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Suggestions within category "Cancer"


9 Study Matches

KEYSTROKE: A RANDOMIZED PHASE II STUDY OF PEMBROLIZUMAB (KEYTRUDA®) PLUS STEREOTACTIC RE-IRRADIATION VERSUS SBRT ALONE FOR LOCOREGIONALLY RECURRENT OR SECOND PRIMARY HEAD AND NECK CARCINOMA

Study of Pembrolizumab (KEYTRUDA®) Plus non-surgical radiation therapy Versus non-surgical radiation therapy alone for Recurrent or Second Primary Head and Neck Cancer. This study is evaluating the safety of the addition of pembrolizumab to non-surgical radiation therapy.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03546582
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Inclusion Criteria:
Confirmed diagnosis of recurrent or any new primary squamous cell carcinoma of the head and neck
Patients for whom resection would be medically contraindicated and/or would impose excessive surgical risk
Patients must have had prior radiation to the head and neck
Exclusion Criteria:
Patients with distant metastases
Tumors that involve more than 180 degrees of the carotid artery
Patients with tumor ulceration through the skin
Disease that requires two or more discontiguous target volumes will be ineligible.
Cancer
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Hershey, PA

Site for MRI Brain Surveillance Alone Versus MRI Surveillance and Prophylactic Cranial Irradiation (PCI): A Randomized Phase III Trial in Small-Cell Lung Cancer (MAVERICK) (S1827) (PSCI# 20-086)

The purpose of this study is to compare the effects of using brain MRIs alone versus brain MRIs plus PCI on the lifespan of patients with small cell lung cancer. The use of brain MRIs alone could reduce side effects of receiving PCI. This study is hoping to show that monitoring with MRI scans alone (delaying radiation until the actual spread of the cancer) is at least as good as the combination of PCI with MRI scans. There will be about 668 people taking part in this study.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04155034
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Inclusion Criteria:
Patient must have a histologically confirmed diagnosis of small-cell lung cancer (SCLC).
Patient must have an MRI of the brain performed within 28 days prior to registration.
Patient must have Zubrod Performance Status of 0-2
Patient must be ≥ 18 years of age.
All adverse events from prior treatment must have resolved to ≤ Grade 2 (CTCAE Version 5.0) prior to randomization.
Exclusion Criteria:
Patient must not have a contraindication to gadolinium contrast administration during MR imaging, such as allergy or insufficient renal function
Patient must not have other metastatic malignancies requiring current active treatment.
Patient must not have any severe active comorbidities
Patient must not have received prior radiotherapy to the brain or whole brain radiotherapy.
Patient must not have a contraindication to MR imaging, such as implanted metal devices or foreign bodies
Cancer
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Hershey, PA

Site for Randomized Phase II/III Trial of Adjuvant Radiation Therapy with Cisplatin, Docetaxel-Cetuximab, or Cisplatin-Atezolizumab in Pathologic High-Risk Squamous Cell Cancer of the Head and Neck (PSCI# 20-106) (RTOG-1216)

To determine if the combination of atezolizumab, cisplatin, and IMRT is superior to standard cisplatin and IMRT in the HNSCC.
Irina Geier at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT01810913
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Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of head and neck squamous cell carcinoma
Patients must have undergone gross total surgical resection of high-risk oral cavity, oropharynx (p16 Negative), larynx, or hypopharynx within 63 days prior to registration
Pathologic stage III or IV HNSCC, including no distant metastases
Zubrod Performance Status of 0-1 within 14 days prior to registration
Adequate hepatic function
Exclusion Criteria:
Prior systemic chemotherapy or anti-EGF therapy for the study cancer; note that prior chemo for a different cancer is allowable
Severe, active co-morbidity
Grade 3-4 electrolyte abnormalities
Prior allergic reaction to cetuximab
Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
Cancer
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Hershey, PA

Site for 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.
Irina Geier at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03258554
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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 Pilot Study to evaluate the pharmacokinetic, pharmacodynamic, and resistance profile to trametinib and dabrafenib in BRAF-V600E mutated recurrent gliomas

This research is being done to understand how much of two drugs (dabrafenib and trametinib) is able to enter brain tumors and how well the drugs are able to turn off this pathway in brain tumors. The study will also look at how tumors lose sensitivity to this treatment. People with primary brain tumors who are already taking dabrafenib and trametinib and who need a brain surgery are eligible for this study. Biospecimens (tissue, blood, and cerebrospinal fluid (CSF)) taken during the surgery will help us understand how much of these two study drugs actually get into the brain, their effect, and how the tumors become resistant to treatment.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
N/A
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Inclusion Criteria:
At least 18 years old
Subjects must have a history of primary brain tumor (including but not limited to glioblastoma (GBM), anaplastic astrocytoma (AA), anaplastic ganglioglioma (AG), and anaplastic pleomorphic xanthoastrocytoma (PXA)).
Subjects must have a BRAF-V600 mutation identified in previous tissue analysis (may be IHC or PCR based). Allowable mutations include V600E, V600K, V600R, and V600D.
Subjects must be taking dabrafenib at a dose of at least 50mg twice daily (adults only) and / or trametinib at a dose of at least 1mg daily (adults only) for at least 7 days prior to surgery as prescribed by their treating physician.
Subjects must be undergoing surgery for clinical purposes
Exclusion Criteria:
Younger than 18 year old
Subjects who are receiving any other investigational agents or chemotherapeutic agents.
Neurology, Cancer
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Hershey, PA

