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

NCT ID: NCT02014545

Last Updated: 2018-07-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-11-29

Brief 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.

Detailed 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.

Conditions

Brain Metastases; Non-small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

WBRT + Lucanthone

Treatment will consist of WBRT given in a dose of 30 Gy in ten fractions with lucanthone given as an adjunct. Lucanthone will be administered as 25 mg and 100 mg tablets to be swallowed. Dosage will be one of the following: 250 mg bid, 250 tid, or 375 mg tid.

Group Type: ACTIVE_COMPARATOR

Lucanthone

Intervention Type: DRUG

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.

WBRT + Placebo

Patients will receive prophylactic cranial irradiation at 3 Gy per fraction, 5 days per week, for 2 weeks to a total dose of 30 Gy.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Only standard treatment of whole brain radiation therapy is done.

Interventions

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.

Intervention Type: DRUG

Placebo

Only standard treatment of whole brain radiation therapy is done.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectrum Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stefan C. Grant, MD, JD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00037529

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00037529

Identifier Type: -

Identifier Source: org_study_id