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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00054795




Registration number
NCT00054795
Ethics application status
Date submitted
10/02/2003
Date registered
13/02/2003
Date last updated
8/05/2007

Titles & IDs
Public title
Study of Neurologic Progression With Motexafin Gadolinium and Radiation Therapy (SMART)
Scientific title
Randomized Phase III Trial of Xcytrin® (Motexafin Gadolinium) Injection for the Treatment of Brain Metastases in Patients With Non-Small Cell Lung Cancer Undergoing Whole Brain Radiation Therapy
Secondary ID [1] 0 0
PCYC-0211
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain Neoplasms 0 0
Carcinoma, Non-Small-Cell Lung 0 0
Metastases, Neoplasm 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Motexafin Gadolinium

Treatment: Drugs: Motexafin Gadolinium
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
- Adults (=18 years old) with radiologically proven parenchymal brain metastases from
histologically confirmed non-small cell lung cancer;

- KPS score of =70;

- Each patient must sign a study-specific Informed Consent form
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Liver metastases;

- Extracranial metastases in two or more organs;

- Known leptomeningeal metastases or subarachnoid spread of tumor;

- Prior whole brain radiation;

- Plan to use radiosurgery or radiation boost after completion of WBRT;

- Planned chemotherapy during study treatment (prior and subsequent chemotherapy is
allowed);

- Prior total resection of a single brain metastasis;

- Laboratory values as follows:

LDH > 1.3 x upper limit of normal (ULN); ANC < 1500 /mm³; Platelets < 50,000 /mm³;
Creatinine > 2.0 mg/dL; AST or ALT > 2 x ULN; Total bilirubin > 2 x ULN;

- Women who are pregnant or lactating

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
- Liverpool
Recruitment hospital [2] 0 0
- St. Leonards
Recruitment hospital [3] 0 0
- Wollongong
Recruitment hospital [4] 0 0
- Herston
Recruitment hospital [5] 0 0
- Woollongabba
Recruitment hospital [6] 0 0
- East Melbourne
Recruitment hospital [7] 0 0
- Footscray
Recruitment hospital [8] 0 0
- Geelong
Recruitment hospital [9] 0 0
- Heidelberg
Recruitment postcode(s) [1] 0 0
- Liverpool
Recruitment postcode(s) [2] 0 0
- St. Leonards
Recruitment postcode(s) [3] 0 0
- Wollongong
Recruitment postcode(s) [4] 0 0
- Herston
Recruitment postcode(s) [5] 0 0
- Woollongabba
Recruitment postcode(s) [6] 0 0
- East Melbourne
Recruitment postcode(s) [7] 0 0
- Footscray
Recruitment postcode(s) [8] 0 0
- Geelong
Recruitment postcode(s) [9] 0 0
- Heidelberg
Recruitment outside Australia
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United States of America
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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Illinois
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Indiana
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Nebraska
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New Jersey
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New Mexico
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New York
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Ohio
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Pennsylvania
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Tennessee
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Texas
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Virginia
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Wisconsin
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Austria
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Linz
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Austria
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Wien
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Belgium
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Antwerpen
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Belgium
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Bruxelles
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Belgium
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Haine-Saint-Paul
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Belgium
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Leuven
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Canada
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Alberta
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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France
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Caen
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France
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Lille
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France
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Lyon
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France
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Montbeliard
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France
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Nice
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France
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Pierre Benite
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France
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Rennes
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France
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Saint Herblain
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France
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Vandoeuvre Les Nancy
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France
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Villejuif
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Germany
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Aachen
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Germany
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Berlin
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Germany
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Essen
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Germany
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Freiberg
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Herne
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Germany
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Magdeburg
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Germany
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Munchen
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Netherlands
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Gravenhage
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Netherlands
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Heerlen
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Netherlands
State/province [55] 0 0
Rotterdam

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pharmacyclics LLC.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The primary purpose of the study is to determine if patients with brain metastases from
non-small cell lung cancer treated with Motexafin Gadolinium and whole brain radiation
therapy retain their neurologic function and ability to think for a longer time compared to
patients treated with whole brain radiation therapy alone.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00054795
Trial related presentations / publications
Mehta MP, Shapiro WR, Glantz MJ, Patchell RA, Weitzner MA, Meyers CA, Schultz CJ, Roa WH, Leibenhaut M, Ford J, Curran W, Phan S, Smith JA, Miller RA, Renschler MF. Lead-in phase to randomized trial of motexafin gadolinium and whole-brain radiation for patients with brain metastases: centralized assessment of magnetic resonance imaging, neurocognitive, and neurologic end points. J Clin Oncol. 2002 Aug 15;20(16):3445-53. doi: 10.1200/JCO.2002.07.500.
Carde P, Timmerman R, Mehta MP, Koprowski CD, Ford J, Tishler RB, Miles D, Miller RA, Renschler MF. Multicenter phase Ib/II trial of the radiation enhancer motexafin gadolinium in patients with brain metastases. J Clin Oncol. 2001 Apr 1;19(7):2074-83. doi: 10.1200/JCO.2001.19.7.2074.
Rosenthal DI, Nurenberg P, Becerra CR, Frenkel EP, Carbone DP, Lum BL, Miller R, Engel J, Young S, Miles D, Renschler MF. A phase I single-dose trial of gadolinium texaphyrin (Gd-Tex), a tumor selective radiation sensitizer detectable by magnetic resonance imaging. Clin Cancer Res. 1999 Apr;5(4):739-45.
Magda D, Lepp C, Gerasimchuk N, Lee I, Sessler JL, Lin A, Biaglow JE, Miller RA. Redox cycling by motexafin gadolinium enhances cellular response to ionizing radiation by forming reactive oxygen species. Int J Radiat Oncol Biol Phys. 2001 Nov 15;51(4):1025-36. doi: 10.1016/s0360-3016(01)01810-7.
Miller RA, Woodburn K, Fan Q, Renschler MF, Sessler JL, Koutcher JA. In vivo animal studies with gadolinium (III) texaphyrin as a radiation enhancer. Int J Radiat Oncol Biol Phys. 1999 Nov 1;45(4):981-9. doi: 10.1016/s0360-3016(99)00274-6.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
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Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00054795