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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02014545
Recruitment Status : Withdrawn (Pending resolution of study drug issues)
First Posted : December 18, 2013
Last Update Posted : July 5, 2018
Sponsor:
Collaborator:
Spectrum Pharmaceuticals, Inc
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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.

Condition or disease Intervention/treatment Phase
Brain Metastases Non-small Cell Lung Cancer Drug: Lucanthone Other: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2016
Actual Primary Completion Date : November 29, 2017
Actual Study Completion Date : November 29, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Active Comparator: 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.
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.

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




Primary Outcome Measures :
  1. Determine the efficacy of lucanthone when given during WBRT [ Time Frame: 2 weeks to 13 months ]
    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.


Secondary Outcome Measures :
  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 [ Time Frame: 2 weeks to 13 months ]
    Safety will be monitored throughout the study by physical exams, review of adverse events, and laboratory studies.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02014545


Locations
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United States, North Carolina
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Spectrum Pharmaceuticals, Inc
Investigators
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Principal Investigator: Stefan C. Grant, MD, JD Wake Forest University Health Sciences

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02014545    
Other Study ID Numbers: IRB00037529
IRB00037529 ( Other Identifier: CCCWFU )
First Posted: December 18, 2013    Key Record Dates
Last Update Posted: July 5, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wake Forest University Health Sciences:
brain metastases
non-small cell lung cancer
whole brain radiation therapy
lucanthone
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lucanthone
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents