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Modified Virus Therapy +/− Ruxolitinib for Endometrial Cancer
Study Summary
This trial is testing a modified virus that only infects cancer cells, with or without a drug that inhibits cancer cell growth. The goal is to find the best dose with the least side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 1 & 2 trial • 24 Patients • NCT03010358Trial Design
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Who is running the clinical trial?
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- I have not had external beam radiotherapy in the last 4 weeks.I have brain metastases that are either untreated or causing symptoms.Your platelet count is at least 100,000 per microliter within the past 14 days.Your AST and ALT levels are not more than twice the upper limit of normal.You are expected to live at least 12 more weeks.I have not had immunotherapy in the last 4 weeks.Your disease can be measured using specific guidelines for evaluating tumors.My largest tumor is 5 cm or smaller.You have been around a household member who is less than 15 months old or has a weakened immune system.Any other health issues that the main doctor thinks might make the treatment unsafe for you.You need to have a confirmation that the tumor is cancerous.I am willing and able to undergo treatment aimed at curing my disease.I do not have active or latent tuberculosis or hepatitis.I have not had chemotherapy in the last 4 weeks.I have an active brain disorder or seizures.I am HIV positive or have a weakened immune system.My endometrial cancer is at an advanced stage or has come back.I am not taking any corticosteroids except for creams or inhalers.I have not received a live virus vaccine in the last 2 months.I can take care of myself and am up and about more than half of my waking hours.I've had treatments for endometrial cancer, but my last treatment was over 4 weeks ago.I have not received any viral or gene therapy before signing up.I have severe heart issues or uncontrolled heart rhythm problems.I am not currently on any experimental treatments.I haven't had targeted therapy in the last 4 weeks.I do not have an infection needing treatment within the last 5 days.Your total bilirubin level is not more than 1.5 times the upper limit of normal.Your white blood cell count is at least 1500 per microliter.My cancer is one of the specified types of epithelial cell cancer.Your blood clotting time should not be more than 1.4 times the normal level, unless you are taking warfarin, in which case it should not be more than 3.5 times the normal level.I have had hepatitis B, C, or chronic hepatitis.Your creatinine level in your blood is less than or equal to 2.0 mg/dL, and this test was done within the last 14 days before you join the study.I have had vaginal brachytherapy before.Your hemoglobin level is between 10 and 14 grams per deciliter.I have no severe side effects from immunotherapy.
- Group 1: Arm A (VSV-hIFNbeta-NIS, TFB-PET, biopsy)
- Group 2: Arm B (ruxolitinib, VSV-hIFNbeta-NIS, SPECT/CT,TFB-PET,biopsy)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is there capacity for additional participants in this examination?
"Affirmative. The details provided by clinicaltrials.gov suggest that this medical trial is still accepting participants, having been initially posted on September 15th 2017 and most recently updated on July 14th 2022. 77 individuals from one site are required to complete the study's requirements."
What is the primary purpose of this medical experiment?
"The main outcome of this trial, observed over a 28-day span, is the incidence of adverse reactions. Other objectives include quantifying viral replication and shedding through reverse transcriptase polymerase chain reaction (using descriptive statistics and scatterplots) as well as assessing biodistribution/kinetics in vivo with single photon emission computed tomography/computed tomatography scans. Additionally, treatment related grade 3+ toxicity will be recorded using NCI CTCAE version 4 standards; simple summaries along with Kaplan-Meier survival estimates plus confidence intervals will be calculated to measure impact based on dose and other dichotomized factors like age via log"
Has this Pharmacological Study been certified by the FDA?
"As this is a Phase 1 study, the safety rating of Pharmacological Study was assigned as a low score of 1 due to limited evidence in terms of efficacy and risk mitigation."
How many participants are being monitored during this clinical research?
"That is accurate. Clinicaltrials.gov has the most up-to-date information, which reveals that this clinical trial was first posted on September 15th 2017 and last updated on July 14th 2022. Currently, 77 participants are needed from 1 medical facility to join this research study."
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