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WITHDRAWNPHASE2

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

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

NCT02014545•Wake Forest University Health Sciences

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, United States

Key Dates

Start Date

January 1, 2016

Primary Completion Date

November 29, 2017

Completion Date

November 29, 2017

Last Updated

July 5, 2018

Conditions

Brain MetastasesNon-small Cell Lung Cancer

Interventions

Lucanthone

DRUG

Placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 5, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

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Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

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