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8 Study Matches

Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy with Concurrent Cetuximab in Patients with Locoregionally Advanced Head and Neck Cancer with a Contraindication to Cisplatin

The purpose of this study is to compare any good and bad effects of usual radiation plus the study treatment drug (durvalumab), to the usual therapy of radiation plus the drug (cetuximab) in patients with head and neck cancer who cannot take the drug cisplatin.

The purpose of this study is to compare any good and bad effects of usual radiation plus the study treatment drug (durvalumab), to the usual therapy of radiation plus the drug (cetuximab) in patients with head and neck cancer who cannot take the drug cisplatin.

Yes
 

Mitchell Machtay
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03258554
SITE00000527
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Inclusion Criteria:
squamous cell carcinoma
18 or older
Adequate hematologic function
Adequate hepatic function
Adequate renal function

Exclusion Criteria:
invasive malignancy within the past 3 years
Prior radiotherapy
Prior immunotherapy
Major surgery within 28 days prior to Step 1 registration
Uncontrolled hypertension
Cancer
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Hershey, PA ,

A Phase II/III Study of Maintenance Nivolumab versus Observation in HPV Positive OPCA (PSCI# 20-016) (EA3161)

The purpose of this study is to compare the usual treatment alone (radiation and chemotherapy) to adding maintenance nivolumab to the usual treatment. The addition of nivolumab to the usual treatment could shrink your cancer or prevent it from returning. But, it could also cause side effects, which are described in the risks section below.This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the nivolumab increases the lifetime of the patient without progression for 10 years.This immunotherapy drug, nivolumab, is already approved by the FDA for use in advanced and incurable head and neck cancer. But, most of the time it is not used until the cancer is very advanced and chemotherapy stops working. In this study we believe the use of nivolumab has a chance of preventing the cancer from coming back for patients with your type of cancer. There will be about 286 people taking part in the first part (phase II) of the study and 458 more people taking part in second part (phase III), if the results of the phase II portion are promising and if there is evidence that nivolumab may prolong your life.

The purpose of this study is to compare the usual treatment alone (radiation and chemotherapy) to adding maintenance nivolumab to the usual treatment.

Yes
 

Mitchell Machtay
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03811015
SITE00000750
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Inclusion Criteria:
Age ≥ 18 years.
ECOG performance status of 0 or 1.
Patients must have oropharynx cancer that is p16-positive by immunohistochemistry
Adequate baseline organ and marrow function
Adequate baseline liver functionality

Exclusion Criteria:
Patients with a history of allergic reactions attributed to platinum based chemotherapy agents
Patients must not have had prior systemic therapy or radiation treatment for p16 positive OPSCC
Patients must not have received previous irradiation for head and neck, tumor, skull base, or brain tumors
Patients must not have known hypersensitivity to nivolumab
Patients with evidence of distant metastases or leptomeningeal disease are excluded
Cancer
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Hershey, PA ,

PSCI 22-120 A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of AAV2-hAQP1 Gene Therapy in Participants with Radiation-Induced Late Xerostomia

This trial will be comparing two doses of AAV2-hAQP1 against a placebo for patients with head and neck cancer who have severe dry mouth from receiving radiation.

Patient's will be required to come to all study visits, reports any signs and symptoms they are having and all medications they are taking. You will be required to come in for 2 pre screening visits that will include signing the consent, collecting of saliva, completing questionnaires, seeing the study doctor, having blood drawn, providing a urine specimen to see if you qualify to participate. If you meet the qualifications to participate you will have one visit in which you will receive medication to dry your mouth, than the study doctor will place the medication into the glands in your mouth that produce saliva. You will then be requires to come in the next week for additional saliva collection and to see the study doctor. After that you will come in monthly to see the study doctor too see how you are feeling,complete questionnaires and provide a urine specimen.

dependent upon miles traveled

Yes
 

Neerav Goyal
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Otolaryngology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05926765
STUDY00023058
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Inclusion Criteria:
Male or female
Age ≥18 years
Able to understand the investigational nature, potential risks, and benefits of the study, and to provide valid informed consent to enroll in this study and in the long-term follow-up study
Completed beam radiation therapy for head and neck cancer at least 3 years prior to the first screening visit
No history of recurrent cancer or a second primary cancer

Exclusion Criteria:
Any malignancy within the preceding 3 years, except for treated basal cell or squamous cell carcinoma of the skin or in situ cervical carcinoma
Any experimental therapy within 3 months prior to the first screening visit
Previous treatment with a gene or cell therapy
History of systemic autoimmune disease affecting the salivary glands (e.g., Sjogren’s disease)
Currently using systemic immunosuppressive medication(s)
Cancer
Experimental drug compared to an approved drug
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Hershey, PA ,

Randomized Phase II/III Trial of Radiation with High-Dose Cisplatin (100 mg/m2) Every Three Weeks versus Radiation with Low-Dose Weekly Cisplatin (40 mg/m2) for Patients with Locoregionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) (PSCI# 21-207) (NRG-HN009)

The purpose of this study is to compare two usual treatment approaches to your head and neck cancer: high-dose cisplatin given every 3 weeks with radiation to low-dose cisplatin given weekly with radiation. The first part of this study will help the study doctors find out if the low-dose cisplatin approach is better tolerated than the high-dose cisplatin approach. To decide if it is better, the study doctors will be looking to see if there are fewer side effects for patients who receive low-dose cisplatin weekly compared to patients who receive high-dose cisplatin every 3 weeks. The second part of this study will also help the study doctors find out if the low-dose cisplatin approach will extend your life by at least the same amount of time as the high-dose cisplatin approach. There will be 464 people in the first part of the study. If the study goes on to the second part, there will be 786 additional people. Overall, there will be a total of up to 1250 people taking part in this study.

he first part of this study will help the study doctors find out if the low-dose cisplatin approach is better tolerated than the high-dose cisplatin approach. To decide if it is better, the study doctors will be looking to see if there are fewer side effects for patients who receive low-dose cisplatin weekly compared to patients who receive high-dose cisplatin every 3 weeks.The second part of this study will also help the study doctors find out if the low-dose cisplatin approach will extend your life by at least the same amount of time as the high-dose cisplatin approach.There will be 464 people in the first part of the study. If the study goes on to the second part, there will be 786 additional people. Overall, there will be a total of up to 1250 people taking part in this study.

Yes
 

Sean Mahase
PSCI-CTO@pennstatehealth.psu.edu
Radiation Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05050162
SITE00001120
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Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of SCCHN of the oropharynx, larynx, hypopharynx, or p16-positive unknown primary prior to registration
Age ≥ 18
Zubrod (ECOG) performance status of 0-1 within 14 days prior to registration
Adequate hematologic function within 30 days prior to registration
Adequate renal function within 30 days prior to registration defined as calculated creatinine clearance (CrCl) ≥ 50 mL/min by the Cockcroft-Gault formula

Exclusion Criteria:
Patients with oral cavity cancer, nasopharynx cancer, or p16-negative cancer of unknown primary (CUP);
Definitive clinical or radiologic evidence of distant metastatic disease
Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable, however, any prior exposure to cisplatin is excluded
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Pregnancy and individuals unwilling to discontinue nursing
Cancer
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Hershey, PA ,

Digital tools for assessment of motor functions and falls in ALS

This is a 48-week, two arm study that incorporates digital tools for assessing motor function in amyotrophic lateral sclerosis (ALS) and healthy controls.During the study, neck- and wrist-worn “activity sensors” (PAMSys, BioSensics, Newton, MA) will be worn by subjects while performing tasks of daily living. Subjects will also complete a motor, speech, and handwriting assessment during site visits. They will complete a digital home assessments of speech, handwriting, and pattern tracing tasks throughout the study, and report any falls which occur on the study tablet. We will explore whether sensor-based functional changes are sensitive to self-reported changes over the length of the study.

During the study, neck- and wrist-worn “activity sensors” (PAMSys, BioSensics, Newton, MA) will be worn by subjects while performing tasks of daily living. Subjects will also complete a motor, speech, and handwriting assessment during site visits. They will complete a digital home assessments of speech, handwriting, and pattern tracing tasks throughout the study, and report any falls which occur on the study tablet.Subjects will be required to visit the study site around the time of 5 consecutive standard ALS clinic appointments.The research study will last approximately 48 weeks.

$240

Yes
 

Andrew Geronimo
Wint Nandar - at wnandar@pennstatehealth.psu.edu
Neurosurgery (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
NCT05271435
STUDY00013892
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Inclusion Criteria:
Diagnosis of amyotrophic lateral sclerosis (ALS), primary lateral sclerosis (PLS), or progressive muscular atrophy (PMA), or a control subject
18 years of age or older
Walking with or without mobility support (such as a cane or walker)
Fluent in written and spoken English

Exclusion Criteria:
Neurological or orthopedic problems independent of inclusionary diagnosis that affects gait
Pregnant or nursing woman
Prisoner or institutionalized individuals
Have any clinically relevant medical history of other disease or diseases that, in the opinion of the research team, exclude the subject from participation (including severe cognitive dysfunction).
Neurology
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Hershey, PA ,

PHASE I SAFETY ASSESSMENT OF HYPOFRACTIONATED POSTOPERATIVE RADIOTHERAPY (H-PORT) FOR INTERMEDIATE-RISK HEAD AND NECK CANCER

The purpose of this study is to test the good and bad effects of using hypofractionated radiation therapy. Hypofractionated radiation therapy could shrink or stabilize your cancer, but it could also cause side effects. The study doctors hope to learn if hypofractionated radiation therapy is safe and tolerable in patients with your type of cancer. You will receive radiation therapy for 4 weeks. You may also receive chemotherapy.

