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Metastatic Non-Small Cell Lung Carcinoma and Uveal Melanoma - Healing Genes
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Metastatic Non-Small Cell Lung Carcinoma and Uveal Melanoma

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Trial of Radiation and Gene Therapy Before Nivolumab for Metastatic Non-Small Cell Lung Carcinoma and Uveal Melanoma (ENSIGN)

ENSIGN: Phase II Window of Opportunity Trial of Stereotactic Body Radiation Therapy and In Situ Gene Therapy Followed by Nivolumab in Metastatic Squamous or Non-Squamous Non-Small Cell Lung Carcinoma and Metastatic Uveal Melanoma


Phase 2

DESCRIPTION:

Houston Methodist Hospital is conducting a trial of an experimental treatment formetastatic squamous or non-squamous non-small cell lung carcinoma (NSCLC) and metastatic uveal melanoma. The therapy uses a virus to deliver a cancer suicide gene called HSV-tK to their tumor. In combination with valocyclovir medicine, this gene may cause the cancer to self-detonate by incorporating a molecule that stops their replication. This experimental treatment will be delivered along with standard radiation before nivolumab treatment follows.

The investigational treatment will be delivered by injection into the tumor followed by valacyclovir oral medication. Radiation will continue for two weeks, with FDA-approved nivolumab to follow every four weeks for up to 12 months. The outcomes being measured will happen between the experimental treatment and the nivolumab treatment, but follow up continues until nivolumab treatment ends.


PATIENT MUST:

  • Be 18 years of age or older
  • Have a diagnosis of metastatic NSCLC or uveal melanoma cancer meeting study clinical criteria
  • Have a life expectancy of 6 months or more
  • Be willing to use birth control, if sexually active

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. At day 1 of treatment, the viral gene therapy will be injected into the tumor, and Valocyclovir administered for 14 days beginning 24 hours after the injection.
  3. Radiation therapy will be administered for 2 weeks.
  4. After step (3), tests and assessments will take place before FDA-approved nivolumab treatment every four weeks for up to 12 months.
  5. Follow up continues for up to 30 days after the last dose of nivolumab.

LOCATIONS AND CONTACTS:

The study sites are at the Houston Methodist Hospital in Houston, TX. Map.
 
Contacts:
Houston Methodist Cancer Center  |  713-441-0629  |  [email protected]
 
SPONSOR INFORMATION:
Eric Bernicker, MD
 
Or go online:
https://clinicaltrials.gov/ct2/show/NCT02831933

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