Infections

All Conditions

Symptoms and General Pathology

Communicable Diseases

Epstein-Barr Virus Infections

Virus Diseases

Disease Attributes

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Burkhard Toenshoff, MD, PhD

Question:

In which stage of an EBV-infection is a selective reduction of immunosuppressive medication reasonable to minimize the risk for PTLD, without putting the transplant recipient at risk of acute rejection episodes due to under immunosuppression?

Aim of study:

Identification of patients at high-risk for PTLD.

PTLD represents a heterogeneous group of abnormal lymphoid proliferations, generally of B-cells, that occur in the setting of ineffective T-cell function because of pharmacological immunosuppression. Because the vast majority of PTLDs are associated with Epstein-Barr virus (EBV) infection, surveillance of EBV infection may have the potential to prevent the development of PTLD by early intervention. However, the cut-off values of "high" EBV viral load remain badly defined due to a lack of prospective studies and assay standardization. The aim of this ongoing multicenter prospective study is the serial detection of primary EBV infection or reactivation in a homogeneous patient population of pediatric renal transplant recipients during the first 2 years posttransplant by the combined analysis of quantitative EBV viral load by a standardized quantitative PCR technique, EBV serology and EBV-specific T-lymphocytes for the identification of high-risk patients.

EDTA plasma for EB viral load, serum for differentiated serology and sodium heparine whole-blood for EBV-specific t cells

EBV Infection as a Risk Factor for PTLD in Pediatric and Adult Renal Transplant Recipients

Surveillance of EBV Infection as a Risk Factor for PTLD in Pediatric and Adult Renal Transplant Recipients - a Multicenter Prospective Study

Klinik für Kinder- und Jugendmedizin

EBV in pediatric RTx patients

Nervous System Diseases

Cancer Pain

Pain

Pain, Intractable

Neurologic Manifestations

Epidural injection of 1.5mL/min RTX under the guidance of epidurogram.

single dose (0.4, 1, 2, 4, 8,15, 25 or 35 mcg), epidural injection

Resiniferatoxin

Monica Luchi, MD

The study is a multicenter, open-label Phase 1b single dose escalation safety study for adult subjects with intractable pain associated with cancer in any area below the mid-thoracic level who meet all other eligibility criteria.

All subjects who received RTX will be included in the analyses and summaries of safety, efficacy, PD, and PK assessments.

The design uses a traditional "3+3" rule-based design that does not stipulate any prior assumption of the dose-toxicity curve. Dose escalation is permitted between successive cohorts based upon a specified algorithm, using discrete dosage steps.

Study to Evaluate Safety and MTD of Epidural Resiniferatoxin Injection for Treatment of Intractable Cancer Pain

A Multicenter, Open-Label, Phase 1b Study to Assess the Safety and Define the Maximally Tolerated Dose of Epidural Resiniferatoxin Injection for the Treatment of Intractable Pain Associated With Cancer

Consumption of analgesics compared to baseline

Quality of life compared to baseline by the total score

Patient-reported rating of improvement on a 7-point scale, ranking the improvement from (1) to (7), with (1) being no change or worse to (7) being a great deal better and a considerable improvement that has made all the difference.

A 11-point scale for rating average and worst pain at the location intended to be treated with RTX within 12 hours of the clinical visit, with 0 being no pain to 10 being worst pain imaginable.

Quality of life affected by pain at the location intended to be treated with RTX, each question rates pain level and pain interference on a 0 to 10 scale. For pain level questions, 0 represents no pain and 10 represents pain as bad as can be imagined. For pain interference questions, 0 is "does not interfere" and 10 is "completely interferes".

Grade 3 or 4 Toxicity associated with RTX administration

Maximum dose without a Grade 3 or 4 toxicity

Daily average pain and daily worst pain on a 0-10 scale

Sorrento Therapeutics, Inc.

Pharmaceutical Solutions

All Drugs and Chemicals

15 mcg, 20 mcg, or 25 mcg in 2mL injected once into the epidural space

2mL injected once into the epidural space

Resiniferatoxin is a compound purified from natural sources

Placebo

Mike Royal, MD

This Phase 2 study assesses the safety and efficacy of a single injection of Resiniferatoxin versus placebo for the treatment of intractable advanced cancer pain.

This is a global multicenter, randomized Phase 2 study for subjects with advanced cancer experiencing intractable pain to assess the safety and efficacy of a single epidural injection of Resiniferatoxin versus vehicle control. Additional subjects who elect to not enroll but are willing to be followed will comprise a Concurrent Control Group. Subjects will be followed for twelve months.

