Melatonin and Radiation Therapy in Treating Patients With Brain Metastases

Sponsor
Radiation Therapy Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00031967
Collaborator
National Cancer Institute (NCI) (NIH)
234

Study Details

Study Description

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as melatonin may make tumor cells more sensitive to radiation therapy and may protect normal cells from the side effects of radiation therapy.

PURPOSE: Randomized phase II trial to determine the effectiveness of combining melatonin with radiation therapy in treating patients who have brain metastases.

Condition or Disease Intervention/Treatment Phase
  • Drug: therapeutic melatonin
  • Radiation: radiation therapy
Phase 2

Detailed Description

OBJECTIVES:
  • Determine the effect of melatonin, used as radiosensitization/radioprotection, on overall survival and clinical deterioration in patients with brain metastases who are undergoing radiotherapy.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to planned chemotherapy after whole brain irradiation (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo whole brain irradiation once daily 5 days a week for 2 weeks. Patients receive oral melatonin once daily every morning.

  • Arm II: Patients undergo whole brain irradiation as in arm I. Patients receive oral melatonin once daily every evening.

All patients continue on melatonin for 6 months in the absence of disease progression or unacceptable toxicity.

Patients are followed at months 6 and 12 from start of radiotherapy and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 128 patients (64 per treatment arm) will be accrued for this study within 5 months.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Primary Purpose:
Treatment
Official Title:
A Randomized Phase II Study of A.M. and P.M. Melatonin for Brain Metastasis in RPA Class II Patients
Study Start Date :
May 1, 2002
Actual Primary Completion Date :
Mar 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    DISEASE CHARACTERISTICS:
    • Histologically confirmed solid tumor with brain metastasis

    • No germ cell tumors

    • RPA class II with any of the following:

    • At least 65 years of age

    • Extracranial metastases

    • Uncontrolled primary malignancy

    • Ineligible for or unwilling to participate in alternative RTOG stereotactic radiosurgery studies

    PATIENT CHARACTERISTICS:
    Age:
    • See Disease Characteristics
    Performance status:
    • Zubrod 0-1
    Life expectancy:
    • Not specified
    Hematopoietic:
    • Not specified
    Hepatic:
    • Not specified
    Renal:
    • Not specified
    Other:
    • Able to swallow pills

    • Not pregnant

    • Fertile patients must use effective contraception

    PRIOR CONCURRENT THERAPY:
    Biologic therapy:
    • Not specified
    Chemotherapy:
    • More than 30 days since prior chemotherapy

    • Concurrent chemotherapy after whole brain irradiation allowed

    Endocrine therapy:
    • Not specified
    Radiotherapy:
    • See Disease Characteristics

    • No prior radiotherapy to the brain

    Surgery:
    • Not specified

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Comprehensive Cancer Center Birmingham Alabama United States 35294-3300
    2 Comprehensive Cancer Institute of Huntsville Huntsville Alabama United States 35801
    3 MBCCOP - Gulf Coast Mobile Alabama United States 36688
    4 Alabama Oncology, LLC Montgomery Alabama United States 36106-3657
    5 DCH Cancer Treatment Center Tuscaloosa Alabama United States 35401
    6 Foundation for Cancer Research and Education Phoenix Arizona United States 85013
    7 Mount Diablo Medical Center Concord California United States 94524-4110
    8 City of Hope Comprehensive Cancer Center Duarte California United States 91010-3000
    9 Saint Agnes Cancer Center Fresno California United States 93720
    10 California Cancer Center Fresno California United States 93729-5100
    11 Sutter Health West Cancer Research Group Greenbrae California United States 94904
    12 Loma Linda University Medical Center Loma Linda California United States 92354
    13 Veterans Affairs Medical Center - Long Beach Long Beach California United States 90822
    14 Jonsson Comprehensive Cancer Center, UCLA Los Angeles California United States 90025-1781
    15 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90033-0804
    16 CCOP - Bay Area Tumor Institute Oakland California United States 94609-3305
    17 Huntington Cancer Center Pasadena California United States 91105
    18 Robert and Beverly Lewis Family Cancer Care Center Pomona California United States 91767
    19 Radiation Oncology Center - Sacramento Sacramento California United States 95816
    20 Radiation Medical Group, Incorporated San Diego California United States 92101
    21 UCSF Comprehensive Cancer Center San Francisco California United States 94143-0128
    22 O'Connor Hospital San Jose California United States 95128
    23 CCOP - Santa Rosa Memorial Hospital Santa Rosa California United States 95403
    24 David Grant Medical Center Travis Air Force Base California United States 94535
    25 Memorial Hospital Cancer Center Colorado Springs Colorado United States 80909
    26 University of Colorado Cancer Center Denver Colorado United States 80010
    27 Saint Mary's Hospital and Medical Center Grand Junction Colorado United States 81502-1628
    28 Hospital of St. Raphael New Haven Connecticut United States 06511
    29 CCOP - Christiana Care Health Services Newark Delaware United States 19713
    30 University of Florida Health Science Center Gainesville Florida United States 32610-0385
    31 Florida Radiation Oncology Group Jacksonville Florida United States 32207
    32 Health First Holmes Regional Medical Center Melbourne Florida United States 32901-3276
    33 CCOP - Mount Sinai Medical Center Miami Beach Florida United States 33140
    34 Veterans Affairs Medical Center - Miami Miami Florida United States 33125
    35 Sylvester Cancer Center, University of Miami Miami Florida United States 33136
    36 Baptist Hospital of Miami Miami Florida United States 33256-2110
    37 MD Anderson Cancer Center Orlando Orlando Florida United States 32806-2134
    38 Bay Medical Center Panama City Florida United States 32401
    39 Gulf Coast Cancer Treatment Center Panama City Florida United States 32405-4587
    40 Sarasota Radiation and Medical Oncology Center Sarasota Florida United States 34233
    41 Tallahassee Memorial Healthcare Tallahassee Florida United States 32308
    42 H. Lee Moffitt Cancer Center and Research Institute Tampa Florida United States 33612-9497
    43 Emory University Hospital - Atlanta Atlanta Georgia United States 30322
    44 CCOP - Atlanta Regional Atlanta Georgia United States 30342-1701
    45 Medical Center/John B. Amos Community Cancer Center Columbus Georgia United States 31901
    46 Regional Radiation Oncology Center at Rome Rome Georgia United States 30165
    47 MBCCOP - Hawaii Honolulu Hawaii United States 96813
    48 Northwest Community Hospital Arlington Heights Illinois United States 60005
    49 Northwestern Memorial Hospital Chicago Illinois United States 60611
    50 CCOP - Central Illinois Decatur Illinois United States 62526
    51 Ingalls Memorial Hospital Harvey Illinois United States 60426
    52 Loyola University Medical Center Maywood Illinois United States 60153
    53 Lutheran General Cancer Care Center Park Ridge Illinois United States 60068
    54 Methodist Medical Center of Illinois Peoria Illinois United States 61636
    55 St. John's Medical Center Anderson Indiana United States 46016
    56 Bloomington Hospital Bloomington Indiana United States 47402
    57 Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis Indiana United States 46202
    58 Clarian Health Partners Inc. Indianapolis Indiana United States 46206-1367
    59 Regional Cancer Center Indianapolis Indiana United States 46219
