Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Anti-Infective Agents

All Drugs and Chemicals

Micronutrients

Antineoplastic Agents

Vitamins

Vitamin A

Retinol palmitate

Trace Elements

Antioxidants

Protective Agents

Retinol

Participants receive vitamin A compound PO for 7 consecutive days in the absence of disease progression or unacceptable toxicity. Within 21 days of completing treatment, participants then undergo surgical resection.

Description Participants undergo surgical resection.

Participants randomized to this arm will receive 7 consecutive days of of Vitamin A compound without disease progression or unacceptable toxicities. Within 21 days of completion of treatment participants will undergo surgical resection

Vitamin A Compound

Participants randomized to this arm will receive surgical resection

Therapeutic Conventional Surgery

William J Petty, MD

This trial studies how well high dose vitamin A compound works in treating participants with non-small cell lung cancer that can be removed by surgery. Vitamin A compound may increase the number of germinal centers (immune centers that make antibodies mature) in tumor and lymph tissues which may be beneficial to patients with cancer.

PRIMARY OBJECTIVES:

I. To compare the percentage of resected cancers containing germinal centers (GCs) in patients who receive neoadjuvant vitamin A compound (vitamin A) to controls.

SECONDARY OBJECTIVES:

I. To compare the abundance of GCs in adjacent lymph nodes in patients who receive neoadjuvant vitamin A to controls.

II. To compare histopathologic responses based on tumor necrosis in lung cancer patients who receive neoadjuvant vitamin A to controls.

III. To compare overall survival of patients who receive neoadjuvant vitamin A to controls.

EXPLORATORY OBJECTIVES:

I. To describe immunophenotypic changes of monocytes including myeloid derived suppressor cells (MDSCs) in pre- and post-treatment blood samples.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I: Participants receive vitamin A compound orally (PO) for 7 consecutive days in the absence of disease progression or unacceptable toxicity. Within 21 days of completing treatment, participants then undergo surgical resection.

GROUP II: Participants undergo surgical resection.

After completion of study treatment, participants are followed up for 30 days.

High Dose Vitamin A Compound in Treating Participants With Resectable Non-Small Cell Lung Cancer

A Pilot Study of Neoadjuvant High Dose Vitamin A for Resectable Non-Small Cell Lung Cancer

Presence/absence of germinal centers (GCs) in resected cancer tissues from patients who receive neoadjuvant vitamin A and controls.

Measurement of GCs per unit area in adjacent lymph nodes will be assessed using semi-quantitative designation (Score of high, moderate, low, or absent) in patients who receive neoadjuvant vitamin A and controls.

Pathologic response will be defined by tumor necrosis which will be dichotomized as present or absent in patients who receive neoadjuvant vitamin A and controls

Overall survival of patients receiving neoadjuvant Vitamin A and in controls.

National Cancer Institute (NCI)

Wake Forest University Health Sciences

Participants receive vitamin A compound PO for 7 consecutive days in the absence of disease progression or unacceptable toxicity. Within 21 days of completing treatment, participants then undergo surgical resection.

Vitamin A Compound: Participants randomized to this arm will receive 7 consecutive days of of Vitamin A compound without disease progression or unacceptable toxicities. Within 21 days of completion of treatment participants will undergo surgical resection

Description Participants undergo surgical resection.

Therapeutic Conventional Surgery: Participants randomized to this arm will receive surgical resection

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Study Coordinator

No samples were analyzed for outcomes and the study was stopped therefore data was not collected for outcome measures

Presence or Absence of Germinal Centers in Resected Tissue

Proportion of Germinal Centers in Lymph Nodes

Presence or Absence of Tumor Necrosis

Overall Survival

Overall Study

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

* Ablation Procedure- MWA will be used to treat solitary pulmonary nodules up to 3cm.
* CT scan will then be performed to evaluate the radiological changes 2 - 4 weeks after the ablation procedure.
* Surgery will be performed to remove the lung nodule and the tissue will be evaluated by pathology.

Microwave ablation of the solitary pulmonary nodule will be performed through a bronchoscopic approach using the AveCure Flexible Microwave Ablation Probe before surgery

AveCure 16 Gauge Flexible Microwave Ablation Probe

Jason Beattie, MD

Adnan Majid, MD

Mihir S Parikh, MD

Beattie Jason, MD

This research study to determine the effectiveness of the AveCure Flexible Microwave Ablation Probe to destroy cancerous lung nodules up to 3 c m in size.

This research study involves microwave ablation (MWA)

This will be a single arm, prospective cohort study.

The names of the study intervention involved in this study is:

* Cone Beam Computed Tomography (CBCT)-guided electromagnetic navigational bronchoscopy (ENB) microwave ablation (MWA)
* A rapid on-site evaluation (ROSE) will be performed before the MWA to confirm that the lesion is malignant, this can lead to longer procedure time and time under anesthesia.

The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.

* Participants will receive the study intervention and will be followed for 30 days.
* It is expected that about 10 people will take part in this research study.

