Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Transitional Cell Carcinoma

Urethral Cancer

All Drugs and Chemicals

Vaccines

Immunomodulating Agents

Subjects received infusion of DN24-02, at 2-week intervals, for a total of 3 infusions.

Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.

DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.

DN24-02

Observation only until documentation of disease recurrence.

Standard of Care

Robert Israel, MD

This study was conducted to examine survival, disease-free survival, safety, and the magnitude of the immune response induced following administration of DN24-02 in subjects with HER2+ urothelial carcinoma.

Multicenter, open-label, Phase 2 study. Subjects were randomized to either the investigational product, DN24-02, or to standard of care. Subjects randomized to the experimental arm received DN24-02 at 2-week intervals, for a total of 3 infusions. The study evaluated survival, disease-free survival, safety and the magnitude of the immune response between these 2 subject groups.

DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma

A Randomized, Phase 2, Open-label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma

Overall survival is defined as the time from randomization to death due to any cause.

\*This study was terminated early due to administrative reasons.

Dendreon

Adverse events are reported in the safety population. The safety population was defined as all subjects in the treatment arm who underwent at least 1 leukapheresis and all randomized control subjects with at least 1 post-baseline safety assessment or visit.

Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin-containing chemotherapy is beneficial in the adjuvant setting for this patient population.

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Baseline weight for one subject in standard of care group is missing.

Body weight

ECOG 0=Fully Active; No restrictions

ECOG 1= Restricted Strenuous Activity

ECOG 2=Ambulatory, capable of self-care; no work

ECOG Performance Status is a method used to assess the functional status of a patient. The scale ranges from 0-5. 0=Fully active, able to carry on all pre-disease performance without restriction; 1=Restricted in physically strenuous activity but ambulatory and able to carry out light or sedentary work; 2=Ambulatory, capable of all self-care but unable to carry out work activities. Up and about \>50% of waking hour; 3=Capable of limited self-care, confined to bed or chair \>50% of waking hours; 4=Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5=Dead

Baseline ECOG data is missing for one subject in each group.

Eastern Cooperative Oncology Group (ECOG) Performance Status

Shabnam Vaziri

Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.

Standard of Care: Standard of care

Intent to Treat (ITT) population.

\*This study was terminated early due to administrative reasons.

Overall Survival

Overall Study

Urinary Bladder Diseases

Ureteral Diseases

Ureteral Neoplasms

Pelvic Neoplasms

Urethral Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Male Urogenital Diseases

Urethral Diseases

Antineoplastic Agents

Gemcitabine

Cisplatin

Antimetabolites

Dose Escalation: Begin with Level 1 dose of enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).

Dose Expansion: Enzalutamide at recommended dose level with standard doses of cisplatin and gemcitabine.

Enzalutamide orally once a day. Dose Escalation Level 1: 80 mg; Level 2: 160 mg. Dose Expansion at recommended dose level, after dose escalation.

Enzalutamide

Cisplatin at 70 mg/m\^2 IV on day 1, repeated every 21 days for total of 6 cycles.

Gemcitabine at 1000 mg/m\^2 IV on days 1, 8, repeated every 21 days for total of 6 cycles.

Jingsong Zhang, M.D., Ph.D.

Shilpa Gupta, M.D.

The main purpose of this study is to find out the dose of enzalutamide that can be safely given with gemcitabine and cisplatin in patients with advanced bladder cancer. Researchers also want to find out the side effects of these drugs when given together. This study will also help in finding out the effect on tumor of the combination of enzalutamide, gemcitabine and cisplatin.

For the phase 1 dose escalation phase, the starting dose of enzalutamide will be 80 mg orally once a day (Level 1). The dosing regimen of cisplatin and gemcitabine will be at standard doses of Gemcitabine at 1000 mg/m\^2 IV on days 1, 8 and cisplatin at 70 mg/m2 IV on day 1, repeated every 21 days for total of 6 cycles.