Study to Assess Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer

A Multicenter, Phase 2 Study to Assess the Safety and Efficacy of Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer

To assess the safety of epidural RTX including incidence and severity of any short-term and long-term treatment-emergent adverse events (TEAEs) using the Common Terminology Criteria for Adverse Events (CTCAE) criteria

To assess efficacy of each epidural RTX dose in comparison to control groups on the subject's intractable pain due to advanced cancer using the Brief Pain Inventory, Short Form (BPI-SF) score (1-10, with 10 associated with worse pain)

To assess the efficacy of each epidural RTX dose in comparison to control groups on the quality of life using Treatment Helpfulness Questionnaire score (graded 1-7, with 7 being most helpful)

To assess the effect of each epidural RTX dose on opioid consumption, measuring the average reduction compared to baseline of daily opioid consumption, calculated as an oral morphine equivalent dose

Single dose of Resiniferatoxin (25 mcg in 3 mL) injected epidurally

Standard of care treatment as determined by the investigator

Resiniferatoxin is a TRPV-1 agonist which works by specifically ablating nociceptive nerve fibers.

Standard of care for intractable pain with the exception of intra-thecal pump placement as determined by the investigator.

Standard of Care

This is a Phase 3 study to assess the safety and efficacy of a single epidural administration of Resiniferatoxin versus standard of care for the treatment of intractable pain associated with cancer.

This study is a multicenter, randomized Phase 3 study to assess the safety and efficacy of a single epidural administration of Resiniferatoxin versus standard of care (SOC) for the treatment of intractable pain associated with cancer. Subjects will be followed for 12 weeks after treatment.

Follow-up visit examinations will be performed by a blinded outcomes assessor.

Phase 3 Study to Assess Resiniferatoxin vs Standard of Care for the Treatment of Intractable Cancer Pain

A Multicenter, Randomized, 2-Arm, Phase 3 Study to Assess the Efficacy and Safety of a Single Epidural Administration of Resiniferatoxin Versus Standard of Care (SoC) for the Treatment of Intractable Pain Associated With Cancer

Change from baseline to Week 4 in the intensity of worst pain over the previous 24 hours in the area targeted for treatment as measured by the 11-point NPRS (0-10 where 0 is no pain and 10 is worst pain imaginable)

Change from baseline to Weeks 8 and 12 in the intensity of worst pain over the previous 24 hours in the area targeted for treatment as measured by the 11-point NPRS (0-10 where 0 is no pain and 10 is worst pain imaginable)

AUC calculated on change from baseline through Week 4 in worst pain in the target pain location over the previous 24 hours, using the NPRS (0-10)

Incidence and severity of AEs assessed using the Common Terminology Criteria for Adverse Events (CTCAE) criteria

Change in Quality of Life from baseline to week 4 based on total score from the BPI-SF, modified to record the target pain treated with study drug

Duration of response defined as time from ≥20% decrease from baseline in worst pain score in the target pain location to ≥20% increase from the nadir of the worst pain score

Change from baseline to Week 4 in the intensity of average pain over the previous 24 hours in the target pain location as measured by the NPRS (0-10)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
EBV Infection as a Risk Factor for PTLD in Pediatric and Adult Renal Transplant Recipients	NCT00963248	Epstein-Barr Vi...		-	Klinik für Kinder- und Jugendmedizin
Study to Evaluate Safety and MTD of Epidural Resiniferatoxin Injection for Treatment of Intractable Cancer Pain	NCT03226574	Intractable Can...	Resiniferatoxin	18 Years -	Sorrento Therapeutics, Inc.
Study to Assess Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer	NCT05067257	Pain, Intractab... Pain Cancer Pain	Resiniferatoxin Placebo	18 Years -	Sorrento Therapeutics, Inc.
Study to Evaluate Safety and MTD of Epidural Resiniferatoxin Injection for Treatment of Intractable Cancer Pain	NCT03226574	Intractable Can...	Resiniferatoxin	18 Years -	Sorrento Therapeutics, Inc.
Study to Assess Epidural Resiniferatoxin for the Treatment of Intractable Pain Associated With Advanced Cancer	NCT05067257	Pain, Intractab... Pain Cancer Pain	Resiniferatoxin Placebo	18 Years -	Sorrento Therapeutics, Inc.
Phase 3 Study to Assess Resiniferatoxin vs Standard of Care for the Treatment of Intractable Cancer Pain	NCT04572776	Pain, Intractab... Pain Cancer	Resiniferatoxin Standard of Car...	18 Years -	Sorrento Therapeutics, Inc.
EBV Infection as a Risk Factor for PTLD in Pediatric and Adult Renal Transplant Recipients	NCT00963248	Epstein-Barr Vi...		-	Klinik für Kinder- und Jugendmedizin

Spots Global Cancer Trial Database for rtx

Every month we try and update this database with for rtx 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 rtx

Every month we try and update this database with for rtx 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 rtx 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.