaucoma, Eyelash Growth
10 Participants Needed
Personalized Opiate Therapy for Post-Surgical Pain
Knoxville, Tennessee
The main questions this study aims to answer are:
Does perioperative PGx personalized opiate therapy reduce persistent post-operative opioid use dependency, improve pain management and reduce opiate related adverse events in opioid naïve patients after surgery?
Participants will:
Take hydromorphone if the PGx results determine they have a SNP indicating high or low metabolic activity in the CYP2D6 enzyme.
Complete a 7-day pain diary post-discharge. Complete a follow-up phone call once per month for 90 days.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Cognitive Impairment, Recent Surgery, Allergies, Others
208 Participants Needed
RSV Vaccination + Immunization for Respiratory Syncytial Virus
Nashville, Tennessee
Respiratory Syncytial Virus (RSV) is the leading cause of lower respiratory tract infections (LRTIs) in infants and young children. It is also a leading cause of mortality in children \<5 years of age worldwide. Until recently, no Food and Drug Administration (FDA)-approved vaccines were available to prevent RSV infection. The only prophylactic product for RSV prevention recommended for infants was the monoclonal antibody palivizumab, but administration was limited to those with extreme prematurity, chronic lung disease, or hemodynamically significant congenital heart disease. However, in 2023, the FDA approved two products designed to prevent RSV lower respiratory tract disease (LRTD) in all infants: an active RSV vaccine based on the prefusion F protein (RSVpreF, ABRYSVO, Pfizer) administered during pregnancy, and a passive, long-acting monoclonal antibody (nirsevimab-alip \[henceforth referred to as nirsevimab\], BEYFORTUS, AstraZeneca) administered to infants at birth or at the start of their first RSV season. Both products were evaluated in Phase 3 pivotal clinical trials and have high efficacy in preventing LRTD caused by RSV in infants. Although there is no established correlate of protection against RSV, antibodies have been associated with protection across multiple studies. The clinical development plan for the products did not include comprehensive evaluations of the magnitude and durability of the immune response, nor were the two products tested in a single trial. This study is a prospective, randomized, open-label Phase 4 study with the primary objective of evaluating the magnitude and durability of RSV-specific neutralizing antibodies in infants through 12 months of life following either maternal RSV vaccination, infant nirsevimab administration, or both products combined.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:18 - 45
Sex:Female
Key Eligibility Criteria
Disqualifiers:Psychiatric Disease, Immune Impairment, Others
Must Not Be Taking:Immunosuppressants, Corticosteroids
400 Participants Needed
Ofatumumab for Early Relapsing-Remitting Multiple Sclerosis
Knoxville, Tennessee
This study will evaluate the impact of ofatumumab in Relapsing Remitting Multiple Sclerosis (RRMS) participants that are very early in the course of their disease using clinical and magnetic resonance imaging (MRI) outcomes. The study will also assess changes in disease using monitoring techniques including digital biometric device use, biomarker analysis and non-conventional MRI. Select outcomes in the ofatumumab treated group will be compared to a group of Healthy participants to determine if there are similarities between the groups after the patients with MS undergo treatment with ofatumumab.