Three patients will be treated dose level 1 (enzalutamide 80 mg daily). If 0 patients experience dose limiting toxicity (DLT), dose escalation will be done to level 2 of enzalutamide 160 mg daily. If 1 patient experiences DLT, 3 more patients will be treated at the same dose level; if 1 of 6 experiences DLT, escalate the dose to next level, and if 2 or more of 6 experiences DLT, the dose level 1 (80 mg enzalutamide) will be the recommended dose for dose expansion cohort.

The cohort expansion will then be done by enrolling 12 patients with stage IV bladder cancer, who express androgen receptor (AR) staining of 1+ and above by immunohistochemistry (IHC), to determine the safety and tolerability of cisplatin and gemcitabine with the recommended dose level of enzalutamide (80 mg or 160 mg, depending upon the safety results from dose escalation part) in this expanded cohort of patients with AR + bladder cancer.

Enzalutamide would be continued after completion of 6 cycles of gemcitabine-cisplatin for patients exhibiting a response or stable disease, until they experience disease progression.

Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer

A Phase I/1b Study of Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer

Dose Escalation. Maximum Tolerated Dose (MTD) of Enzalutamide when given with Cisplatin and Gemcitabine at standard doses. Dose Level 1: 80 mg Enzalutamide; Dose Level 2: 160 mg Enzalutamide.

Dose-Limiting Toxicity (DLT) is defined as any of the following occurring in the first 21 days (cycle 1) of study participation that are considered at least possibly related to enzalutamide administration. Toxicities that are in the opinion of the investigator(s) attributable exclusively to gemcitabine or cisplatin will not be considered DLT.

* 7 consecutive missed doses (out of 21 doses) of enzalutamide in 21 days due to study drug related toxicity.
* Missed day 8 dose of gemcitabine in cycle 1 will not be considered DLT.
* Delay of greater than 3 weeks from scheduled date in initiating cycle 2 due to study drug related toxicity.
* Discontinuation of a patient due to study drug related toxicity before completing cycle 1.

Dose Expansion. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Dose Expansion. PFS is defined as the time from randomization until objective tumor progression or death. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).

Dose Expansion. Overall survival is defined as the time from randomization until death from any cause, and is measured in the intent-to-treat population.

H. Lee Moffitt Cancer Center and Research Institute

Patient deaths listed in "all cause mortality" occurred after the Adverse Event reporting period, but within the Overall Survival follow-up period.

Dose Escalation: Level 1 dose of 80 mg enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).

Dose Escalation: Dose Level 1

Dose Escalation: Level 2 dose of 160 mg enzalutamide (orally), with standard doses of cisplatin and gemcitabine via intravenous (IV).

Dose Escalation: Level 2 Dose

Dose Expansion: Enzalutamide at MTD (160 mg) with standard doses of cisplatin and gemcitabine.

Dose Expansion

Dose Escalation: Level 1 Dose

White Non-Hispanic

Black or African American

Asian

Hispanic or Latino

Other

Race/Ethnicity, Customized

This study did not meet the anticipated accrual goal of 24 participants.

Dr. Jingsong Zhang

Dose Escalation

Recommended Dose of Enzalutamide

Partial Response

Progressive Disease

Stable Disease

Complete Response

Not Evaluable

Dose Escalation - Level 2 dose of 160 mg enzalutamide (orally) with standard dose of cisplatin and gemcitabine via intravenous (IV).

All participants evaluable at time of analysis.

Overall Response Rate (ORR): Complete Response (CR) + Partial Response (PR)

Progression Free Survival (PFS)

Dose Escalation: Level 2 dose of 160 mg enzalutamide (orally) with standard dose of cisplatin and gemcitabine via intravenous (IV).

Overall Survival (OS)

Dose Escalation- Level 2 Dose

Enzalutamide at MTD (160 mg) with standard doses of cisplatin and gemcitabine.

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Central Nervous System Depressants

Anti-Infective Agents

Anesthetics

Ciprofloxacin

All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy.

The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection.