A Phase II, Randomized, Open-Label Three-Arm Clinical Study To Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination with Pembrolizumab (MK-3475) versus Standard of Care Chemotherapy and Lenvatinib Monotherapy in Participants with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) that have Progressed after Platinum Therapy and Immunotherapy (PD-1/PD-L1 inhibitors) (LEAP-009)

This study is designed to compare pembrolizumab plus lenvatinib as a combination therapy and standard of care (SOC) chemotherapy and see if its safe and effective for patients with recurrent or metastatic head and neck squamous cell carcinoma.
Irina Geier at igeier@pennstatehealth.psu.edu or 717-531-8678
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04428151
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Inclusion Criteria:
Be male or female and at least 18 years of age on the day of signing informed consent.
Have histologically confirmed recurrent (not amenable to curative treatment with local and/or systemic therapies) or metastatic (disseminated) HNSCC
Have experienced disease progression at any time during or after treatment with a platinum-containing (eg, carboplatin or cisplatin) regimen with or without cetuximab.
Have submitted pre-study imaging that demonstrates evidence of disease progression based on investigator review of at least 2 pre-study images per RECIST 1.1,
Have provided tissue for PD-L1 biomarker analysis from a core or excisional biopsy (fine needle aspirate is not adequate) not previously irradiated.
Exclusion Criteria:
Has carcinoma of the nasopharynx, salivary gland, unknown primary origin, or nonsquamous histologies as primary tumors.
Has a history of re-irradiation to any head and neck sites of disease including the cervical, infraclavicular or supraclavicular lymph nodes for head and neck cancer.
Has a life expectancy of less than 3 months and/or has rapidly progressing disease
Has any evidence of symptoms or signs of active tumor bleeding within 6 months prior to randomization
Has a history of (noninfectious) pneumonitis that required systemic steroids, or current pneumonitis/interstitial lung disease.
Cancer
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Hershey, PA

Standard Chemotherapy versus Chemotherapy Chosen by Cancer Stem Cell Chemosensitivity Testing in the Management of Patients with Recurrent Glioblastoma Multiforme (GBM).and recurrent WHO Grade III Glioma. CSCRGBM

The investigational purpose of this study is to screen chemotherapy drugs currently used for the care of recurrent glioblastoma and recurrent grade III glioma (a form of brain cancer) and to determine the most effective treatment based on results from a chemosensitivity assay. Chemosensitivity drug assay refers to testing a patient's own cancer cells in the laboratory to drugs that are to be used to treat the patient's cancer. Following surgery or biopsy, you will be treated either as per chemotherapy agents chosen by the physician or with chemotherapies as suggested by the results of the chemosensitivity testing. The study is looking to determine if patients treated with drugs predicted by the chemosensitivity test have better outcomes than patients treated with drugs chosen by the treating physician.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03632135
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Inclusion Criteria:
Histopathologically confirmed WHO grade IV recurrent astrocytoma (recurrent GBM)
Recurrent surgically resectable tumor
Estimated survival of at least 3 months;
Exclusion Criteria:
Subjects with newly diagnosed GBM
Pregnant women or nursing mothers cannot participate in the study. Women of childbearing age must have a negative pregnancy test within 72 hours prior to study entry.
Neurology, Cancer
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Hershey, PA

3D-PREDICT REGISTRY: 3D Prediction of Patient-specific Response using Ex vivo Interrogation of Live Cells from Tumors

Patients are being asked to participate in this study because they may have one of the following: Brain Cancer (high-grade gliomas (HGG) that are limited to Glioblastoma Multiforme (GBM) or Anaplastic Astrocytoma (AA)). This study will collect data for a registry that records how a patient's cancer tissue responds to different types of approved chemotherapy drugs. The results of the responses will be shared with the patient's physician. The purpose of this study is to measure the accuracy of new investigational laboratory tests which could predict which chemotherapies are most active to each individual patient’s tumor. KIYATEC has validated a test, the Ex-Vivo 3-Dimensional Drug Response Assay (EV3D, the Assay) prior to use in this study. In this study, KIYATEC will establish the clinical correlation and utility of the Assay in various cancer subtypes.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03561207
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Inclusion Criteria:
Age 18 years and older
Diagnosis of or suspected diagnosis of glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA)
Patient must undergo elective surgery or biopsy to remove tumor tissue
Consideration as a candidate for systemic therapy with cytotoxic chemotherapy, targeted small molecule inhibitors or immunotherapy
Exclusion Criteria:
Age of <18 years
Do not have a diagnosis of or suspected diagnosis of glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA)
Patient will not have surgery or a biopsy as part of routine clinical practice
Patient has known active cancer metastatic to the brain except for patients with brain metastases that have been treated and are considered stable
Patient refuses to have the assay performed on their tissue
Neurology, Cancer
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Hershey, PA

Site for A Phase II/III Randomized Study of Maintenance Nivolumab versus Observation in Patients with Locally Advanced, Intermediate Risk 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.
Irina Geier at PSCI-CTO@pennstatehealth.psu.edu or 717-531-5471
Male
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03811015
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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