No Placebo Group
Prior Safety Data
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:18 - 35
Key Eligibility Criteria
Disqualifiers:Neuromyelitis Optica, Active Infections, Others
Must Not Be Taking:Experimental Drugs, Chemotherapy
180 Participants Needed
Risperidone vs Aripiprazole for Weight Gain in Children with Autism
Nashville, Tennessee
This trial is comparing two medicines, aripiprazole and risperidone, to see which one causes more weight gain in children with autism. The study focuses on children under 18 who have behavior problems like irritability and aggression. These medicines help by calming brain activity to improve behavior. The main goal is to find out which medicine leads to less weight gain over a few months. Aripiprazole and risperidone are both FDA-approved for treating irritability in children with autism.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:< 17
Key Eligibility Criteria
Disqualifiers:Age 18+, No Autism Diagnosis
Must Not Be Taking:Atypical Antipsychotics
350 Participants Needed
Tobacco Treatment for Smoking Cessation
Morganton, North Carolina
This study is to help determine the most effective type or combination of treatments to offer patients seeking lung cancer screening who are smokers to help them reduce the number of cigarettes they smoke, or quit smoking. The investigators long term goal is to increase the benefits of lung cancer screening by providing a blue print of best practices for screening sites to deliver tobacco treatment to their patients who are smokers, in a way that does not add burden to screening site staff and increases the chances of patients quitting smoking.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 4
Age:50 - 80
Key Eligibility Criteria
Disqualifiers:Recent Heart Attack, Unstable Angina, Others
Must Not Be Taking:NRT, Bupropion, Varenicline
807 Participants Needed
AV7909 Vaccine Booster for Anthrax
Knoxville, Tennessee
This trial tests the AV7909 vaccine on healthy adults aged 18-65 to see if it is safe and effective. The vaccine helps the body produce antibodies that can neutralize harmful substances. The AV7909 vaccine has shown to elicit a more robust immune response in older adults.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:HIV, Hepatitis B/C, Schizophrenia, Others
Must Not Be Taking:Herbal Medicines, Corticosteroids
220 Participants Needed
INBRX-106 + Pembrolizumab for Lung Cancer
Nashville, Tennessee
This is a Phase 1/2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp \& Dohme LLC, a subsidiary of Merck \& Co., Inc., Rahway, NJ, USA.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Hematologic Malignancies, CNS Metastases, Autoimmune Disease, Others
Must Not Be Taking:OX40 Agonists, Immunosuppressants
333 Participants Needed
COM701 for Ovarian Cancer
Germantown, Tennessee
The goal of this clinical trial is to learn if the experimental antibody COM701 delays the progression of ovarian cancer in participants with Relapsed Platinum Sensitive Ovarian Cancer. It will also learn about the safety of COM701.
The main questions the trial aims to answer are:
* Does COM701, when used as a maintenance treatment, stop or slow the progression of ovarian cancer?
* Does COM701 delay the time to needing a new anti-cancer treatment?
* What side effects do participants have when taking COM701?
Participants will:
* Visit the clinic once every 3 weeks during which the study treatment will be administered intravenously
* Undergo various tests and procedures to monitor general health throughout the trial including physical examinations, vital sign measurements (heart rate, blood pressure, breathing, and body temperature), weight measurements, electrocardiography (ECG), blood and urine tests and pregnancy tests if relevant.
* Undergo various tests and procedures to assess disease response throughout the trial including tumor imaging by CT scans or MRI to assess the tumor, its location, and size, and the testing of a sample of tumor tissue (from a prior biopsy or a fresh biopsy if feasible, to evaluate tumor response to treatment and to measure levels of tumor markers,
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Sex:Female
Key Eligibility Criteria
Disqualifiers:Liver Metastases, CNS Metastases, Hepatitis, HIV, Others
Must Not Be Taking:Steroids, Checkpoint Inhibitors
60 Participants Needed
VENT-02 for Parkinson's Disease
Memphis, Tennessee
This trial is a randomized, double-blind, placebo-controlled Phase 1b study evaluating the safety/tolerability, PK, and pharmacodynamics of VENT 02, administered orally at 1 dose level twice daily (BID) over 28 days in patients with mild to moderate Parkinson's disease.
The study includes a screening period, a 28-day double-blind treatment period, and a 7-day follow-up period after last dose.
Approximately 30 patients will be randomized into 1 of the 2 treatment arms.
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:45 - 90
Key Eligibility Criteria
Disqualifiers:Hepatitis, HIV, Dementias, Epilepsy, Others
Must Not Be Taking:Anticoagulants
30 Participants Needed
CVXGA Vaccine for Coronavirus
Gaffney, South Carolina
The purpose of this trial is to assess the safety and relative efficacy of CVXGA (CVXGA50), a KP.2 containing vaccine, compared to COMIRNATY® (COVID-19 Vaccine, mRNA; 2024-2025 Formula), a currently approved COVID-19 vaccine in the prevention of symptomatic, RT-PCR-confirmed SARS-CoV-2 infection. The trial will enroll up to 10016 healthy participants.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Acute Illness, Positive COVID-19, Autoimmune, Others
Must Not Be Taking:Intranasal Medications, Immunosuppressants
10016 Participants Needed
ECI830 + Ribociclib + Fulvestrant for Breast Cancer
Nashville, Tennessee
Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization/recommended dose for future studies.