UreScan

Thomas E Ahlering, MD

This study is being performed to verify the ability to use minimally invasive transurethral ultrasonic imaging technology for the purpose of identifying prostate cancer. Transurethral ultrasonic prostate imaging, may in the future, be used for detection and monitoring these disease processes to minimize the need for obtaining surgical biopsy specimens. The hypothesis is that tissue-density variations, as revealed in diagnostic ultrasonic imaging, results in unique image signatures for identification of prostate cancer. This imaging procedure provides a multifaceted view of the entire in-situ gland.

The current use of Prostate Specific Antigen (PSA) for determining the likelihood of presence of cancer in the prostate gland requires interpretation and has a good but limited to predict prostate cancer on biopsy, with significant false prediction rates. More importantly as a blood test, the PSA test lacks the ability to pinpoint the location of the cancer within the prostate gland. Preliminary study findings have suggested that "Transurethral Ultrasonic Scanning" (TUUS) presents the desired improved diagnostic sensitivity for detection of cancer within the imaged prostate gland, and has the intrinsic capability to provide high resolution images of the transverse and future three-dimensional views of the entire gland better than currently used Transurethral Ultrasound (TRUS). Two important goals of the practicality of this minimally invasive technology will be assessed by this study. 1. The ability of TUUS to directly detect prostate cancer locations in the prostate. 2. The use of TUUS to successfully guide the prostate needle biopsy to cancer loci with a high rate accuracy.

The Purpose of the Research The primary objective of this Institutional Review Board-controlled study is to determine if the presently manually-read results of TUUS data obtained with the novel UreScan device can be correlated with pathologist findings in a harvested prostate gland from an individual with diagnosed prostate disease. If successful, a future Institutional Review Board study will explore the use of computer software to examine the 256 transverse image slices of a large number of prostate cancer patients to establish the clinical applicability of TUUS for screening and assessment of individuals with elevated levels of PSA and/or positive digital rectal examinations (DRE), potentially reducing the number of future biopsy examinations with false-positive findings.

Background Information The current use of Prostate Specific Antigen for determining the likelihood of presence of cancer in the prostate gland has been shown to be seriously flawed. Multiple studies reviewing the findings of referred biopsies, based on elevated PSA levels, resulted in as many as 70% false positive findings for cancer. Improved rapid, minimally-invasive, low-cost methodology and technology should be developed to provide diagnostic cancer findings that have higher sensitivity and specificity is the objective goal of the present research. Preliminary study findings have suggested that "Transurethral Ultrasonic Scanning" (TUUS) presents the desired improved diagnostic sensitivity for detection of cancer within the imaged prostate gland and has the intrinsic capability to provide high resolution images of the transverse and future three-dimensional views of the entire gland. Two important goals of this minimally invasive technology will be assessed by this study. 1. The ability of TUUS to directly detect prostate cancer in situ in the prostate. 2. The use of TUUS to successfully guide the prostate needle biopsy to cancer loci with a high rate accuracy.

In a 2003 study by Holmes et al, the TUUS device was tested on 2 patients who had seeds implanted for prostate cancer. TUUS revealed more seeds (82%, 84%) than standard TRUS (63%, 65%) in the 2 patients. These simple cases demonstrated the feasibility of providing transverse images of the entire prostate gland. Holmes postulated that this procedure would have to be automated to achieve any clinical utility value and the project essentially was abandoned by Mayo.

The TUUS/"UreScan" system is a marriage of an off label usage of the FDA approved vascular probe, placed inside a standard foley catheter which is inserted into the penis onto the prostate to the neck of the bladder. The ultrasound probe travels the length of the prostate (\~4-8cm) within the sheath of the catheter and images the entire prostate with ultrasound. The travel of the ultrasound probe is controlled by a small motor which is driven from outside the catheter and patient as well. This motor driven probe offers the possibility of accurate and reproducible ultrasounds of the prostate, as the patient's prostate apex is used the anchor point for study.

