Consecutively admitted patients with pancreatic cancer confirmed by EUS-guided FNA.
EG-EUS and CE-EUS will be applied in all patients.

Consecutively admitted patients with benign pancreatic masses with negative EUS-guided FNA.
EG-EUS and CE-EUS will be applied in all patients.

Consecutively admitted patients with malignant lymphnodes confirmed by EUS-guided FNA.
EG-EUS will be applied in all patients.

Consecutively admitted patients with benign lymphnodes with negative EUS-guided FNA.
EG-EUS will be applied in all patients.

Pancreas and lymphnode samples (EUS-guided fine needle aspiration)

Pancreatic Cancer

Secondary Malignant Neoplasm of Lymph Node

Benign Neoplasm of Lymph Nodes

Benign Pancreatic Tumors

Elastography is an ultrasound method used for the reconstruction of tissue elasticity distribution in real-time. The main intended use is to differentiate between benign and malignant focal lesions based on the significantly smaller strain of the latter real time. Tissue elastography can be easily performed with conventional probes, including the linear EUS probes used for the examination of the pancreas and/or lymph nodes.
Contrast-enhancement Ultrasound contrast agents in conjunction with contrast specific imaging techniques are increasingly accepted in clinical use for diagnostic imaging. Pancreatic adenocarcinomas are usually hypovascular tumors.

Elastography, contrast enhancement

Research Center in Gastroenterology and Hepatology, University of Medicine and Pharmacy

Clinical Impact of EUS Elastography Mean Strain Histograms (SH) and Contrast Peak-enhancement in Focal Pancreatic Masses and Lymph Nodes

Real-time Semi-quantification of Endoscopic Ultrasound Elastography and Contrast-enhancement Using Strain Histograms (SH) and Contrast-enhancement (CE) for the Differentiation of Focal Pancreatic Masses and the Assessment of Lymph Node Involvement

University of Medicine and Pharmacy Craiova

Institut Paoli-Calmettes

Caritas-Krankenhaus Bad Mergentheim

San Raffaele University Hospital, Italy

Tel-Aviv Sourasky Medical Center

University of Santiago de Compostela

Shengjing Hospital

Previously collected tissue samples are analyzed by IHC.

Lung Cancer

Laboratory Biomarker Analysis

SUNY Upstate Medical University

Biomarkers in Predicting Response in Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy

Participation in the Lung Adjuvant Cisplatin Evaluation Biological Program (LACE-BIO). A Study of Prognostic and Predictive Markers in Early Stage Non-Small Cell Lung Cancer

Alliance for Clinical Trials in Oncology

National Cancer Institute (NCI)

Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.

Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin 1(MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.

Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.
PANVAC-V : given subcutaneously
Sargramostim : given subcutaneously (NCI subjects only)
PANVAC-F : given subcutaneously
Docetaxel : given IV

Arm I - PANVAC + Docetaxel

Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.
Docetaxel : given intravenous (IV)

Arm II - Docetaxel Alone

Total

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Region of Enrollment

Time between the first day of treatment and disease progression. Progression is assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Progressive disease is a minimum of 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new measurable lesions.

Progression-free Survival (PFS)

Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.

Number of Participants With Adverse Events

Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.
PANVAC-V: given subcutaneously
Sargramostim : given subcutaneously (NCI subjects only)
PANVAC-F : given subcutaneously
Docetaxel : given IV

Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin 1(MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.
Docetaxel : given intravenous (IV)

Treatment

Crossover

Dr. James Gulley, M.D., Ph.D.

Breast Cancer

35 mg/m^2 intravenous 30-60 minutes once a week for 3 consecutive weeks with 1 week off drug.

Docetaxel

PANVAC-V

PANVAC-F

Given subcutaneously under the skin, usually in the thigh on the day of vaccination and daily for the next 3 days.

Sargramostim

National Institutes of Health Clinical Center, 9000 Rockville Pike

U.T.M.D. Anderson Cancer Center

Docetaxel Alone or in Combination With Vaccine to Treat Breast Cancer

A Randomized Pilot Phase II Study of Docetaxel Alone or in Combination With PANVAC(Trademark)-V (Vaccinia) and PANVAC(Trademark)-F (Fowlpox) in Adults With Metastatic Breast Cancer

James Gulley, M.D.

Principal investigator

All cohorts receive the same intervention (Cohort 1: Colorectal arm, non-colorectal cancers; Cohort 2: breast cancer; Cohort 3: ovarian cancers)

Patients with histologically confirmed measurable or evaluable colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.

Colorectal Cancer Cohort

Patients with histologically confirmed measurable or evaluable metastatic non-colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.

Non-Colorectal Cancer Cohort

Patients with evaluable, metastatic breast cancer who have failed or not a candidate for standard therapy.

Breast Cohort

Patients with evaluable, metastatic ovarian cancer who have failed or not a candidate for standard therapy.

Ovarian Cohort

Race/Ethnicity, Customized

Grade 0 is normal activity. Fully active, able to carry on all pre-disease performance without restriction. Grade 1 is symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g. light housework, office work).

