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Lung Cancer Clinical Trial

Epigenetic Therapy for Patients with Surgically Resected Early Stage Lung Cancer

Traditionally, patients with early stage lung cancer have been monitored with CT screenings to see if the cancer returns, there have been no additional treatment options for surgery. Now, at Johns Hopkins, there is a new therapy that is being investigated for patients after surgery. This new treatment utilizes epigenetic therapy in the treatment of early stage lung cancer.

The experimental use of epigenetic therapy after surgery is being compared to the current standard of care which is supportive care after surgery for patients diagnosed with Stage 1 Non-Small Cell Lung Cancer (NSCLC).

What is Epigenetic Therapy and How is it Different?

Epigenetic therapy represents a novel concept in treating cancer. It has not been FDA-approved for the use in lung cancer. The doses of the drugs given are lower than the maximally tolerated doses of these drugs, which may limit the toxicity.

The goal of this type of therapy is not to kill the cancer cells directly. Instead, the objective is to allow the cells to live to absorb the drugs. The drugs then change the cancer cells from the inside out, making them a more normal cell. Since the Epigenetic Therapy is given in a low does, it has fewer side effects than standard chemotherapy.

Who Can Join?

Eligible participants may include those with:

  • Patients that have received complete resection of pathologically proven NSCLC (stage 1A or 1B).
  • Must be between 4-8 weeks out from surgery.
  • Must be older than 18 years of age.
  • Must not have received any chemotherapy or radiation therapy for your lung cancer.
  • Must have acceptable lab values and assessed to be in a good state of health.

What is Involved?

  • Eligble patients will be randomized to epigenetic treatment consisting of two drugs; 5-Azacitidine & Entinostat or standard of care
  • All patients will need to spit into a cup, have blood samples drawn, and receive physical examinations as well as radiological imaging.
  • Patients that are randomized to epigenetic treatment will receive subcutaneous injections in the outpatient setting on days 1-5 and 8-10, and an oral agent on days 3&10 of each 28-day cycle. Up to 6 cycles of treatment will be given.
  • Patients randomized to standard of care will be followed with CT screenings and collections of research labs every 3 months for the first 2 years and then every 6 months after that.

For More Information

If you think this trial may be right for you, contact us. We will help determine if you may be eligible for the trial and answer any questions.

Joanne Riemer, RN
443-287-4114 - jriemer2@jhmi.edu

Malcolm Brock, M.D.
410-955-8506 - mabrock@jhmi.edu

Charles Rudin, M.D.
410-502-0678 - rudin@jhmi.edu

Beverly Lee/Kristen Rodgers
410-955-9047

This study is funded by Stand Up 2 Cancer

 

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