Evaluation of Lucanthone to Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

Phase II Trial Evaluating the Addition of Lucanthone to Whole Brain Radiation Therapy in Patients With Brain Metastases From Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02014545
• Other study ID #: IRB00037529
• Secondary ID: IRB00037529
• Status: Withdrawn
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: November 29, 2017

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double blind placebo controlled study to evaluate safety and efficacy of lucanthone administered as an adjunct to patients receiving whole brain radiation therapy (WBRT) as primary treatment for brain metastases secondary to non-small cell lung cancer.

Description:

Eligible patients for this trial will be randomized to lucanthone or placebo in a ratio of 1:1. The treatment will consist of WBRT given in a dose of 30 Gy in ten fractions. Lucanthone/placebo will be given as an adjunct to the WBRT on days that WBRT is administered. Tumor assessments will be done with a brain MRI. Radiological assessments on the tumor will be made periodically throughout the study and will be discontinued at the time of tumor progression. Safety will be evaluated for one year during the study period and survival data will be collected thereafter.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 29, 2017
• Est. primary completion date: November 29, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• The patient has given informed consent.

• The patient is willing and able to abide by the protocol.

• The patient is between age 18 and 70 (between 19 and 70 in Alabama).

• The patient has histologically proven NSCLC with radiologically documented brain metastases.

• Newly diagnosed or stable systemic disease, on or off systemic therapy.

• If receiving systemic therapy for NSCLC, at least two weeks since patient received systemic therapy.

• Able to withhold systemic therapy for duration of WBRT therapy.

• If the patient is of childbearing potential, he/she is using an acceptable/effective method of contraception.

• The patient's Karnofsky Score is greater than or equal to 70%.

Exclusion Criteria:

• Patient has a diagnosis of recurrent brain metastases.

• The patient has an absolute neutrophil count less than or equal to 1.5 X 10 9/L.

• The patient has a screening platelet count less than 100,000/uL.

• The patient has a screening bilirubin greater than 1.6 mg/dL.

• The patient has a screening creatinine greater than 2.25 mg/dL in men and 1.8 mg/dL in women.

• The patient has a screening ALT/AST greater than 2.5 times the upper limit of the laboratory reference range.

• The patient has an unstable medical condition or significant comorbid pathophysiology (e.g. active infection, poorly controlled diabetes, unstable angina, severe heart failure) that would interfere with his/her participation in the study.

• The patient is enrolled, or plans to enroll, in a concurrent treatment protocol with another investigational product.

• The patient has received prior chemotherapy or radiation therapy within two weeks of beginning WBRT on protocol.

• The patient is allergic to gadolinium contrast.

• More than 21 days has or will elapse between the brain MRI documenting the brain metastases and the initiation of WBRT.

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Non-small Cell Lung Cancer

Intervention

Drug:
• Lucanthone
The dose of lucanthone to be administered will be calculated based on the patient's body weight. The dose to be given will be 250 bid, 250 tid or 375 tid dependent upon study progression.

Other:
• Placebo
Only standard treatment of whole brain radiation therapy is done.

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Spectrum Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the efficacy of lucanthone when given during WBRT	Progression free survival at 6 months and one year, overall response rate at months 1, 4, 7, 10, and 13 months and overall survival at 13 months will be evaluated. MRI brain scans will be performed baseline and months 1, 4, 7, 10, and 13. Objective assessments of overall response will be based on tumor assessments from MRI scans interpreted using the Revised Assessment in Neuro-Oncology (RANO) criteria.	2 weeks to 13 months
Secondary	Evaluate the safety and toxicity of lucanthone when used in combination with standard doses of WBRT in the primary treatment of brain metastases secondary to non-small cell lung cancer	Safety will be monitored throughout the study by physical exams, review of adverse events, and laboratory studies.	2 weeks to 13 months