Virus therapy targets Hard-to-Treat endometrial cancer
NCT ID NCT03120624
First seen Jun 27, 2026 · Last updated Jul 22, 2026 · Updated 2 times
Summary
This early-stage trial tests a specially modified virus (VSV-hIFNbeta-NIS) given through an IV to people with advanced or recurrent endometrial cancer. The virus is designed to attack cancer cells while leaving healthy cells alone, and it includes a tracer to see where it goes in the body. Some participants also receive a second drug (ruxolitinib) to boost the virus's effect. The main goal is to find the safest dose and check for side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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34 people
The number who actually took part.
- Started
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Sep 2017
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial carcinoma * NOTE: histologic confirmation of the original primary tumor is required; patients with the following histologic epithelial cell types are eligible: Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, carcinosarcoma, adenocarcinoma not otherwise specified (NOS) * NOTE: measurable disease is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) * Group A only: Largest tumor diameter =\< 5 cm * NOTE: Group B patients have no maximum tumor size * Absolute neutrophil count (ANC) \>= 1500/uL (obtained =\< 14 days prior to registration) * Platelet count (PLT) \>= 100,000/uL (obtained =\< 14 days prior to registration) * Hemoglobin \>= 10 g/dL (obtained =\< 14 days prior to registration) * Creatinine =\< 2.0 mg/dL (obtained =\< 14 days prior to registration) * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2 x upper limit of normal (ULN) (obtained =\< 14 days prior to registration) * NOTE: if baseline liver disease, Child Pugh score not exceeding class A * Total bilirubin =\< 1.5 x ULN (obtained =\< 14 days prior to registration) * International normalized ratio (INR)/prothrombin time (PT), activated partial thromboplastin time (aPTT) =\< 1.4 x ULN (obtained =\< 14 days prior to registration) unless on therapeutic warfarin then INR/PT =\< 3.5 * Ability to provide written informed consent * Willingness to return to Mayo Clinic in Rochester, Minnesota for follow-up * Life expectancy \>= 12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 * Willingness to provide mandatory biological specimens for research purposes * Prior therapy: * Any number of prior chemotherapy regimens and/or targeted therapies and/or prior external beam radiation therapy and/or prior hormonal therapy for endometrial cancer are allowed provided the last treatment was \>= 4 weeks prior to registration * Vaginal brachytherapy may have been administered at any time prior to registration Exclusion Criteria: * Availability of and patient acceptance of curative therapy * Active infection requiring treatment, including any active viral infection, =\< 5 days prior to registration * Active or latent tuberculosis or hepatitis * Known untreated or symptomatic brain metastases * Any of the following prior therapies: * Chemotherapy \< 4 weeks prior to registration * Targeted biologic therapy \< 4 weeks prior to registration * Immunotherapy \< 4 weeks prior to registration * Any viral or gene therapy prior to registration * External beam radiotherapy \< 4 weeks prior to registration * NOTE: Vaginal brachytherapy may be performed at any time prior to registration * New York Heart Association classification III or IV, known symptomatic coronary artery disease, or symptoms of coronary artery disease on systems review, or uncontrolled current cardiac arrhythmias (atrial fibrillation or supraventricular tachycardia \[SVT\]) * Active central nervous system (CNS) disorder or seizure disorder or known CNS disease or neurologic symptomatology * Human immunodeficiency virus (HIV) positive test result or other immunodeficiency or immunosuppression * History of hepatitis B or C or chronic hepatitis * Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (used for a non-Food and Drug Administration \[FDA\] approved indication and in the context of a research investigation) * Treatment with oral/systemic corticosteroids, with the exception of topical or inhaled steroids * Exposure to household contacts =\< 15 months old or household contact with known immunodeficiency * Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown: * Pregnant persons or persons of reproductive ability who are unwilling to use effective contraception * Nursing persons * Any other pathology or condition that the principal investigator deems to negatively impact treatment safety * Any immunotherapy-related adverse events Common Terminology Criteria for Adverse Events (CTCAE) \> grade 1 at the time of registration * Receipt of a live virus vaccine =\< 2 months prior to registration
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Hormone blocker plus targeted drug shows promise against tough uterine cancer
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- New drug duo shows promise for Tough-to-Treat endometrial cancer
- Heated chemo during surgery may fight ovarian cancer return