This research study is a Pilot Study, which is the first-time investigators are examining this intervention using a bronchoscopic approach for microwave ablation of solitary pulmonary nodules.

The U.S. Food and Drug Administration (FDA) has approved this intervention as a treatment option for this disease.

Avecure Flexible Microwave Ablation Probe For Lung Nodules

Feasibility and Efficacy of the AveCure Flexible Microwave Ablation Probe for Peripheral Lung Nodule

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Feasibility of performing the procedure as planned in the enrolled patients. At least 9/10 of the planned ablations (90%) can be performed bronchoscopically according to the established protocol.

Pathological evaluation of the acute thermal effect produced by the AveCUre 16G-FMAP on targeted malignant solitary lung nodules will be described. The % necrosis, % viable tumor, and % stroma/inflammation present in the targeted nodules after ablation will be described.

A secondary analysis of the tissue surrounding the treated area will be performed. The % necrosis and of % stroma/inflammation will be described.

Immune-histochemical evaluation including TTF-1, Napsin-A, p40, or other immune-histochemical assessments will be performed if needed on a per case basis.

MedWaves, Inc

Dana-Farber Cancer Institute

Beth Israel Deaconess Medical Center

Principal Investigator

Rare Diseases

Small Cell Lung Carcinoma

Carcinoma, Small Cell

Small Cell Lung Cancer

Pembrolizumab

Carboplatin

Etoposide

Cisplatin

Etoposide phosphate

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Enzyme Inhibitors

Patients undergo radiation therapy and receive cisplatin or carboplatin on day 1 of each cycle and etoposide on days 1-3 for 4 cycles. Patients then receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo PET scan during screening. Patients also undergo MRI throughout the trial as well as CT. Additionally, patients undergo blood sample collection throughout the trial.

Computed Tomography

Positron Emission Tomography

Magnetic Resonance Imaging

Biospecimen Collection

Radiation Therapy

Vanderbilt-Ingram Services for Timely Access

Vanderbilt-Ingram Service Services for Timely Access

Ryan Ryan Whitaker, MD

Ryan Whitaker, MD, PhD

This phase II trial studies how well pembrolizumab after standard treatment with radiation plus the following chemotherapy drugs: cisplatin or carboplatin, plus etoposide works in treating patients with limited stage small cell lung cancer (LS-SCLC). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving pembrolizumab after standard treatment with radiation plus chemotherapy may increase the ability of the immune system to fight LS-SCLC.

PRIMARY OBJECTIVE:

I. To investigate progression free survival per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) as assessed by the investigator in patients with limited stage small cell lung cancer treated with adjuvant pembrolizumab.

SECONDARY OBJECTIVES:

I. Assess median overall survival compared to the historical control dataset (CONVERT trial1) median overall survival (OS) of 30 months.

II. Assess the safety and tolerability of adjuvant pembrolizumab in patients with limited stage SCLC.

EXPLORATORY/TRANSLATIONAL OBJECTIVES:

I. To determine whether patients with detectable circulating tumor deoxyribonucleic acid (ctDNA) after curative intent therapy ("minimal residual disease \[MRD\] positive") experience shorter median progression free survival (PFS) compared to patients without detectable ctDNA after curative intent therapy ("MRD negative.").

II. Determination of whether patients with ctDNA clearance at any point during curative intent therapy have superior median PFS compared to patients who do not experience ctDNA clearance during curative intent therapy.

OUTLINE:

Patients undergo radiation therapy and receive cisplatin or carboplatin on day 1 of each cycle and etoposide on days 1-3 for 4 cycles. Patients then receive pembrolizumab intravenously (IV) over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for 1 year in the absence of disease progression or unacceptable toxicity. Patients undergo positron emission tomography (PET) scan during screening. Patients also undergo magnetic resonance imaging (MRI) throughout the trial as well as computed tomography (CT). Additionally, patients undergo blood sample collection throughout the trial.

After completion of study treatment, patients are followed up at 30 days, and every 12 weeks for 2 years.

Pembrolizumab After Radiation Therapy and Chemotherapy in Limited Stage Small Cell Lung Cancer

A Single Arm Trial of Adjuvant Pembrolizumab in Patients With Limited Stage Small Cell Lung Cancer

Will be assessed by National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0. Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment.

Merck Sharp & Dohme LLC

Vanderbilt-Ingram Cancer Center

Assistant Professor of Medicine

Fluorides

Fluorodeoxyglucose F18

Deoxyglucose

Radiopharmaceuticals

Antimetabolites

Antiviral Agents

Participants receive fludeoxyglucose F-18 IV and after 60 minutes undergo positron emission tomography (PET) within 4 weeks of the first planned stereotactic body radiation therapy (SBRT) fraction, prior to the second planned fraction, and prior to the fifth planned fraction.

Fludeoxyglucose F-18

Positron Emission Tomography (PET)

Stereotactic Body Radiation Therapy (SBRT)

Kristin Higgins, MD

This trial studies how well fludeoxyglucose F-18 - positron emission tomography (PET) works in planning radiation therapy in participants with early non-small cell lung cancer, early stage lung cancer, or cancer that has spread to lungs from other parts of the body. Using PET in addition to the standard computed tomography to plan radiation therapy for cancer may help doctors to maximize the dose to the cancer and minimize the dose to normal tissues.

PRIMARY OBJECTIVE:

To determine the maximum inter-fraction variability of fludeoxyglucose F-18 (18-F FDG)-PET activity of thoracic tumor treatment volumes through a 5-fraction stereotactic body radiation therapy (SBRT) course as it relates to the planning feasibility of emission-guided radiation therapy, or biologically-guided radiation therapy (BgRT).

SECONDARY OBJECTIVES:

I. To compare similar inter-fraction variability of FDG-PET activity for non-thoracic SBRT target volumes for the purpose of determining the feasibility of BgRT.

II. To compare dosimetric endpoints for primary tumor coverage and dose to organs at risk between conventional SBRT planning and simulated BgRT, or emission-guided radiation therapy planning for thoracic and non-thoracic targets.

III. To compare dosimetry for primary tumor coverage and dose to organs at risk between adaptive cone beam computed tomography (CT) planning, and simulated adaptive emission-guided radiation therapy (BgRT) planning for thoracic and non-thoracic targets.

IV. To compare variability of 18-F FDG-PET in patients undergoing immunotherapy simultaneously during SBRT, or within 4 weeks of SBRT treatment with patients undergoing SBRT but not receiving immunotherapy.

OUTLINE:

Participants receive fludeoxyglucose F-18 intravenously (IV) and after 60 minutes undergo PET within 4 weeks of the first planned SBRT fraction, prior to the second planned fraction, and prior to the fifth planned fraction.

Fludeoxyglucose F-18-PET in Planning Lung Cancer Radiation Therapy

A Pilot Study of FDG-PET Variability to Establish Biology-Guided Treatment Planning Feasibility for Stereotactic Body Radiation Therapy

Metabolic tumor volumes across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients and for every tumor treated with SBRT.

Total lesion glycolysis values across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients and for every tumor treated with SBRT.

Metabolic tumor volumes across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients.

Total lesion glycolysis values across the treatment continuum, i.e. pre-treatment, before second fraction and before the last fraction of treatment, will be compared. The observed % change from baseline will be calculated at all time points for all 15 patients.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
High Dose Vitamin A Compound in Treating Participants With Resectable Non-Small Cell Lung Cancer	NCT03870529	Non Small Cell ... Stage I Lung Ca... Stage Ib Lung C... Stage IA Lung C... Stage IIA Lung ... Stage IIIA Lung...	Vitamin A Compo... Therapeutic Con...	18 Years -	Wake Forest University Health Sciences
High Dose Vitamin A Compound in Treating Participants With Resectable Non-Small Cell Lung Cancer	NCT03870529	Non Small Cell ... Stage I Lung Ca... Stage Ib Lung C... Stage IA Lung C... Stage IIA Lung ... Stage IIIA Lung...	Vitamin A Compo... Therapeutic Con...	18 Years -	Wake Forest University Health Sciences
Avecure Flexible Microwave Ablation Probe For Lung Nodules	NCT05281237	Stage I - II Pr... Stage I Lung Ca... Stage II Lung C... Lung Cancer Sta... Lung Cancer Sta... Lung Cancer	AveCure 16 Gaug...	22 Years -	Beth Israel Deaconess Medical Center
Pembrolizumab After Radiation Therapy and Chemotherapy in Limited Stage Small Cell Lung Cancer	NCT06140407	Limited Stage L... Stage I Lung Ca... Stage II Lung C... Stage III Lung ...	Cisplatin Carboplatin Etoposide Pembrolizumab Computed Tomogr... Positron Emissi... Magnetic Resona... Biospecimen Col... Radiation Thera...	18 Years -	Vanderbilt-Ingram Cancer Center
Fludeoxyglucose F-18-PET in Planning Lung Cancer Radiation Therapy	NCT03493789	Stage I Lung Ca... Stage I Non-Sma... Stage IA Non-Sm... Stage IB Non-Sm... Stage II Lung C... Stage II Non-Sm... Stage IIA Non-S... Stage IIB Non-S...	Fludeoxyglucose... Positron Emissi... Stereotactic Bo...	18 Years -	Emory University
Fludeoxyglucose F-18-PET in Planning Lung Cancer Radiation Therapy	NCT03493789	Stage I Lung Ca... Stage I Non-Sma... Stage IA Non-Sm... Stage IB Non-Sm... Stage II Lung C... Stage II Non-Sm... Stage IIA Non-S... Stage IIB Non-S...	Fludeoxyglucose... Positron Emissi... Stereotactic Bo...	18 Years -	Emory University

Spots Global Cancer Trial Database for stage i lung cancer