Phase II: Assess the anti-tumor activity of ECI830 in combination with ribociclib and fulvestrant in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Heart Disease, CNS Metastases, Others
Must Be Taking:Ribociclib, Fulvestrant
280 Participants Needed
REC-1245 for Cancer
Nashville, Tennessee
This is a multi-center, open-label study to investigate the safety, tolerability, PK, PD, and preliminary activity of REC-1245 administered orally on a once daily (QD) schedule in participants with unresectable, locally advanced, or metastatic solid tumors.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:GI Malabsorption, Others
85 Participants Needed
EYE201 for Eye Conditions
Asheville, North Carolina
EYE-TIE-201 is a 2-part study to investigate the safety and effectiveness of a new drug being developed called EYE201.
All participants in the study will receive a total of 3 injections of EYE201 into the study eye, spaced at 4 weeks apart.
In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE201 will be assessed at increasing doses in branch retinal vein occlusion (BRVO) participants. Approximately 12 participants will be entered in this part of the study.
In the second part of the study, called the dose finding part, 2 doses of EYE201 will be selected and their effectiveness will be compared. This portion of the study assesses the safety and preliminary efficacy of EYE201 in patients with diabetic macular edema (DME) or neovascular macular degeneration (NVAMD). Approximately 80 participants will be entered in this part of the study.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, Uncontrolled Blood Pressure, Others
92 Participants Needed
CD388 Injection for Flu Prevention
Hendersonville, Tennessee
The purpose of this study is to evaluate the effectiveness of CD388 in preventing symptomatic laboratory-confirmed influenza infections, as compared to placebo, and to select a dose of CD388 that is effective in preventing the same, when administered as a single dose via 3 subcutaneous (SQ) injections to adult participants in stable health, and to evaluate the safety and tolerability of CD388, as compared to placebo.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Age:18 - 63
Key Eligibility Criteria
Disqualifiers:Influenza, COVID-19, Unstable Conditions, Others
Must Not Be Taking:Antivirals, Monoclonal Antibodies
5000 Participants Needed
CRB-601 Combination Therapy for Cancer
Nashville, Tennessee
The purpose of this study is to determine the safety, blood concentrations and treatment effect of CRB-601 in combination with immunotherapy in patients who have advanced solid tumors (cancer) and have exhausted other therapeutic options.CRB-601 targets a protein called avb8 integrin which is expressed by some cancers and not others. This study will focus on tumor types which are know to highly or moderately express this protein.
Researchers will evaluate the side effects caused by treatment, levels of CRB-601 in the blood, and the effect on the participant cancer. This will help researchers understand the right dose of CRB-601 to use for treatment and whether it is an effective treatment to combine with standard of care treatments such as immunotherapy. It will also help the researchers understand whether combining CRB-601 with standard-of-care immunotherapy and immune-priming radiotherapy is a safe and effective approach to treat cancer.
Participants in the study will receive CRB-601 via an infusion every two weeks either alone or in combination with immunotherapy.
There will be assessments to check on the participants general health status (including blood tests) and adverse effects. Participants will also receive regular CT or MRI scans to evaluate the effect of CRB-601 on their cancer. Participants will continue to visit the clinic every two weeks while they are receiving benefit from treatment. If their cancer progresses, participants will be asked to continue to be followed-up by the researchers to understand long-term outcomes, even if they receive other treatments.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Cardiovascular Events, Liver Disease, Autoimmune, Others
156 Participants Needed
Why Other Patients Applied
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"I was diagnosed with stage 4 pancreatic cancer three months ago, metastatic to my liver, and I have been receiving and responding well to chemotherapy. My blood work revealed that my tumor markers have gone from 2600 in the beginning to 173 as of now, even with the delay in treatment, they are not going up. CT Scans reveal they have been shrinking as well. However, chemo is seriously deteriorating my body. I have 4 more treatments to go in this 12 treatment cycle. I am just interested in learning about my other options, if any are available to me."
