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

NCT02014545 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: IRB00037529
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Metastases; Non-small Cell Lung Cancer

Keywords

brain metastases; non-small cell lung cancer; whole brain radiation therapy; lucanthone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

  2 weeks to 13 months

Study Arms (2)

WBRT + Lucanthone

ACTIVE COMPARATOR

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.

Drug: Lucanthone

WBRT + Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Lucanthone 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 + Lucanthone

Placebo OTHER

Only standard treatment of whole brain radiation therapy is done.

WBRT + Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Spectrum Pharmaceuticals, Inc: collaborator

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Lucanthone

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Thioxanthenes; Sulfur Compounds; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Xanthones

Study Officials

• Stefan C. Grant, MD, JD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2013
• First Posted: December 18, 2013
• Study Start: January 1, 2016
• Primary Completion: November 29, 2017
• Study Completion: November 29, 2017
• Last Updated: July 5, 2018

Record last verified: 2018-07

Locations

US (1)