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Radiation Therapy With or Without RSR13 in Treating Patients With Brain Metastases

Sponsor
Spectrum Pharmaceuticals, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT00005887
Collaborator
(none)
73
Locations
35
Actual Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as RSR13 may make tumor cells more sensitive to radiation therapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the brain with or without RSR13 in treating patients who have brain metastases.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

OBJECTIVES:

  • Compare the median survival time in patients with brain metastases after receiving treatment with whole brain radiotherapy with or without RSR13.

  • Compare the response rate to these treatment regimens in these patients.

  • Compare the time to progression after receiving these treatment regimens in these patients.

  • Compare quality of life in these patients receiving these treatment regimens.

  • Compare cause of death (neurologic vs nonneurologic death) in these patients after receiving these treatment regimens.

  • Determine the safety of RSR13 in these patients.

  • Assess the pharmacokinetics of RSR13 in these patients.

OUTLINE: This is a randomized, open label, comparative, multicenter study. Patients are stratified according to the Radiation Therapy Oncology Group RPA Class (I vs II). Patients are further stratified within the RPA class II stratum according to site of primary cancer (non-small cell lung cancer vs breast vs other). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive whole brain radiotherapy 5 days a week for two weeks in conjunction with supplemental oxygen breathing.

  • Arm II: Patients receive RSR13 IV over 30 minutes followed by whole brain radiotherapy and supplemental oxygen breathing as in arm I.

Quality of life is assessed at the first and last day of radiotherapy, at 1 month, 3 months, and then every 3 months until disease progression.

Patients are followed at 1 month, 3 months, every 3 months until disease progression, and then for survival.

PROJECTED ACCRUAL: A maximum of 408 (204 per treatment arm) patients will be accrued for this study.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III, Randomized, Open-Label, Comparative Study of Standard Whole Brain Radiation Therapy With or Without RSR13 in Patients With Brain Metastases
Actual Study Start Date :
Feb 1, 2000
Actual Primary Completion Date :
Jan 1, 2003
Actual Study Completion Date :
Jan 1, 2003

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:

    • Radiographically, histologically, or cytologically confirmed brain metastases with histologically or cytologically confirmed primary malignancy except the following:

    • Small cell lung cancer, germ cell tumors, and lymphomas

    • No leptomeningeal metastases

    PATIENT CHARACTERISTICS:
    Age:
    • 18 and over
    Performance status:
    • Karnofsky 70-100%
    Life expectancy:
    • Not specified
    Hematopoietic:

    • Hemoglobin at least 10 g/dL

    • WBC at least 2,000/mm3

    • Platelet count at least 75,000/mm3

    Hepatic:

    • Bilirubin no greater than 2.0 mg/dL

    • ALT and AST no greater than 3 times upper limit of normal

    Renal:
    • Creatinine no greater than 2.0 mg/dL
    Pulmonary:

    • Forced vital capacity and forced expiratory volume at least 50% of normal in patients with significant intrathoracic tumor involvement, chronic obstructive pulmonary disease, interstitial lung disease, or pulmonary embolism

    • Resting and exercise oxygen saturation at least 90% on room air

    Other:

    • No other concurrent active malignancy from a second histologic site

    • Not pregnant or nursing

    • Negative pregnancy test

    • Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:

    • No prior biologic therapy or immunotherapy for brain metastases

    • At least 28 days since prior investigational biologic therapy

    Chemotherapy:

    • No prior chemotherapy for brain metastases

    • No chemotherapy for brain metastases for at least one month following radiation therapy

    • At least 7 days since prior chemotherapy for primary tumor or extracranial metastases

    • No planned chemotherapy during radiation therapy

    Endocrine therapy:

    • No prior hormonal therapy for brain metastases

    • Prior or concurrent corticosteroid therapy allowed

    Radiotherapy:

    • No prior whole brain radiotherapy for brain metastases

    • No prior stereotactic radiosurgery for brain metastases

    Surgery:
    • Prior surgery allowed for brain metastases if at least one measurable lesion remains
    Other:

    • At least 28 days since prior investigational drug or device

    • No prior RSR13

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. Joseph's Hospital and Medical Center Phoenix Arizona United States 85001-2071
    2 Arizona Cancer Center Tucson Arizona United States 85724
    3 Alta Bates Comprehensive Cancer Center Berkeley California United States 94704
    4 California Cancer Care, Inc. Greenbrae California United States 94904
    5 Scripps Green Hospital & Scripps Clinic La Jolla California United States 92037
    6 Tower Hematology Oncology Medical Group Los Angeles California United States 90048
    7 University of Colorado Cancer Center Denver Colorado United States 80010
    8 Comprehensive Cancer Care Specialists of Boca Raton Boca Raton Florida United States 33428
    9 Citrus Memorial Hospital Inverness Florida United States 34452
    10 Decatur Memorial Hospital Cancer Care Institute Decatur Illinois United States 62526
    11 Ochsner Clinic New Orleans Louisiana United States 70121
    12 Harbor Hospital Center Baltimore Maryland United States 21225
    13 St. Agnes Healthcare Baltimore Maryland United States 21229
    14 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231-2410
    15 Lahey Clinic - Burlington Burlington Massachusetts United States 01805
    16 University of Massachusetts Memorial Medical Center Worcester Massachusetts United States 01655
    17 Cooper Hospital/University Medical Center Camden New Jersey United States 08103
    18 Monmouth Medical Center Long Branch New Jersey United States 07740-6395
    19 East Coast Radiation Oncology Toms River New Jersey United States 08755
    20 Millard Fillmore Hospital Buffalo New York United States 14209
    21 State University of New York - Upstate Medical University Syracuse New York United States 13210
    22 Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina United States 27157-1082
    23 Bismarck Cancer Center Bismarck North Dakota United States 58501-4445
    24 Akron General Medical Center Akron Ohio United States 44302
    25 Akron City Hospital Akron Ohio United States 44309
    26 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    27 Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107-5541
    28 Memphis Regional Brain Tumor Center Memphis Tennessee United States 38104
    29 Boston Baskin Cancer Group, University Tennessee Oncology/Hematology Group Memphis Tennessee United States 38119
    30 U.S. Oncology Research Inc. Dallas Texas United States 75246
    31 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030-4009
    32 University of Texas Health Science Center at San Antonio San Antonio Texas United States 78284-7811
    33 Center for Radiation Oncology Danville Virginia United States 24541
    34 Massey Cancer Center Richmond Virginia United States 23298-0037
    35 Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee Wisconsin United States 53295
    36 Royal Prince Alfred Hospital Medical Center Sydney New South Wales Australia 2042
    37 Queensland Radium Institute Herston Queensland Australia 4029
    38 Peter MacCallum Cancer Institute East Melbourne Victoria Australia 8006
    39 Austin and Repatriation Medical Centre Heidelberg West Victoria Australia 3081
    40 Institut Jules Bordet Brussels (Bruxelles) Belgium 1000
    41 Academisch Ziekenhuis der Vrije Universiteit Brussel Brussels (Bruxelles) Belgium 1090
    42 UZ De Pintelaan Gent Belgium B-9000
    43 U.Z. Gasthuisberg Leuven Belgium B-3000
    44 Tom Baker Cancer Center - Calgary Calgary Alberta Canada T2N 4N2
    45 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    46 British Columbia Cancer Agency - Fraser Valley Cancer Centre Surrey British Columbia Canada V3V 1Z2
    47 British Columbia Cancer Agency Vancouver British Columbia Canada V5Z 4E6
    48 St. Boniface General Hospital Winnipeg Manitoba Canada R2H 2A6
    49 Newfoundland Cancer Treatment and Research Foundation St. Johns Newfoundland and Labrador Canada A1B 3V6
    50 Nova Scotia Cancer Centre Halifax Nova Scotia Canada B3H 1V7
    51 Ottawa Regional Cancer Centre Ottawa Ontario Canada K1H 1C4
    52 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
    53 CHUS-Hopital Fleurimont Fleurimont Quebec Canada J1H 5N4
    54 Maisonneuve-Rosemont Hospital Montreal Quebec Canada H1T 2M4
    55 Centre Hospitalier de l'Universite de Montreal Montreal Quebec Canada H2L-4M1
    56 McGill University Montreal Quebec Canada H2W 1S6
    57 Centre Hospitalier Universitaire de Quebec Quebec City Quebec Canada G1R 2J6
    58 Allan Blair Cancer Centre Regina Saskatchewan Canada S4T 7T1
    59 Centre de Lutte Contre le Cancer, Georges-Francois Leclerc Dijon France 21079
    60 CHU de la Timone Marseille France 13385
    61 Hopital de Montbeliard Montbeliard France 25200
    62 Centre Hospitalier Lyon Sud Pierre Benite France 69310
    63 Radiologische Uniklink Freiburg Germany D-79106
    64 Universitats-Krankenhaus Eppendorf Hamburg Germany D-20246
    65 Uzsoki Hospital Budapest Hungary 1145
    66 University of Debrecen Debrecen Hungary 1389/990TE-
    67 Petz Aladar County Hospital Gydr Hungary h-9024
    68 Borsod-Abauj-Zemplen County Hospital Miskolc Hungary 3501
    69 Szeged University Szeged Hungary H-6720
    70 Centro di Riferimento Oncologico - Aviano Aviano Italy 33081
    71 Istituto Europeo Di Oncologia Milano Italy 20141
    72 Newcastle General Hospital Newcastle Upon Tyne England United Kingdom NE4 6BE
    73 Western General Hospital Edinburgh Scotland United Kingdom EH4 2XU

    Sponsors and Collaborators

    • Spectrum Pharmaceuticals, Inc

    Investigators

    • Study Chair: Edward G. Shaw, MD, Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Spectrum Pharmaceuticals, Inc
    ClinicalTrials.gov Identifier:
    NCT00005887
    Other Study ID Numbers:
    • CDR0000067957
    • ALLOS-RSR13RT-009
    First Posted:
    Aug 29, 2003
    Last Update Posted:
    Aug 23, 2021
    Last Verified:
    Aug 1, 2021
    Keywords provided by Spectrum Pharmaceuticals, Inc
    tumors metastatic to brain
    Additional relevant MeSH terms:
    Brain Neoplasms
    Efaproxiral

    Study Results

    No Results Posted as of Aug 23, 2021