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Melanoma - Healing Genes
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Melanoma

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Modified Virus VSV-IFNbetaTYRP1 in Treating Patients With Stage III-IV Melanoma

Phase I Trial to Evaluate the Safety and Efficacy of Intratumoral and Intravenous Injection of Vesicular Stomatitis Virus Expressing Human Interferon Beta, and Tyrosinase Related Protein 1 (VSV-IFNb-TYRP1) in Patients With Metastatic Ocular Melanoma and Previously Treated Patients With Unresectable Stage III/IV Cutaneous Melanoma


Phase 1

DESCRIPTION:

Doctors at the Mayo Clinics in Florida and Minnesota seek participants in a clinical investigation of a new treatment for Stage III to IV Melanoma. The treatment injects a virus that has been gene-edited to include the following genes:

  • A gene to protect healthy cells from becoming infected with the virus
  • A gene that will be expressed by melanoma tumor cells to trigger an immune response to kill the tumor cells

Researchers hope these genes, transferred by the virus, will lead patients’ immune systems to slow or reverse the growth of their tumors. Half the enrolled patients will receive one dose and half will receive several doses, repeating every 21 days for several cycles.


PATIENT MUST:

  • Be 18 years of age or older
  • Have confirmed diagnosis of unresectable stage III or metastatic (stage IV) melanoma, including metastatic ocular melanoma, meeting criteria for certain diameters
  • Not be pregnant or breastfeeding
  • Meet several screening requirements regarding the status of their cancer and overall health, past treatments, and their current medications

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate, including 1 to 2 weeks of repeated lab screenings
  2. Initial injection for both groups A and B will be intratumorally over a few hours on Day 1. At this point, the group A patients are complete and will visit for follow up at 42 days from treatment.
  3. Group B patients wait 28 days, then receive the same treatment again, repeating it every 21 days for several cycles.
  4. Patients in Group B are followed up at 28 days, every 3 months until progressive disease, and then every 6 months for a maximum of 5 years after study registration.

LOCATIONS AND CONTACTS:

The study site is at the Mayo Clinic in Jacksonville, FL (Map) and the Mayo Clinic in Rochester, MN (Map).

Contacts: Clinical Trials Referral Office | 855-776-0015

 

SPONSOR INFORMATION:

Mayo Clinic

The National Cancer Institute (NCI)

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03865212

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