Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Adenocarcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Immunologic Factors

Patients receive anti-PSMA monoclonal antibody MDX1201-A488 IV over 30 minutes on day 1 and undergo IOOI during RALP on day 3.

anti-PSMA monoclonal antibody MDX1201-A488

robot-assisted laparoscopic surgery

diffuse optical imaging

pharmacological study

Laboratory Biomarker

Questionnaire

Ali Zhumkhawala, MD

This pilot clinical trial studies the best dose of anti-prostate specific membrane antigen (PSMA) monoclonal antibody MDX1201-A488 (MDX1201-A488) given before surgery to aid in visualization of the prostate. Attaching a fluorescence, a substance that emits radiation that is visible, to the anti-PMSA antibody and injecting it into the body may help identify the tumor when specialized microscopes are used.

PRIMARY OBJECTIVES: I. Determine the preferred imaging dose (if any), based on image quality and correlation with pathological findings, of intravenously administered MDX1201-A488 in a dose-escalating study (doses of 5 and 15 mg) in patients with moderate to high-risk prostate cancer prior to undergoing robotic assisted laparoscopic prostatectomy (RALP), subject to predetermined safety stopping rules.

SECONDARY OBJECTIVES: I. Correlate intra-operative optical imaging (IOOI) findings with pre-operative magnetic resonance imaging (MRI) findings and clinical staging.

OUTLINE: This is a dose-escalation study. Patients receive anti-PSMA monoclonal antibody MDX1201-A488 intravenously (IV) over 30 minutes on day 1 and undergo IOOI during RALP on day 5.

After completion of study treatment, patients are followed up at 4-7 weeks, 3 months, 6 months, 9 months, and 1 year.

Intra-operative Optical Imaging With MDX1201-A488 in Patients With Prostate Cancer

Intra-operative Optical Imaging Utilizing Anti-PSMA (Prostate Specific Membrane Antigen) Fluorescent Antibody During Robotic Assisted Laparoscopic Prostatectomy

The main fluorescence metric will be the minimum fluorescence observed in 10 sampled high power fields from a single representative cancerous section taken per patient. Other metrics will be the mean fluorescence observed in the 10 sampled high power fields, and the median fluorescence observed. The minimum fluorescence is chosen based on the concept that the primary focus is on observing the fluorescence, and areas of peak fluorescence greatly influence the mean, and also have some influence on the median, yet may be of limited relevance.

National Cancer Institute (NCI)

City of Hope Medical Center

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Patients are followed up at 1, 2, 3, 4, and 5 years and undergo collection of sputum, nasal epithelium, buccal epithelium, blood, and urine samples. Patients also undergo pulmonary function tests, chest CT, and review of medical records

Biospecimen Collection

Biospecimen collection

Pulmonary Function Test

Computed Tomography (CT)

Eric Grogan, MD

This research trial studies the long term follow-up for early detection of lung cancer in current or former smokers. Following up on smokers by collecting and analyzing specimens in the laboratory, performing chest computed tomography (CT) scans, as well as reviewing medical records may help doctors detect lung cancer at an earlier stage.

PRIMARY OBJECTIVES:

I. To provide screening for lung cancer in an underserved and high risk population for lung cancer.

II. To collect clinical and demographic information and research bio specimens prospectively on high risk individuals.

III. To analyze the association between suspected lung cancer risk factors and outcomes such as pre-malignant lesions and diagnosis of lung cancer.

IV. To identify and validate biomarkers that are associated with lung cancer risk factors and premalignant lesions.

V. To assess the association between patient characteristics and test results to the genetic and histological characteristics of lung preinvasive lesions and cancers.

VI. To describe this high-risk cohort and to identify the patients eligible for future clinical trials (e.g. chemoprevention).

OUTLINE:

Patients are followed up at 1, 2, 3, 4, and 5 years and undergo collection of sputum, nasal epithelium, buccal epithelium, blood, and urine samples. Patients also undergo pulmonary function tests, chest CT, and review of medical records.

Sputum, nasal epithelium, buccal epithelium, blood, urine

Early Detection of Lung Cancer

Early Detection of Lung Cancer in the Medically Underserved Population

Will validate the performance of the candidate biomarkers of risk or of early diagnosis.

Vanderbilt-Ingram Cancer Center

Associate Professor of Thoracic Surgery

Skin and Connective Tissue Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

Carboplatin

Atezolizumab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Patients receive atezolizumab IV over 30-60 minutes and carboplatin IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients receive carboplatin as in Arm 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may cross-over to Arm 1 upon disease progression.

Quality-of-Life Assessment

This randomized phase II trial studies how well carboplatin with or without atezolizumab works in treating patients with stage IV triple negative breast cancer. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Giving carboplatin with atezolizumab may work better in treating patients with stage IV triple negative breast cancer

Primary objective:

To evaluate the efficacy, as measured by progression free survival (PFS) of carboplatin + atezolizumab (using irRECIST) versus carboplatin alone (using RECIST) in patients with triple negative metastatic breast cancer

Secondary objectives:

* To determine overall response rate.
* To evaluate the efficacy, as measured by clinical benefit rate, of carboplatin + atezolizumab (using irRECIST) versus carboplatin (using RECIST) alone in patients with triple negative metastatic breast cancer. Clinical benefit rate is defined as complete response plus partial response plus stable disease for 6 months.
* To determine the duration of response for patients achieving a partial or complete response.
* To evaluate the overall survival (OS) of carboplatin + atezolizumab versus carboplatin alone in patients with triple negative metastatic breast cancer.

