This research study is evaluating a drug called buparlisib (BKM120) as a possible treatment for locally advanced head and neck squamous cell cancer.
Name: BKM120Description: BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.Type: Drug
Name: CisplatinDescription: Cisplatin is a chemotherapy drugType: Drug
Name: Intensity-modulated radiotherapy (IMRT)Description: IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cellsType: Radiation
Description: Determine Maximum Tolerated Dose (MTD) of BKM120/cisplatin in combination with radiation therapy in patients with locally advanced squamous cell cancer of the head and neck.Measure: Determine Maximum Tolerated Dose (MTD) of BKM120/cisplatin combination with radiation therapy Time: 2 Years
Single Group Assignment
There is one SNP
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within normal range - Serum bilirubin within normal range (or ≤ 1.5 x ULN if liver metastases are present; or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome) - Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 mL/min - Serum amylase ≤ ULN - Serum lipase ≤ ULN - Fasting plasma glucose ≤ 120 mg/dL (6.7 mmol/L) - Signed informed consent - INR ≤ 2 Exclusion Criteria: - Distant metastatic disease - Less than or equal to 10 pack years of tobacco history - Received prior chemotherapy - Received prior radiation to the head and neck or adjacent anatomical site - Received prior treatment with a P13K inhibitor. --- P13K ---