Clinical Trial: Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cancer of Head and Neck

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase Ib Study of BKM120 With Weekly Cisplatin and Radiotherapy in High Risk Locally Advanced Squamous Cell Cancer of the Head and Neck

Brief Summary: This research study is evaluating a drug called buparlisib (BKM120) as a possible treatment for locally advanced head and neck squamous cell cancer.

Detailed Summary:

  • This phase Ib study is combining standard chemoradiotherapy with weekly cisplatin and BKM120 to assess tolerability of this combination in high risk patients with locally advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN). The investigators will also obtain preliminary information about the efficacy of this treatment.
  • The participant will receive the study drug buparlisib once daily, by mouth, for 45 days. The participant will be given a study drug-dosing diary for each cycle. It will include special instructions for taking the study drug at home.
  • The investigators are looking for the highest dose of the study drug that can be administered safely without severe or unmanageable side effects, not everyone who participates in this research study will receive the same dose of the study drug. The dose given will depend on the number of participants who have been enrolled in the study before and how well they have tolerated their doses.
  • All participants will receive weekly cisplatin injection. Cisplatin will be given intra-venously (IV) on days: (1, 8, 15, 22, 29, 36 and 43) at DFCI.
  • All participants will receive daily radiotherapy with intensity-modulated radiotherapy (IMRT) for 7 weeks, delivered at DFCI. IMRT is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor.
  • The investigators would like to keep track of the participant's medical condition. Follow-up will continue every 4 to 12 weeks after the end of treatment for the first year and at the investigator's discretion ther
    Sponsor: Dana-Farber Cancer Institute

    Current Primary Outcome: Determine Maximum Tolerated Dose (MTD) of BKM120/cisplatin combination with radiation therapy [ Time Frame: 2 Years ]

    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.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Overall Response Rate [ Time Frame: 2 Years ]
    • Time to Progression [ Time Frame: 2 Years ]
    • Survival [ Time Frame: 2 years ]
    • Mood alteration from BKM120 [ Time Frame: 2 Years ]
    • Activity of BKM120 as single agent in sequential biopsies [ Time Frame: 2 Years ]


    Original Secondary Outcome: Same as current

    Information By: Dana-Farber Cancer Institute

    Dates:
    Date Received: April 1, 2014
    Date Started: October 2014
    Date Completion: March 2020
    Last Updated: December 29, 2016
    Last Verified: December 2016