Number of Participants with Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0-1

Number of Participants with Prior Therapy

Number of Participants with a Primary Tumor

Response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response is disappearance of all clinical and laboratory signs and symptoms of disease for a minimum of 4 weeks during which no new lesions may appear. Partial Response is a minimum of 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. Stable disease is neither sufficient shrinkage to qualify for partial response nor progressive disease, taking as reference the smallest sum longest diameter since the treatment started. Progressive disease is a minimum of 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new measurable lesions.

Breast Cancer Cohort

Ovarian Cancer Cohort

Number of Participants With Complete Responses (CRs), Partial Responses (PRs,) Stable Disease and Progressive Disease in the Ovarian Cancer and Breast Cancer Cohorts

Grade 1 (mild) and Grade 2 (moderate) adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 if reported prior to August 1, 2010 and CTCAE v4.0 if reported after. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Patients with histologically confirmed measurable or evaluable metastatic colorectal cancer, non-colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.

Colorectal Cancer and Non-Colorectal Cancer Cohort

Percentage of Vaccines Associated With Grade 1 and Grade 2 Adverse Events Related to Vaccine in the Colorectal Cancer and Non-Colorectal Cancer Arm/Group

Vaccines were administered to participants and Grade 1 (mild) and Grade 2 (moderate) adverse events were assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 if reported prior to August 1, 2010 and CTCAE v4.0 if reported after. Common Terminology Criteria in Adverse Events. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Patients with evaluable, metastatic breast or ovarian cancer who have failed or not a candidate for standard therapy.

Breast Cancer and Ovarian Cancer Cohorts

Percentage of Participants With Grade 1 and Grade 2 Adverse Events Possibly, Likely, or Definitely Related to Vaccine in the Breast Cancer and Ovarian Cancer Cohorts

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 if reported prior to August 1, 2010 and CTCAE v4.0 if reported after. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Patients with histologically confirmed measurable or evaluable metastatic colorectal cancer, non-colorectal cancer, or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.

Patients with evaluable, metastatic breast cancer or ovarian cancer who have failed or not a candidate for standard therapy.

Breast Cancer and Ovarian Cancer Cohort

Number of Participants With Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE) v3.0 and v4.0

Immune response in human leukocyte antigens (HLA)-A2 positive patients to carcinoembryonic antigen (CEA) was assessed by enzyme-linked immunospot assay (ELISPOT) analysis. A positive immune response was defined as a >2x fold increase in the number of interferon gamma producing cells.

Patients with histologically confirmed measurable or evaluable metastatic colorectal cancer or patients with surgically resected metastatic disease at high risk for recurrence who had completed at least one 5-fluorouracil/(5-FU) containing chemotherapy regimen (e.g., 5-fluorouracil/leucovorin (5-FU/LV) with or without either irinotecan or oxaliplatin or patients that have had an elevated serum CEA (>5 ugg/L) at any point during their disease course who have failed or not a candidate for standard therapy.

Number of Participants With an Positive Immune Response to Carcinoembryonic Antigen (CEA) Peptide and/or Protein in the Colorectal Cancer and Non-colorectal Cancer Cohort Post Vaccination

Number of Participants With an Positive Immune Response to Carcinoembryonic Antigen (CEA) Peptide and/or Protein in the Breast Cancer and Ovarian Cancer Cohorts Post Vaccination

Overall Study

Dr. James Gulley

Colorectal Cancer vs Non-Colorectal Cancer Cohort

Breast and Ovarian Cohorts

Adenocarcinoma

Colorectal Cancer

Ovarian Cancer

Patients receive 2 x 10(8) pfu PANVAC-V (vaccinia) subcutaneously on Day 1.

Patients receive 1 x 10(9) pfu PANVAC-F (fowlpox) or about days 15, 29, and 43 then every month for 12 doses then every 3 months until disease progression or toxicity.

100g sargramostim will be given subcutaneously at the site of the vaccination on each vaccination day and for three consecutive days thereafter.

Sargramostim (GM-CSF, Leukine)

PANVAC-V and PANVAC-F Vaccines Plus Sargramostim to Treat Advanced Cancer

An Open Label Pilot Study to Evaluate the Safety and Tolerability of PANVAC-V (Vaccinia) and PANVAC-F (Fowlpox) in Combination With Sargramostim in Adults With Metastatic Carcinoma

mucin/breast neoplasms

Clinical Impact of EUS Elastography Mean Strain Histograms (SH) and Contrast Peak-enhancement in Focal Pancreatic Masses and Lymph Nodes

Biomarkers in Predicting Response in Patients With Early-Stage Non-Small Cell Lung Cancer Previously Treated With Adjuvant Chemotherapy

Docetaxel Alone or in Combination With Vaccine to Treat Breast Cancer

PANVAC-V and PANVAC-F Vaccines Plus Sargramostim to Treat Advanced Cancer

科学支持的最完整的草药数据库