Phase 1 Study Evaluating Safety of LEAD Radiotherapy Plus Chemoradiation in Patients With Bulky Stage III Non-Small Cell Lung Cancer

• Status: Terminated
• Trial end date: 0000-00-00
• Target enrollment: 1
• Participant gender: Both

Summary

The investigators aim to evaluate the safety of delivering a one-time single fraction of Lattice Extreme Ablative Dose (LEAD) radiotherapy followed one day later by standard-dose, conventionally fractionated concurrent chemotherapy and radiation delivered over 6 weeks in patients with bulky stage III non-small cell lung cancer in the setting of a single-arm phase I clinical trial. The investigators hypothesize that the addition of a one-time single fraction of LEAD radiation is safe and feasible, and will not result in additional toxicity above that expected with standard-dose concurrent chemotherapy and radiation alone.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Last Updated: 2016-12-14

Criteria

Inclusion Criteria:

• Patients must have histologically or cytologically documented stage III non-small cell lung cancer including squamous cell, adenocarcinoma, large cell carcinoma and poorly differentiated non-small cell lung cancer.

• Patients must have a minimum of 4 cm of measureable disease in any one continuous dimension as seen on diagnostic CT scan.

• Pulmonary function tests with FEV1 >= 1.45 liters/second.

• Patients must be 21 years of age or older. There is no maximum age restriction.

• Patients must have a Zubrod performance status of 0 or 1.

• Patients must have normal organ and marrow function as defined below:

• leukocyte > 3,000/:I

• absolute neutrophil count >1,500/:1

• platelets >100,000/:1

• bilirubin within normal institutional limits

• AST(SGOT)/ALT(SGPT) 2.5 X institutional upper limit of normal

• Creatinine within normal institutional limits OR creatinine clearance > 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

• Patients must have weight loss ≤ 10% over the past three months.

• Women of child-bearing potential and men will be asked to use adequate contraception.

• Patients must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

• Patients may not have had prior thoracic radiation at any time, or prior chemotherapy for the study cancer at any time.

• Patients may not be receiving any other investigational agents for the study cancer.

• Patients may not have evidence of brain metastases on baseline CT scan or MRI.

• Patients may not have measurable gross disease in the thorax <4 cm in any one continuous dimension.

• Patients may not have a cytologically positive pleural effusion.

• Patients may not have a prior invasive malignancy (unless disease-free for at least 3 years).

• Patients may not have had surgical resection of the present cancer.

• Women who are pregnant or breastfeeding will be excluded.

• Patients must not have any co-morbidity with life expectancy ≤ 6 months, or any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

• Patients must not have severe lung disease defined by a history of severe COPD requiring 3 or more hospitalizations over the past year, or history of interstitial pneumonitis.

• Patients must not have any concurrent active malignancy.

• Patients must not have evidence of metastatic disease.