Refinements to the TUUS system include:

1. A Foley type introducer should be used for placing the intravascular ultrasound transducer in the prostatic urethral region to be imaged
2. Use of a fixed-position, ultrasonic coupling gel-coated Introducer to eliminate the possibility of urethral abrasion or trauma as might otherwise occur without the Introducer when moving the transducer within the prostatic imaging region.
3. Insertion into the Introducer of the wire-rotationally-driven ultrasonic transducer as coated with sterile water ultrasonic coupling between the transducer and introducer
4. The examiner would then initiate the automated scanning procedure with analog/digital video data for each of 256 transverse axial image slices of the prostate gland. The scanning of the gland can be stopped or started at the election of the examiner
5. A video-media record of the images derived from the procedure is available to an experienced reader for interpretation.

The initial UreScan hydrophone verified specifications included: 1. 256 transverse, automatically axially advanced, image slices. 2. Approximately 267 megabits of video data. 3. Diagnostic ultrasound scanning of 100 revolutions per minute at 9.0 M Megahertz. 4. Radial penetration of 6 cm. The scanner features:

1. The amplitude of reflected ultrasonic echoes from biological tissue, as displayed by a density-based oscillogram is directly proportional to the density of the tissue being insonated in an adjusted flat far-gain ultrasonic system.
2. Longitudinal time-related, ultrasonic densitometry and image-registered comparisons of sonograms have demonstrated progression and/or regression of disease consistent with efficacy of treatment procedures. This facilitates future "wait and watch surveillance" of known or suspected lesions while potentially minimizing and/or eliminating unnecessary surgical biopsy tissues procedures
3. The reflected echo waveform and sonogram has been shown to be unique for each type of disease entity. In prostate disease, there is a unique difference between the image-markers for prostate cancer and normal tissue.

The present study protocol is to determine if image-markers for cancer and other unique prostate pathology can be specifically identified. Further clinical studies will be required to determine sensitivity, specificity, accuracy and (+/-) predictor values of this procedure. Additional studies will be required to determine if the amplitude of the image-markers could be used for determining the approximate stage of the image detected disease processes.

Transurethral Ultrasonic Imaging For Detection and Classification of Prostate Cancer

The primary objective of this Institutional Review Board -controlled study is to determine if Trans urethral ultrasound can be used to identify prostate cancer, thus avoiding prostate needle biopsies for diagnosis

University of California, Irvine

Vice Chairman and Professor

All patients in the study will receive a scan of their prostate with the novel UreScan machine. All scans will be evaluated in their accuracy of detecting cancer loci within the prostate as compared to histopathological reviews of the prostate post robotic prostatectomy.

UreScan: The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection.

All Patients

Thomas Ahlering, MD

Data were not collected because the study was discontinued due to lack of feasibility and negative results.

Measure Novel Transurethral Ultrasound Signatures to Detect Prostate Cancer

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Adenocarcinoma

Stomach Neoplasms

Breast Neoplasms

Triple Negative Breast Neoplasms

Esophageal Neoplasms

Carcinoma, Hepatocellular

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Thyroid Neoplasms

Thyroid Diseases

Carcinoma, Renal Cell

Head and Neck Neoplasms

Endometrial Neoplasms

Genital Diseases, Female

Genital Neoplasms, Female

Kidney Neoplasms

Kidney Diseases

Uterine Neoplasms

Uterine Diseases

Breast Diseases

Skin Diseases

Stomach Cancer

Esophageal Cancer

Ovarian Cancer

Ovarian Epithelial Cancer

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Hematinics

Micronutrients

Irinotecan

Immune Checkpoint Inhibitors

Docetaxel

Abiraterone Acetate

Oxaliplatin

Atezolizumab

Liver Extracts

Iodine

Cadexomer iodine

Antineoplastic Agents, Immunological

Subjects will accrue in cohorts of 3-6 subjects for evaluation of cabozantinib tablet dose of either 20 mg, 40 mg, and 60 mg orally qd in combination with standard dosing regimen of atezolizumab (1200 mg infusion q3w). A standard "3 plus 3" design will be utilized to determine a recommended combination dosing regimen for the Expansion Stage.

