None listed
Conditions
Brief summary
The study will find the right amount of dose of a new oral drug called LBH589 in combination with radiation or chemoradiation for locally advanced lung cancer.
Interventions
Intervention group 1:
LBH589, an oral histone deacetylase inhibitor, will be combined with radiation for treatment of stage III non small cell lung cancer (NSCLC) in 3 increasing dose levels- 20 mg, 30 mg and 45 mg. The drug is administered orally. The radiation will be delivered to a total dose of 40 Gy in 2 Gy per fraction. 3 patients will start treatment with 20 mg LBH589 and radiation and observed for dose limiting toxicities. In case of no or minimal toxicities the next 3 patients will be t
Intervention group 1: LBH589, an oral histone deacetylase inhibitor, will be combined with radiation for treatment of stage III non small cell lung cancer (NSCLC) in 3 increasing dose levels- 20 mg, 30 mg and 45 mg. The drug is administered orally. The radiation will be delivered to a total dose of 40 Gy in 2 Gy per fraction. 3 patients will start treatment with 20 mg LBH589 and radiation and observed for dose limiting toxicities. In case of no or minimal toxicities the next 3 patients will be treated at second dose level i.e. 30 mg. The next and final dose level will be 45 mg. A patient will be treated at only one particular dose level. The treatment will last for the duration of radiation, i.e. 4 weeks. Intervention group 2: Patients with stage III NSCLC will be treated with chemoradiation plus LBH589 in three increasing dose levels 20 mg, 30 mg and 45 mg. The total treatment duration will be 6 weeks. Radiation will be given at the dose of 60 Gy- 2 Gy per fraction. The chemotherapy will be intravenous cisplatin (50mg/m2 Days 1, 8 every 3 weeks) plus oral vinorelbine (50mg/m2 Days 1, 8 every 3 weeks) for 2 cycles. The first 3 patients will start treatment at 20 mg LBH589 with chemoradiation and observed for dose limiting toxicities. In case of no or minimal toxicities, the next three patients will be treated at 30 mg dose level. The final dose level will be 45 mg. The dose of chemotherapy and raditaion will remain constant throughout. A patient will be treated at only one dose level of LBH589 whether they experience any toxicity or not.
Sponsors
Royal Adelaide Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Histological or cytological diagnosis of locally advanced (stage III) NSCLC Adequate organ function Performance score < 2 Adequate lung functions with forced expiratory volume (FEV1) > 1 L
Exclusion criteria
Concurrent treatment with other histone deacetylase inhibitors such as sodium valproate Concurrent treatment with anti-arrythmics with a tendency to prolong QTc interval. Patients on other investigational drugs within last 30 days Pregnant or lactating females Patients who have any severe and/or uncontrolled medical conditions Malabsorption syndrome
Outcome results
None listed