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Lung Cancer (NSCLC) - Healing Genes
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Lung Cancer (NSCLC)

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Oncolytic Adenovirus-Mediated Gene Therapy for Lung Cancer (NSCLC)

Phase 1 Trial of Oncolytic Adenovirus-Mediated Cytotoxic Gene Therapy in Combination With Stereotactic Body Radiation Therapy (SBRT) in Clinical Stage 1/11A (T1A-T2B) Non-Small Cell Lung Cancer


Phase 1

DESCRIPTION:

Doctors at the Henry Ford Health System are investigating a treatment for medically inoperable non-small cell lung cancer. The therapy involves a single injection of a genetically engineered adenovirus to target and infect cancer cells, transferring to them a cancer suicide gene called HSV-tK to their tumor. In combination with valganciclovir (vGCV), a prodrug therapy, 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 and chemotherapy.

Follow up will be required twice a week for the first 2 weeks and then at scheduled follow-up visits through 60 months.


PATIENT MUST:

  • Be 18 years of age or older
  • Have a diagnosis of NSCLC meeting clinical criteria for staging and size
  • Must agree to contraception for at least 2 months after the gene therapy
  • Not have received chemotherapy for the cancer being treated

THE STUDY INVOLVES:

  1. Prescreening tests to confirm eligibility of the patient to participate.
  2. Depending on the location of the target lesion, the therapy will be injected either transbronchially (central tumors) or through the skin with help of imaging to guide it.
  3. Two days later, subjects will be administered (orally) a 10 day course of chemotherapy and valganciclovir (vGCV) prodrug therapy along with Stereotactic Body Radiation Therapy.
  4. Prior to and following the adenovirus injection, subjects will be given a will undergo PET imaging, after receiving a radiotracer, to quantify the desired suicide gene expression.
  5. Toxicity assessments will occur twice a week for the first 2 weeks and then at scheduled follow-up visits through 60 months.

LOCATIONS AND CONTACTS:

The study site is at Henry Ford Health System in Detroit, MI. Map.

Contacts:

Benjamin Movsas, MD  |  [email protected]
Janice Freytag, BS  |  313-874-8326  |  [email protected]

 

SPONSOR INFORMATION:

Benjamin Movsas, M.D.

 

Or go online:

https://clinicaltrials.gov/ct2/show/NCT03029871

 

 

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