RCC subjects with clear cell histology who have not received prior systemic anticancer therapy.

UC subjects (including bladder, renal pelvis, ureter, urethra) who have progressed on or after platinum-containing chemotherapy.

UC subjects (including bladder, renal pelvis, ureter, urethra) who are ineligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy.

UC subjects (including bladder, renal pelvis, ureter, urethra) eligible for cisplatin-based chemotherapy and have not received prior systemic chemotherapy.

UC subjects (including renal pelvis, ureter, urinary bladder, urethra) who have radiographically progressed on or after one prior immune check-point inhibitor (ICI) (anti-PD1 or anti-PD-L1) therapy.

CRPC subjects who have radiographically progressed in soft tissue on or after enzalutamide and/or abiraterone acetate for metastatic disease.

Stage IV non-squamous NSCLC subjects who have radiographically progressed on or after treatment with one prior immune checkpoint inhibitor (ICI) (anti-PD-1 or anti-PD-L1) therapy.

Stage IV non-squamous NSCLC subjects with positive PD-L1 expression and without prior systemic anticancer therapy.

Stage IV nonsquamous NSCLC subjects with sensitizing EGFR mutation who have radiographically progressed during or following prior treatment with an EGFR-targeting TKI. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.

RCC subjects with non-clear cell histology who have had up to one prior VEGFR-targeting TKI therapy.

TNBC subjects who have radiographically progressed during or following treatment with at least one prior systemic anticancer therapy. Prior treatment with ICIs (anti-PD1 or anti-PD-L1) is allowed if given in combination with chemotherapy.

OC subjects (including primary peritoneal cancer and fallopian tube cancer) who have platinum-resistant or refractory disease who have had up to two lines of prior systemic anticancer therapy.

EC subjects (serous or endometrioid histology) who have radiographically progressed during or following treatment with at least one prior systemic anticancer therapy.

HCC subjects (Child-Pugh score A) who have not received prior systemic anticancer therapy.

GC/GEJC/LEC subjects who have radiographically progressed during or following platinum-containing or fluoropyrimidine-containing chemotherapy.

CRC subjects who have radiographically progressed during or following systemic chemotherapy that contained fluoropyrimidine in combination with oxaliplatin or irinotecan.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma	NCT01353222	Urothelial Carc...	DN24-02 Standard of Car...	18 Years -	Dendreon
Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer	NCT02300610	Bladder Cancer Carcinoma, Tran... Renal Pelvis Ca... Ureter Cancer Urethra Cancer	Enzalutamide Cisplatin Gemcitabine	18 Years -	H. Lee Moffitt Cancer Center and Research Institute
Transurethral Ultrasonic Imaging For Detection and Classification of Prostate Cancer	NCT02307552	Prostate Cancer	UreScan	40 Years - 80 Years	University of California, Irvine
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors	NCT03170960	Urothelial Carc... Renal Cell Carc... Non-Small Cell ... Castration-resi... Triple Negative... Ovarian Cancer Endometrial Can... Hepatocellular ... Gastric Cancer Gastroesophagea... Colorectal Canc... Head and Neck C... Differentiated ... Lower Esophagea...	cabozantinib atezolizumab cabozantinib cabozantinib	18 Years -	Exelixis
DN24-02 as Adjuvant Therapy in Subjects With High Risk HER2+ Urothelial Carcinoma	NCT01353222	Urothelial Carc...	DN24-02 Standard of Car...	18 Years -	Dendreon
A Phase I/II Trial of AEZS-108 in Urothelial Cancer Patients Who Failed Platinum-chemotherapy	NCT01234519	Urothelial Carc...	AEZS-108 AEZS-108 at MTD	18 Years -	AEterna Zentaris
Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer	NCT02300610	Bladder Cancer Carcinoma, Tran... Renal Pelvis Ca... Ureter Cancer Urethra Cancer	Enzalutamide Cisplatin Gemcitabine	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for urethra

Every month we try and update this database with for urethra cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for urethra

Every month we try and update this database with for urethra cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for urethra cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.