A Phase I/II Study of MS 275 in Combination with 5-azacytidine in Patients with Recurrent Advanced Non-Small Cell Lung Cancer
To help us best learn how to use new drugs which may be effective against lung cancer. Study combines DNA methyltransferase inhibitor 5-Azacytidine with oral histone deacetylase inhibitor MS-275 for treatment of recurrent advanced Non-Small Cell Lung Cancer. To assess safety, side effects, dose, response rate, and effect on patient's progression-free and overall survival.
Confirmed measurable (at least one lesion 10-20mm or more) metastatic or non-removeable Non-Small Cell Lung Cancer. Has failed at least one prior chemotherapy regimen. No allergy to mannitol,or compounds similar to MS-275 or 5- AZA. May not have greater than 30% of liver parenchyma replaced by metastases. Good organ and blood function. Ability to give informed consent.
Outpatient and planned for at least 2 cycles. (If tumor shrinks or disappears treatment may continue as long as drugs are helping.)5-AZA injections are given on 9 days of each 28 day cycle. MS-275 pills are given by mouth on 2 of those days. Blood is checked. Scans of tumor done every 8 weeks. For those participants who volunteer, an additional fine needle biopsy is done 3 times during first cycle.
03/07/2014 04:02 AM