VSV-hIFNbeta-NIS in Treating Patients With Stage IV or Recurrent Endometrial Cancer

Overview

About this study

This phase I trial studies the side effects and best dose of vesicular stomatitis virus-human interferon beta-sodium iodide symporter (VSV-hIFNbeta-NIS) in treating patients with stage IV endometrial cancer or endometrial cancer that has come back. The study virus, VSV-hIFNbeta-NIS, has been changed so that it has restricted ability to spread to tumor cells and not to healthy cells. It also contains a gene for a protein, NIS, which helps the body concentrate iodine making it possible to track where the virus goes. VSV-hIFNbeta-NIS may be able to kill tumor cells without damaging normal cells.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age ≥ 18 years old.
  • 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 RECIST (version 1.1).
  • Group A only: Largest tumor diameter ≤ 5cm.
    • NOTE: Group B patients have no maximum tumor size.
  • The following laboratory values obtained ≤14 days prior to registration:
    • Absolute Neutrophil Count (ANC) ≥1500/μL;
    • Platelet Count (PLT) ≥00,000/μL;
    • Hemoglobin ≥10 g/dL;
    • Creatinine ≤2.0 mg/dL;
    • AST and ALT ≤2 x upper limit of normal (ULN);
      • NOTE: If baseline liver disease, Child Pugh score not exceeding Class A.
    • Total bilirubin ≤.5 x ULN;
    • INR/PT, aPTT ≤1.4 x ULN unless on therapeutic warfarin then INR/PT≤ 5.
  • Ability to provide written informed consent.
  • Willingness to return to Mayo Clinic in Rochester, Minnesota for follow-up.
  • Life expectancy ≥ 2 weeks.
  • 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, 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 CNS disorder or seizure disorder or known CNS disease or neurologic symptomatology.
  • 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-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 CTCAE >Grade 1 at the time of registration.
  • Receipt of a live virus vaccine ≤ 2 months prior to registration.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Jamie Bakkum-Gamez, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20317238

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