ID
Pancreatic Cancer PatientAge: 40
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
Gene Therapy for Chronic Granulomatous Disease
Nashville, Tennessee
This is an open-label, single-arm, multicenter Phase 1/2 study evaluating the safety and efficacy of gene therapy by transplantation of Prime Edited autologous CD34+ stem cells modified ex vivo (PM359) in participants with autosomal recessive Chronic Granulomatous Disease (CGD) caused by mutations in the NCF1 (Neutrophil Cytosolic Factor 1) gene.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Age:6+
Key Eligibility Criteria
Disqualifiers:HIV, Hepatitis B, Hepatitis C, Others
12 Participants Needed
Gene Therapy for Acute Lymphoblastic Leukemia
Nashville, Tennessee
This is a Phase 1/2, first-in-human, open-label, dose-escalating trial designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19-positive hematologic malignancies.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:13 - 90
Key Eligibility Criteria
Disqualifiers:Hepatoxicity, Thrombotic Microangiopathy, Cardiomyopathy, Others
32 Participants Needed
SMP-3124LP for Cancer
Nashville, Tennessee
An Open-label, Phase I Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Preliminary Antitumor Activity of SMP 3124LP in Adults with Advanced Solid Tumors
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:CNS Metastasis, Cardiac Disease, Others
Must Not Be Taking:CYP1A2 Inhibitors, CYP2D6 Inhibitors
120 Participants Needed
KK8123 for Hypophosphatemia
Nashville, Tennessee
A first-in-human study of KK8123 in adults with X-linked hypophosphatemia.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Active Infection, Uncontrolled Hypertension, Others
Must Not Be Taking:Vitamin D, Oral Phosphate
24 Participants Needed
Anti-VEGF Gene Therapy for Acoustic Neuroma
Nashville, Tennessee
This trial will evaluate the safety and tolerability of a single unilateral administration of one of three dose levels of AAVAnc80-antiVEGF and will evaluate the Akouos delivery device to safely achieve the intended product performance.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:NF2, Bilateral Vestibular Schwannoma, Others
27 Participants Needed
ADI-270 for Renal Cell Carcinoma
Nashville, Tennessee
This is a Phase 1/2 multicenter, open-label, dose escalation, and dose expansion study of ADI-270 - an Engineered gamma-delta Chimeric Receptor \[CAR\] Vδ1 T Cell product Targeting CD70 - in patients with R/R ccRCC.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:CNS Metastases, Active Malignancy, Others
Must Be Taking:Immune Checkpoint, VEGF Inhibitors
60 Participants Needed
2-HOBA for Alzheimer's Disease
Nashville, Tennessee
Investigators propose a phase 1b/2a, randomized, double-blind, placebo-controlled, parallel group dose finding and biomarker study to evaluate the safety, tolerability, and biomarker activity of 2-HOBA in 48 MCI/AD participants. Participants will be randomized 1:1:1:1 to receive 250, 500, 750 mg 2-HOBA acetate TID or placebo for 16 weeks. Blood and cerebral spinal fluid (CSF) will be collected to measure markers of protein modification by dicarbonyls (IsoLGs- \& MDA), pTau-181, YKL-40, and NF-L.
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 1, 2
Age:55 - 85
Key Eligibility Criteria
Disqualifiers:Parkinson's, Schizophrenia, Uncontrolled Diabetes, Others
Must Be Taking:Memantine, Cholinesterase Inhibitors
48 Participants Needed
mRNA Vaccine for Flu
Knoxville, Tennessee
The purpose of this study is to assess the safety and immune response of GlaxoSmithKlines (GSK) messenger RNA (mRNA)-based multivalent vaccine (GSK4382276A) candidate against influenza, administered in healthy younger adults (YA) and older adults (OA).
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Influenza, Malignancy, Immunodeficient, Neurological, Others
Must Not Be Taking:Immune-modifying Drugs
843 Participants Needed
IMP1734 for Advanced Solid Tumors
Nashville, Tennessee
This trial is testing a new drug called IMP1734 in patients with advanced breast, ovarian, and prostate cancers that have specific genetic mutations. The drug aims to block the cancer cells' ability to repair their DNA, which could stop the cancer from growing.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:CNS Metastases, Hepatitis B/C, Others
Must Be Taking:ADT
70 Participants Needed
Combination Therapy for Soft Tissue Sarcoma
Memphis, Tennessee
The study participant has been diagnosed with non-rhabdomyosarcoma (NRSTS).
Primary Objectives
Intermediate-Risk
* To estimate the 3-year event-free survival for intermediate-risk patients treated with ifosfamide, doxorubicin, pazopanib, surgery, and maintenance pazopanib, with or without RT.
* To characterize the pharmacokinetics of pazopanib and doxorubicin in combination with ifosfamide in intermediate-risk participants, to assess potential covariates to explain the inter- and intra-individual pharmacokinetic variability, and to explore associations between clinical effects and pazopanib and doxorubicin pharmacokinetics.
High-Risk
* To estimate the maximum tolerated dose (MTD) and/or the recommended phase 2 dosage (RP2D) of selinexor in combination with ifosfamide, doxorubicin, pazopanib, and maintenance pazopanib in high-risk participants.