    60 Ball Memorial Hospital Muncie Indiana United States 47303-3499
    61 CCOP - Northern Indiana CR Consortium South Bend Indiana United States 46601
    62 Wendt Regional Cancer Center of Finley Hospital Dubuque Iowa United States 52001
    63 Central Baptist Hospital Lexington Kentucky United States 40503
    64 Albert B. Chandler Medical Center, University of Kentucky Lexington Kentucky United States 40536-0084
    65 James Graham Brown Cancer Center Louisville Kentucky United States 40202
    66 Louisville Radiation Oncology Louisville Kentucky United States 40215
    67 Merle M. Mahr Cancer Center Madisonville Kentucky United States 42431
    68 Mary Bird Perkins Cancer Center Baton Rouge Louisiana United States 70809
    69 Tulane University School of Medicine New Orleans Louisiana United States 70112-2699
    70 MBCCOP - LSU Medical Center New Orleans Louisiana United States 70112
    71 CCOP - Ochsner New Orleans Louisiana United States 70121
    72 Maine Medical Center Portland Maine United States 04102
    73 Anne Arundel Oncology Center Annapolis Maryland United States 21401
    74 Marlene and Stewart Greenebaum Cancer Center, University of Maryland Baltimore Maryland United States 21201
    75 Greater Baltimore Medical Center and Cancer Center Baltimore Maryland United States 21204
    76 Harbor Hospital Center Baltimore Maryland United States 21215-1290
    77 Sinai Hospital of Baltimore Baltimore Maryland United States 21215
    78 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland United States 21231-2410
    79 Peninsula Regional Medical Center Salisbury Maryland United States 21801
    80 Dana-Farber Cancer Institute Boston Massachusetts United States 02115
    81 Cape Cod Hospital Hyannis Massachusetts United States 02601
    82 Veterans Affairs Medical Center - Boston (Jamaica Plain) Jamaica Plain Massachusetts United States 02130
    83 CCOP - Ann Arbor Regional Ann Arbor Michigan United States 48106
    84 University of Michigan Comprehensive Cancer Center Ann Arbor Michigan United States 48109-0752
    85 Barbara Ann Karmanos Cancer Institute Detroit Michigan United States 48201-1379
    86 Henry Ford Hospital Detroit Michigan United States 48202
    87 Hurley Medical Center Flint Michigan United States 48503
    88 McLaren Regional Cancer Center Flint Michigan United States 48532-3685
    89 CCOP - Kalamazoo Kalamazoo Michigan United States 49007-3731
    90 Marquette General Hospital Marquette Michigan United States 49855
    91 MidMichigan Medical Center - Midland Midland Michigan United States 48670
    92 CCOP - Beaumont Royal Oak Michigan United States 48073-6769
    93 William Beaumont Hospital Royal Oak Michigan United States 48073
    94 William Beaumont Hospital - Troy Troy Michigan United States 48098
    95 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
    96 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
    97 Ellis Fischel Cancer Center - Columbia Columbia Missouri United States 65203
    98 CCOP - Kansas City Kansas City Missouri United States 64131
    99 Mallinckrodt Institute of Radiology Saint Louis Missouri United States 63108
    100 St. Louis University Health Sciences Center Saint Louis Missouri United States 63110-0250
    101 Cancer Research for the Ozarks Springfield Missouri United States 65807
    102 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65807
    103 CCOP - Montana Cancer Consortium Billings Montana United States 59101
    104 CCOP - Missouri Valley Cancer Consortium Omaha Nebraska United States 68106
    105 Methodist Hospital Cancer Center - Omaha Omaha Nebraska United States 68114
    106 Nebraska Health System Omaha Nebraska United States 68198-7460
    107 CCOP - Southern Nevada Cancer Research Foundation Las Vegas Nevada United States 89106
    108 Norris Cotton Cancer Center Lebanon New Hampshire United States 03756-0002
    109 Elliot Regional Cancer Center Manchester New Hampshire United States 03103
    110 Veterans Affairs Medical Center - East Orange East Orange New Jersey United States 07019
    111 John F. Kennedy Medical Center Edison New Jersey United States 08818
    112 Trinitas Hospital - Jersey Street Campus Elizabeth New Jersey United States 07201
    113 Monmouth Medical Center Long Branch New Jersey United States 07740-6395
    114 South Jersey Regional Cancer Center Millville New Jersey United States 08332
    115 Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Mount Holly New Jersey United States 08060
    116 Cancer Institute of New Jersey New Brunswick New Jersey United States 38103-2807
    117 Newark Beth Israel Medical Center Newark New Jersey United States 07112
    118 Atlantic City Medical Center Pomona New Jersey United States 08240
    119 Valley Hospital Ridgewood New Jersey United States 07450
    120 Community Medical Center Toms River New Jersey United States 08755