TERTIARY OBJECTIVES:

* To perform the following correlative studies from biopsies taken at baseline:

  1. Tumor infiltrating lymphocyte frequency and phenotype (TILs) at baseline
  2. PD-L1 expression from the baseline pre-treatment tissue and at progression lesion, performed by IHC (SP142 clone)
  3. HER2 (IHC, FISH) and ER/PR levels (IHC) from a metastatic site
  4. Perform RNA-seq to determine non-synonymous mutation burden in expressed genes and gene expression to assign a triple negative subtype at baseline for correlations with clinic outcome
  5. Immune phenotyping (IHC) for markers of T cell subsets and activation (CD4, CD8, FoxP3, CD25, Glut1) and exhaustion (PD1, CTLA4) and test feasibility of flow cytometric analyses to include additional markers
* To assess the effect of BRCA mutations on response to the study drugs
* To evaluate the effect of steroids on the efficacy of atezolizumab To assess the prognostic effects of TILs on PFS and CBR in patients receiving atezolizumab

Carboplatin With or Without Atezolizumab in Treating Patients With Stage IV Triple Negative Breast Cancer

A Phase II Trial of Atezolizumab (Anti-PDL1) With Carboplatin in Patients With Metastatic Triple Negative Breast Cancer

Statistics will be primarily descriptive.

The PFS is defined as the time from the first day of treatment to the first observation of disease progression (RECIST V1.1) or death of any cause. Those without events were censored at the last follow up. The median PFS time will be estimated using the Kaplan-Meier method with 95% confidence intervals.

Patient response to treatment was evaluated by RECIST V1.1. The ORR (CR + PR) and corresponding 95% confidence intervals (exact) were estimated among evaluable patients.

Patient response to treatment was evaluated by RECIST 1.1. The CBR (CR + PR+stable disease ≥ 6 months) and corresponding 95% confidence intervals (exact) were estimated among evaluable patients.

DOR was defined as the time from CR or PR to progression using RECIST V1.1. The median DOR and corresponding 95% confidence intervals was estimated uisng Kaplan-Meier method.

OS is defined as the time from first day of treatment to death. Those alive were censored at the last follow up. The median and OS time and corresponding 95% confidence intervals were estimated using Kaplan-meier method.

Genentech, Inc.

Principal Investigator

Patients receive atezolizumab IV over 30-60 minutes and carboplatin IV on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Atezolizumab: Given by vein

Carboplatin: Given by vein

Laboratory Biomarker: Correlative study

Quality-of-Life Assessment: Ancillary studies

Arm 1 (Atezolizumab, Carboplatin)

Patients receive carboplatin as in Arm 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may cross-over to Arm 1 upon disease progression.

Carboplatin: Given by vein

Laboratory Biomarker: Correlative study

Quality-of-Life Assessment: Ancillary studies

Arm 2 (Carboplatin)

Patients on Arm 2 have the option to cross-over to Arm 1 upon disease progression and receive atezolizumab by IV over 30-60 minutes

Cross-Over

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Teresa Melton

Patients receive carboplatin as in Arm 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients may cross-over to Arm 1 upon disease progression.

Atezolizumab: Given by vein

Carboplatin: Given by vein

Laboratory Biomarker: Correlative study

Quality-of-Life Assessment: Ancillary studies

Progression Free Survival (PFS)

Randomized patients who received treatments and evaluated for response with evaluanble result.

Overall Response Rate (ORR)

Randomized patients who received treatment and evaluated response with evaluable result.

Clinical Benefit Rate (CBR)

Randomized patients who received treatment and had CR or PR.

Duration of Response (DOR)

Randomized patients who received treatment.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Intra-operative Optical Imaging With MDX1201-A488 in Patients With Prostate Cancer	NCT02048150	Adenocarcinoma ... Stage IIB Prost... Stage III Prost... Stage IV Prosta...	anti-PSMA monoc... robot-assisted ... diffuse optical... pharmacological... Laboratory Biom... Questionnaire	36 Years - 74 Years	City of Hope Medical Center
Early Detection of Lung Cancer	NCT03181256	Lung Cancer	Biospecimen Col... Biospecimen col... Biospecimen col... Biospecimen col... Biospecimen col... Pulmonary Funct... Computed Tomogr... Laboratory Biom...	55 Years - 80 Years	Vanderbilt-Ingram Cancer Center
Carboplatin With or Without Atezolizumab in Treating Patients With Stage IV Triple Negative Breast Cancer	NCT03206203	Triple Negative... Stage IV Breast... HER2 Negative Invasive Breast...	Atezolizumab Carboplatin Laboratory Biom... Quality-of-Life...	18 Years -	Vanderbilt-Ingram Cancer Center
Intra-operative Optical Imaging With MDX1201-A488 in Patients With Prostate Cancer	NCT02048150	Adenocarcinoma ... Stage IIB Prost... Stage III Prost... Stage IV Prosta...	anti-PSMA monoc... robot-assisted ... diffuse optical... pharmacological... Laboratory Biom... Questionnaire	36 Years - 74 Years	City of Hope Medical Center

Spots Global Cancer Trial Database for laboratory biomarker