Infections

All Conditions

Neoplasms

Digestive System Diseases

Virus Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Interferons

Antiviral Agents

Recombinant anti-tumor and anti-virus protein for injection, twice per week

Recombinant anti-tumor and anti-virus protein for injection, three times per week

High dose of recombinant anti-tumor and anti-virus protein for injection, three times per week

Recombinant anti-tumor and anti-virus protein for injection,10μg,im,twice per week for first 2 weeks, followed by 20μg, im, twice per week after 2 weeks

Recombinant anti-tumor and anti-virus protein for injection

Recombinant anti-tumor and anti-virus protein for injection, 10μg/1mL,im,three times per week for first 2 weeks, followed by 20μg,im, three times per week after 2 weeks.

Saline Injection, 1mL, im,three times per week

Saline Injection

Recombinant anti-tumor and anti-virus protein for injection, 10μg, im, three times per week for first week, followed by 20μg for two weeks, and followed by 30μg for a week, and followed a maintenance dose of 40μg, the frequency of administration is three times per week.

Xu jianming, M.D.

The purpose of this study is to evaluate the efficacy and safety of recombinant anti-tumor and anti-virus protein for injection in treating patients with metastatic colorectal cancer after failure of second-line and more than second-line treatment.

Explanation for study design

The trial including two stages. The first is an exploration stage to decide delivery frequency and dose of study drug. It is single-blinded, subjects will be randomly divided into 4 groups with a 2:2:2:1 ratio. Study drug given twice per week or 3 times per, dose of the drug are from 20μg to 40μg. The sample size is 105, duration is 12 to 18 months. Based on preliminary efficacy and safety, the better dosage regimen will decided for the second stage.The second stage is double-blinded,subject will be randomly divided into treatment group or placebo group with 2:1 ratio and sample size is 600.

Primary purpose

To compare overall survival between study drug and placebo groups .

Secondary purpose

1. Progression free survival were compared in both groups.
2. Disease control rate were compared in both groups.
3. Quality of life scores were compared in both groups.
4. Determine the safety and tolerance of recombinant anti-tumor and anti-virus protein for injection
5. Supplementary pharmacodynamics of recombinant anti-tumor and anti-virus protein for injection

Exploratory purpose Evaluate effects of recombinant anti-tumor and anti-virus protein for injection on the anti-tumor immunity, angiogenesis, apoptosis, cell proliferation, immune cells and cytokines levels.

Recombinant Anti-tumor and Anti-virus Protein for Injection in Treatment of Metastatic Colorectal Cancer

Phase II/III Study of Recombinant Anti-tumor and Anti-Virus Protein for Injection Compared With Placebo in Metastatic Colorectal Cancer After Failure of Second-Line and More Than Second-line Treatment

OS is defined as the length of time from random assignment to death or to last contact.

PFS is defined as the length of time from random assignment to disease progression or to death resulting from any cause other than the progress.

Quality of life is assessed using EORTC-C30 (the Quality of Life Questionnaire of the European Organisation for Research and Treatment of Cancer.)

AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v3.0.

As the drug concentration is very low, and no commercialized kits for original drug test, So original drug will not detect. Mopterin and MxA protein (alternate index) levels in serum will be used as alternative targets for pharmacodynamic studies

The disease control rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria)

Beijing Genova Biotech Company, Ltd.

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Musculoskeletal Diseases

Skin and Connective Tissue Diseases

Nervous System Diseases

Joint Diseases

Connective Tissue Diseases

Contracture

Fibroma

Dupuytren Contracture

Neoplasms by Histologic Type

Neoplasms, Connective and Soft Tissue

Neoplasms, Connective Tissue

Neoplasms, Fibrous Tissue

Muscular Diseases

Anti-Inflammatory Agents

Antiemetics

Neuroprotective Agents

Gastrointestinal Agents

Prednisolone

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Percutaneous needle fasciotomy with corticosteroid injection

Percutaneous needle fasciotomy with saline injection

Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre

Percutaneous needle fasciotomy

Corticosteroid injection

Saline injection

Laura H Matthiesen, MS, PhD-student

Jeppe Lange, MD, PhD

Laura H Matthiesen, PhD Student

Comparing percutaneous needle fasciotomy +/- corticosteroid injection for Dupuytren's contracture affecting metacarpophalangeal joints. A clinician-initiated, multicenter, randomized controlled trial.

Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture

Percutaneous Needle Fasciotomy (PNF) +/- Corticosteroid Injection for Dupuytren's Contracture (DC) Affecting Metacarpophalangeal Joints (MCP) . A Randomized Controlled Trial

Recurrence is defined as 20 degrees or more passive extension deficit in metacarpophalangeal joint from baseline

Regionshospitalet Silkeborg

Medical Student, PhD Student

Blood and Lymph Conditions

Symptoms and General Pathology

Breast Neoplasms

Lymphedema

Breast Cancer Lymphedema

Lymphatic Diseases

Postoperative Complications

Liposuction is performed on the abdomen or thighs.

Liposuction

30mL harvested lipoaspirate is injected at the affected axillary site.

Fat graft

30mL saline is injected at the affected axillary site.

Sham graf (Saline injection)

4mL stem cell suspension injected at the affected axillary site.

Stem cell injection

4mL saline injected at the affected axillary site.

Jens A Sørensen, MD, PhD

Breast cancer-related lymphedema is one of the most common and feared consequences of breast cancer treatment. Currently, lymphedema is primarily addressed conservatively with compression garments. Regenerative medicine may provide a new treatment option for lymphedema. This Phase 3 trial will examine the efficacy, effectiveness and safety of freshly isolated adipose-derived stromal cells administered in conjunction with a fat grafting procedure to the affected axillary region.

All patients undergo the same liposuction procedure. During general anesthesia, patients are randomized to either fat grafting or sham grafting with saline injection to the axilla. After stem cell suspension, patients receive either stem cell or saline injection depending on randomization using masked syringes.

Participants are blinded, care providers postoperatively are blinded, primary investigator is blinded and all outcome assessors are blinded. The surgeon performing the liposuction and the stem-cell staff are unblinded.

Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting

Assessed using clinical circumference measurement

Any side effects to treatments. Assessed by asking the patient at each visit.

Subjective change of lymphedema assessed by questionnaire. Range: 0-100. 100 being the most bothered.

Subjective change of lymphedema assessed by questionnaire. Range: 1-5. 5 being the most bothered

Subjective change of quality of life assessed by questionnaire. Range: 0-100. 0 being the most bothered.

Change in lymph drainage assessed by indocyanine-green lymphangiography

Change in use or type of conservative lymphedema treatments

Change in infection rates and sick-days due to lymphedema.

Change in L-DEX score of lymphedema arm derived from bioimpedance. Higher values mean more fluid in the lymphedema arm compared to the healthy arm.

Assessed using dual energy x-ray absorptiometry (DXA) scan. Change in values from baseline.

Odense University Hospital

Principal Investigator

Heart and Blood Diseases

Heart Arrest

Breast Diseases

Skin Diseases

Cisplatin

Vinblastine

Tubulin Modulators

Antimitotic Agents

Part I: Patients will receive up to 3 doses of INT230-6 injected weekly prior to breast surgery

Part II: Patients will receive up to 2 intratumoral doses of INT230-6 (over a 15-day period) prior to breast surgery

Part I: No intervention while awaiting surgery

Part II: Placebo saline injection

INT230-6 is a formulation of two well known chemotherapeutic agents, cisplatin (0.5mg/mL) and vinblastine sulfate (0.1mg/mL), combined with 2-hydroxybenzoylaminooctanoate (also known as SHAO-FA or SHAO as a sodium salt at 10mg/mL).

INT230-6

Angel Arnaout, MD

Arif Awan, MD

This is a phase II, randomized, multi-center, parallel design, window of opportunity trial evaluating intratumoral INT230-6 in up to 90 patients with early stage breast cancer. In a 2:1 randomization, patients on the treatment arm will receive intratumoral INT230-6 injections prior to breast surgery.

The study comprises 2 consecutive parts. The first part will be to test safety and feasibility of the dosing procedures. Results from Part I of the study will standardise the optimal dose and frequency of INT230-6 for participants in Part II.

Part I: Open-label 2:1 randomized study of up to 30 patients. Treatment arm patients will be given up to 3 doses of INT230-6 injected weekly prior to breast surgery, at a dose based on longest diameter. The control arm patients receive no treatment.

Part II: Double-blind, 2:1 randomized study of up to an additional 60 patients. The placebo arm includes a saline injection of similar dose and frequency as the treatment arm (up to 2 doses of INT230-6/saline injected weekly prior to breast surgery).

INVINCIBLE TRIAL: Intratumoral INT230-6 in Breast Cancer

A Phase II Randomized Window of Opportunity Trial Evaluating Clinical and Biological Effects of Intratumoral INT230-6 in Early Stage Breast Cancer: The INVINCIBLE Trial

Tumor's viable plus necrotic tissue, at the post-treatment specimen.

Assessed by the local pathologist at the time of definitive surgery in subjects with breast cancer

Comparison of pre (diagnostic biopsy) and post treatment (surgical resection) samples

overall safety of INT230-6 injected prior to surgery

Intensity Therapeutics, Inc.

Ontario Institute for Cancer Research

Ottawa Hospital Research Institute

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Lower Urinary Tract Symptoms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Urological Manifestations

Vasodilator Agents

Botulinum Toxins

Botulinum Toxins, Type A

abobotulinumtoxinA

Acetylcholine

Cholinergic Agents

Neurotransmitter Agents

Intraprostatic injection of Botox (100 units for \< 30 cc prostate; 200 units for \> 30 cc prostate) administering 2 transperineal injections into both lateral lobes of the prostate (25-50 units per injection), just 5-10 mm proximal to the bladder neck.

Botox injection

Saline injection, administering 2 transperineal injections into both lateral lobes of the prostate (1-2 cc per injection), just 5-10 mm proximal to the bladder neck.

Peter T Nieh, MD

The purpose of this study is to see if botox injection into the prostate during seed implantation (brachytherapy) for prostate cancer a) improves urinary symptoms or avoids need for urinary tract instrumentation over the 6-8 month post-operative period when one wants to avoid manipulating the radioactive seeds, and b) speeds up the drop in PSA. Patients will be randomized to botox vs saline injection, at the completion of the seed implantation procedure.

Brachytherapy is a popular treatment modality for localized prostate cancer, where radioactive seeds are implanted through 18 gauge needles into the prostate via a perineal template with rectal ultrasound guidance. The radioactivity is delivered over several months, depending on the isotope used. During this time, there can be exacerbation of urinary voiding symptoms from early edema of the prostate gland due to the implantation procedure, then later from the inflammatory reaction of the radiation. Because the initial acute inflammation may persist for many months despite steadily declining doses of radiation, attempts are made to minimize urinary symptoms prior to brachytherapy with pharmacologic therapy (alpha-blockers) or minimally invasive surgical therapy (transurethral incision or limited transurethral resection to avoid significant distortion of the prostate parenchyma for future seed implantation). Even with these precautions, around 30-40% of brachytherapy patients will still develop voiding symptoms. With such bothersome symptoms, intervention is deferred for at least 8-10 months to avoid distorting the planned field of radiation. Once symptoms develop, various additional pharmacologic measures are employed, such as increased doses of alpha-blockers, medrol steroid taper, and non-steroidal anti-inflammatory agents. Some patients require intermittent self-catheterization or suprapubic catheter for urinary diversion.