    121 St. Francis Medical Center Trenton New Jersey United States 08629
    122 Associated Radiologists, P.A. Warren New Jersey United States 07059
    123 Radiation Oncology Associates of Albuquerque Albuquerque New Mexico United States 87109
    124 Cancer Center of Albany Medical Center Albany New York United States 12208
    125 State University of New York Health Science Center at Brooklyn Brooklyn New York United States 11203
    126 New York Methodist Hospital Brooklyn New York United States 11215
    127 Roswell Park Cancer Institute Buffalo New York United States 14263-0001
    128 Finger Lakes Radiation Oncology Center Clifton Springs New York United States 14432
    129 Mary Imogene Bassett Hospital Cooperstown New York United States 13326
    130 CCOP - North Shore University Hospital Manhasset New York United States 11030
    131 Herbert Irving Comprehensive Cancer Center New York New York United States 10032
    132 Champlain Valley Physicians Hospital Medical Center Plattsburgh New York United States 12901
    133 Vassar Brothers Medical Center Poughkeepsie New York United States 12601
    134 James P. Wilmot Cancer Center Rochester New York United States 14642
    135 CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. Syracuse New York United States 13217
    136 Riverhill Radiation Oncology Yonkers New York United States 10701
    137 Lineberger Comprehensive Cancer Center, UNC Chapel Hill North Carolina United States 27599-7295
    138 Northeast Medical Center Concord North Carolina United States 28025
    139 East Carolina University School of Medicine Greenville North Carolina United States 27858-4354
    140 CCOP - Southeast Cancer Control Consortium Winston-Salem North Carolina United States 27104-4241
    141 Comprehensive Cancer Center at Wake Forest University Winston-Salem North Carolina United States 27157-1082
    142 Trinity Cancer Care Center Minot North Dakota United States 58701
    143 Akron General Medical Center Akron Ohio United States 44302
    144 Akron City Hospital Akron Ohio United States 44304
    145 Christ Hospital Cincinnati Ohio United States 45219
    146 Barrett Cancer Center Cincinnati Ohio United States 45267-0502
    147 Ireland Cancer Center Cleveland Ohio United States 44106-5065
    148 University Hospitals of Cleveland Cleveland Ohio United States 44106
    149 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
    150 CCOP - Columbus Columbus Ohio United States 43206
    151 Arthur G. James Cancer Hospital - Ohio State University Columbus Ohio United States 43210-1240
    152 CCOP - Dayton Dayton Ohio United States 45429
    153 Newark Radiation Oncology Newark Ohio United States 43055
    154 CCOP - Toledo Community Hospital Toledo Ohio United States 43623-3456
    155 St. Anthony Hospital Oklahoma City Oklahoma United States 73101
    156 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
    157 St. John Health System Tulsa Oklahoma United States 74104
    158 CCOP - Oklahoma Tulsa Oklahoma United States 74136
    159 CCOP - Columbia River Program Portland Oregon United States 97225
    160 Lehigh Valley Hospital Allentown Pennsylvania United States 18105
    161 St. Luke's Hospital Cancer Center Bethlehem Pennsylvania United States 18015
    162 Geisinger Medical Center Danville Pennsylvania United States 17822-2001
    163 Mercy Fitzgerald Hospital Darby Pennsylvania United States 19023
    164 Delaware County Memorial Hospital Drexel Hill Pennsylvania United States 19026
    165 Pocono Cancer Center East Stroudsburg Pennsylvania United States 18301
    166 Milton S. Hershey Medical Center Hershey Pennsylvania United States 17033-0850
    167 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104-4283
    168 Veterans Affairs Medical Center - Philadelphia Philadelphia Pennsylvania United States 19104
    169 Kimmel Cancer Center of Thomas Jefferson University - Philadelphia Philadelphia Pennsylvania United States 19107-5541
    170 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    171 Albert Einstein Cancer Center Philadelphia Pennsylvania United States 19141-3098
    172 University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania United States 15213-3489
    173 Mercy Hospital of Pittsburgh Pittsburgh Pennsylvania United States 15219
    174 Western Pennsylvania Hospital Pittsburgh Pennsylvania United States 15224
    175 Reading Hospital and Medical Center Reading Pennsylvania United States 19612-6052
    176 Mercy Hospital Cancer Center - Scranton Scranton Pennsylvania United States 18501
    177 Wilkes Barre General Hospital Wilkes-Barre Pennsylvania United States 18764
    178 York Cancer Center York Pennsylvania United States 17403
    179 Roger Williams Medical Center/BUSM Providence Rhode Island United States 02908-4735
    180 CCOP - Greenville Greenville South Carolina United States 29615