Participants will be required to receive radiation therapy for 4 weeks. Participants may also receive chemotherapy with cisplatin, carboplatin, or cetuximab.

Yes
 

Mitchell Machtay
PSCI-CTO at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05540899
STUDY00022103
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Inclusion Criteria:
Pathologically (histologically) proven diagnosis of squamous cell carcinoma (including variants such as verrucous carcinoma, spindle cell carcinoma, carcinoma NOS, etc.) of the head/neck
Clinical stage II, III or IVA squamous cell carcinoma of the oral cavity, oropharynx or larynx (AJCC 8th edition), including no distant metastases.
Total resection of the patient’s cancer (i.e. no residual disease after total resection of the patient’s cancer ).
One or more indications for postoperative radiotherapy, based upon pathologic findings: • Perineural invasion; • Lymphovascular invasion;
Zubrod Performance Status 0-1

Exclusion Criteria:
Recurrence of the study cancer.
History of systemic lupus erythematosus or systemic sclerosis (scleroderma).
Pregnancy and individuals unwilling to discontinue nursing.
Feeding tube (gastric or jejuno) at the time of registration.
Anticipated need for high-dose systemic chemotherapy (e.g. high dose q3-week cisplatin), multiple systemic therapy agents or immunotherapy. Weekly single-agent systemic therapy with cisplatin, carboplatin, or cetuximab is allowable.
Cancer
Not applicable
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Hershey, PA ,

Dysgeusia and Anosmia in Head and Neck Cancer Patients: Long Term Outcomes

The primary aim of this study is to understand taste changes after head and neck cancer treatment, especially long term taste disturbance, using various methods including online surveys, Teams interviews, at home taste and smell tests, and MRIs.

The purpose of this voluntary research study is to identify taste changes in patients treated for head and neck cancer. We are recruiting healthy participants over the age of 40 as well as head and neck cancer survivors who were treated 3 or more years ago. The overall study consists of multiple parts, which are explained along the way. You can choose to participate in this portion, which is an online survey, and nothing else, or all of the invited components. •The survey will take approximately 10 minutes of your time. •Completion of this survey is voluntary and you are not required to complete it if you do not wish to do so.•At the end of the survey you will be asked about your willingness to participate in other portions of this study. These include at-home taste and smell tests over Teams and a Teams interview about your taste and smell function. Participating in these tasks is optional and not required. If you complete the smell and taste tests at home you may be invited to have an MRI scan.

Max of $75: No compensation for the survey, $15 giftcard for 1-hour interview (optional), $15 giftcard for at-home taste/smell tests (optional), $50 giftcard for MRI at Hershey Med Center (optional).

No
 

Neerav Goyal
Hanel Eberly - at HNCtaste@pennstatehealth.psu.edu
Otolaryngology (HERSHEY)
 

All
18 year(s) or older
This study is also accepting healthy volunteers
STUDY00019457
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Inclusion Criteria:
Able to give consent
Over the age of 40
English Speaking

Exclusion Criteria:
Under 40 years of age
have undergone a total glossectomy
currently have an upper respiratory infection, sinus infection, or ear infection
Cancer
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PSCI #24-150 A Phase 3 Open-Label, Randomized Study of PDS0101 Plus Pembrolizumabvs Pembrolizumab Alone in First Line Treatment of Immune Checkpoint Inhibitor (ICI) Naïve Subjects with Unresectable Recurrent and/or Metastatic (R/M) Human Papillomavirus 16 (HPV16)-Positive Head and Neck Squamous Cell Carcinoma (HNSCC).

This study will see if pembrolizumab alone or with PDS0101 is the better treatment for head and neck cancer.

Participants will need to come to all study visits, take the study medication as prescribed, tell the study team how you are feeling and report to the study team all new medications you are tsking including over the counter medications.

Yes
 

Danh Pham
PSCI-CTO@pennstatehealth.psu.edu 717-531-5471
Medicine: Hematology and Medical Oncology (HERSHEY)
 

All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT06790966
STUDY00026812
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Inclusion Criteria:
Subject is ≥18 years
Have a history of histologically- or cytologically-confirmed diagnosis of recurrent and/or metastatic squamous cell cancer of the head and neck
Subject has adequate organ function

Exclusion Criteria:
Primary tumor location of nasopharynx
Has had major surgery, including surgical resection of tumor, within 30 days prior
Has received radiotherapy prior
Cancer
Experimental drug compared to an approved drug
I'm interested
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Hershey, PA ,