* To characterize the pharmacokinetics of selinexor, pazopanib and doxorubicin in combination with ifosfamide in high-risk participants, to assess potential covariates to explain the inter- and intra-individual pharmacokinetic variability, and to explore associations between clinical effects and selinexor, pazopanib and doxorubicin pharmacokinetics.
Secondary Objectives
* To estimate the cumulative incidence of primary site local failure and distant metastasis-free, disease-free, event-free, and overall survival in participants treated on the risk-based treatment strategy defined in this protocol.
* To define and describe the CTCAE Grade 3 or higher toxicities, and specific grade 1-2 toxicities, in low- and intermediate-risk participants.
* To study the association between radiation dosimetry in participants receiving radiation therapy and the incidence and type of dosimetric local failure, normal adjacent tissue exposure, and musculoskeletal toxicity.
* To evaluate the objective response rate (complete and partial response) after 3 cycles for high-risk patients receiving the combination of selinexor with ifosfamide, doxorubicin, pazopanib, and maintenance pazopanib.
* To assess the relationship between the pharmacogenetic variation in drug-metabolizing enzymes or drug transporters and the pharmacokinetics of selinexor, pazopanib, and doxorubicin in intermediate- or high-risk patients.
Exploratory Objectives
* To explore the correlation between radiographic response, pathologic response, survival, and toxicity, and tumor molecular characteristics, as assessed through next-generation sequencing (NGS), including whole genome sequencing (WGS), whole exome sequencing (WES), and RNA sequencing (RNAseq).
* To explore the feasibility of determining DNA mutational signatures and homologous repair deficiency status in primary tumor samples and to explore the correlation between these molecular findings and the radiographic response, survival, and toxicity of patients treated on this protocol.
* To explore the feasibility of obtaining DNA methylation profiling on pretreatment, post-induction chemotherapy, and recurrent (if possible) tumor material, and to assess the correlation with this and pathologic diagnosis, tumor control, and survival outcomes where feasible.
* To explore the feasibility of obtaining high resolution single-cell RNA sequencing of pretreatment, post-induction chemotherapy, and recurrent (if possible) tumor material, and to characterize the longitudinal changes in tumor heterogeneity and tumor microenvironment.
* To explore the feasibility of identifying characteristic alterations in non-rhabdomyosarcoma soft tissue sarcoma in cell-free DNA (cfDNA) in blood as a non-invasive method of detecting and tracking changes during therapy, and to assess the correlation of cfDNA and mutations in tumor samples.
* To describe cardiovascular and musculoskeletal health, cardiopulmonary fitness among children and young adults with NRSTS treated on this protocol.
* To investigate the potential prognostic value of serum cardiac biomarkers (high-sensitivity cardiac troponin I (hs-cTnI), N-terminal pro B-type natriuretic peptide (NT-Pro-BNP), serial electrocardiograms (EKGs), and serial echocardiograms in patients receiving ifosfamide, doxorubicin, and pazopanib, with or without selinexor.
* To define the rates of near-complete pathologic response (\>90% necrosis) and change in FDG PET maximum standard uptake value (SUVmax) from baseline to week 13 in intermediate risk patients with initially unresectable tumors treated with induction pazopanib, ifosfamide, and doxorubicin, and to correlate this change with tumor control and survival outcomes.
* To determine the number of high-risk patients initially judged unresectable at diagnosis that are able to undergo primary tumor resection after treatment with ifosfamide, doxorubicin, selinexor, and pazopanib.
* To identify the frequency with which assessment of volumes of interest (VOIs) of target lesions would alter RECIST response assessment compared with standard linear measurements.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:< 30
Key Eligibility Criteria
Disqualifiers:CNS Metastases, Uncontrolled Hypertension, Others
Must Not Be Taking:CYP3A4 Substrates, Inhibitors, Inducers
139 Participants Needed
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We started Power when my dad was diagnosed with multiple myeloma, and I struggled to help him access the latest immunotherapy. Hopefully Power makes it simpler for you to explore promising new treatments, during what is probably a difficult time.
Bask GillCEO at Power
Frequently Asked Questions
How much do clinical trials in Tennessee pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do clinical trials in Tennessee work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across trials in Tennessee 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length in Tennessee is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility in Tennessee several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a medical study in Tennessee?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest clinical trials in Tennessee?
Most recently, we added DT2216 + Irinotecan for Cancer, 2-HOBA for Alzheimer's Disease and Gene Therapy for Acute Lymphoblastic Leukemia to the Power online platform.
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Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.