    181 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
    182 Jackson-Madison County General Hospital Jackson Tennessee United States 38301-3956
    183 University of Tennessee Cancer Institute Memphis Tennessee United States 38103
    184 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232-5671
    185 Harrington Cancer Center Amarillo Texas United States 79106
    186 University of Texas Medical Branch Galveston Texas United States 77555-0209
    187 University of Texas - MD Anderson Cancer Center Houston Texas United States 77030-4009
    188 Wilford Hall Medical Center Lackland Air Force Base Texas United States 78236-5300
    189 Joe Arrington Cancer Research and Treatment Center Lubbock Texas United States 79410-1894
    190 Dixie Regional Medical Center Saint George Utah United States 84770
    191 University of Utah Health Sciences Center Salt Lake City Utah United States 84132
    192 Latter Day Saints Hospital Salt Lake City Utah United States 84143
    193 Vermont Cancer Center Burlington Vermont United States 05405-0075
    194 Cancer Center at the University of Virginia Charlottesville Virginia United States 22908
    195 RMH Regional Cancer Center Harrisonburg Virginia United States 22801
    196 Naval Medical Center, Portsmouth Portsmouth Virginia United States 23708-2197
    197 Bon Secours - St. Mary's Hospital Richmond Virginia United States 23226
    198 Massey Cancer Center Richmond Virginia United States 23298-0058
    199 Virginia Mason Medical Center Seattle Washington United States 98111
    200 Deaconess Medical Center Spokane Washington United States 99204
    201 Yakima Valley Memorial Hospital Yakima Washington United States 98902
    202 Schiffler Cancer Center Wheeling West Virginia United States 26003
    203 CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay Wisconsin United States 54301
    204 St. Vincent Hospital Green Bay Wisconsin United States 54307-3508
    205 Gundersen Lutheran Medical Foundation La Crosse Wisconsin United States 54601
    206 Southern Wisconsin Radiotherapy Center Madison Wisconsin United States 53713
    207 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792
    208 Marshfield Clinic Marshfield Wisconsin United States 54449
    209 Community Memorial Hospital Menomonee Falls Wisconsin United States 53051
    210 Columbia Hospital Milwaukee Wisconsin United States 53211
    211 St. Luke's Medical Center Milwaukee Wisconsin United States 53215
    212 Medical College of Wisconsin Milwaukee Wisconsin United States 53226
    213 Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee Wisconsin United States 53295
    214 All Saints Cancer Center Racine Wisconsin United States 53405
    215 Waukesha Memorial Hospital Regional Cancer Center Waukesha Wisconsin United States 53188
    216 Tom Baker Cancer Center - Calgary Calgary Alberta Canada T2N 4N2
    217 Cross Cancer Institute Edmonton Alberta Canada T6G 1Z2
    218 Saint John Regional Hospital Saint John New Brunswick Canada E2L 4L2
    219 Newfoundland Cancer Treatment and Research Foundation St. Johns Newfoundland and Labrador Canada A1B 3V6
    220 Nova Scotia Cancer Centre Halifax Nova Scotia Canada B3H 1V7
    221 Cancer Care Ontario-Hamilton Regional Cancer Centre Hamilton Ontario Canada L8V 5C2
    222 Kingston Regional Cancer Centre Kingston Ontario Canada K7L 5P9
    223 Cancer Care Ontario-London Regional Cancer Centre London Ontario Canada N6A 4L6
    224 Ottawa Regional Cancer Centre Ottawa Ontario Canada K1H 1C4
    225 Northeastern Ontario Regional Cancer Centre, Sudbury Sudbury Ontario Canada P3E 5J1
    226 Northwestern Ontario Regional Cancer Centre, Thunder Bay Thunder Bay Ontario Canada P7A 7T1
    227 Toronto Sunnybrook Regional Cancer Centre Toronto Ontario Canada M4N 3M5
    228 Princess Margaret Hospital Toronto Ontario Canada M5G 2M9
    229 CHUS-Hopital Fleurimont Fleurimont Quebec Canada J1H 5N4
    230 Centre Hospitalier de l'Universite de Montreal Montreal Quebec Canada H2L 4MI
    231 McGill University Montreal Quebec Canada H2W 1S6
    232 Centre Hospitalier Universitaire de Quebec Quebec City Quebec Canada G1R 2J6
    233 Allan Blair Cancer Centre Regina Saskatchewan Canada S4T 7T1
    234 Saskatoon Cancer Centre Saskatoon Saskatchewan Canada S7N 4H4

    Sponsors and Collaborators

    • Radiation Therapy Oncology Group
    • National Cancer Institute (NCI)

    Investigators

    • Study Chair: Lawrence B. Berk, MD, PhD, Newark Radiation Oncology

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Radiation Therapy Oncology Group
    ClinicalTrials.gov Identifier:
    NCT00031967
    Other Study ID Numbers:
    • RTOG-BR-0119
    • CDR0000069245
    First Posted:
    Jan 27, 2003
    Last Update Posted:
    Oct 22, 2020
    Last Verified:
    Nov 1, 2013
    Keywords provided by Radiation Therapy Oncology Group
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 22, 2020