Botulinum toxin has been used for cosmetic uses, and has been successfully used for treatment of overactive bladder, external sphincter dyssynergia, and benign prostatic hyperplasia (BPH). The studies with BPH show reduction in symptoms scores, PSA, and prostate volume, the latter from atrophy due to the denervation effect. The response lasts for 6-9 months.

We propose to study botox intraprostatic injection during brachytherapy to see whether this improves urinary symptoms or avoids need for urinary tract instrumentation over this 6-8 month post-operative period when one wants to avoid manipulating the radioactive seeds. We will also monitor PSA, and see if there is any measurable augmentation of PSA decline with botox + Brachytherapy vs Brachytherapy alone. We will randomize patients to botox (100 units for \< 30 cc prostate; 200 units for \> 30 cc prostate) vs saline injection, administering 2 transperineal injections into both lateral lobes of the prostate (25-50 mg per injection), just 5-10 mm proximal to the bladder neck.

Study design:

N= 60 (30 receive Botox, 30 receive saline)

Followup:

AUA Symptoms scores weekly for 4 weeks, monthly thereafter Medications for urinary symptoms Need for catheterization PSA checked at 1 mo, 3 mo, 6 mo, 9 mo, 1 year, 15 mo, 18 mo, 24 mo

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Recombinant Anti-tumor and Anti-virus Protein for Injection in Treatment of Metastatic Colorectal Cancer	NCT01386242	Metastatic Colo...	Recombinant ant... Recombinant ant... Saline Injectio... Recombinant ant...	18 Years -	The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture	NCT05440240	Dupuytren Contr... Dupuytren's Dis... Contracture Joint Diseases Musculoskeletal... Fibroma Neoplasm, Fibro... Neoplasms, Conn... Neoplasms, Conn... Neoplasms by Hi... Neoplasms Connective Tiss...	Percutaneous ne... Corticosteroid ... Saline injectio...	45 Years - 99 Years	Regionshospitalet Silkeborg
Recombinant Anti-tumor and Anti-virus Protein for Injection in Treatment of Metastatic Colorectal Cancer	NCT01386242	Metastatic Colo...	Recombinant ant... Recombinant ant... Saline Injectio... Recombinant ant...	18 Years -	The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture	NCT05440240	Dupuytren Contr... Dupuytren's Dis... Contracture Joint Diseases Musculoskeletal... Fibroma Neoplasm, Fibro... Neoplasms, Conn... Neoplasms, Conn... Neoplasms by Hi... Neoplasms Connective Tiss...	Percutaneous ne... Corticosteroid ... Saline injectio...	45 Years - 99 Years	Regionshospitalet Silkeborg
Treatment of Breast Cancer-related Lymphedema With Stem Cells and Fat Grafting	NCT03776721	Lymphedema	Liposuction Fat graft Sham graf (Sali... Stem cell injec... Saline injectio...	18 Years -	Odense University Hospital
Percutaneous Needle Fasciotomy +/- Corticosteroid Injection for Dupuytren's Contracture	NCT05440240	Dupuytren Contr... Dupuytren's Dis... Contracture Joint Diseases Musculoskeletal... Fibroma Neoplasm, Fibro... Neoplasms, Conn... Neoplasms, Conn... Neoplasms by Hi... Neoplasms Connective Tiss...	Percutaneous ne... Corticosteroid ... Saline injectio...	45 Years - 99 Years	Regionshospitalet Silkeborg
INVINCIBLE TRIAL: Intratumoral INT230-6 in Breast Cancer	NCT04781725	Breast Cancer	INT230-6 Saline injectio...	-	Ottawa Hospital Research Institute
Botulinum Toxin Injection With Prostate Brachytherapy	NCT00681148	Prostate Cancer Lower Urinary T... Radioactive See...	Botox injection Saline injectio...	18 Years -	Emory University

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