Melatonin and Radiation Therapy in Treating Patients With Brain Metastases

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

A Randomized Phase II Study of A.M. and P.M. Melatonin for Brain Metastasis in RPA Class II Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00031967
• Other study ID #: RTOG-BR-0119
• Secondary ID: CDR0000069245
• Status: Completed
• Phase: Phase 2
• Start date: May 2002

Study information

• Verified date: November 2013
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Radiation Toxicity
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Drug:
• therapeutic melatonin

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Center - Calgary	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	CHUS-Hopital Fleurimont	Fleurimont	Quebec
Canada	Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	Cancer Care Ontario-Hamilton Regional Cancer Centre	Hamilton	Ontario
Canada	Kingston Regional Cancer Centre	Kingston	Ontario
Canada	Cancer Care Ontario-London Regional Cancer Centre	London	Ontario
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	McGill University	Montreal	Quebec
Canada	Ottawa Regional Cancer Centre	Ottawa	Ontario
Canada	Centre Hospitalier Universitaire de Quebec	Quebec City	Quebec
Canada	Allan Blair Cancer Centre	Regina	Saskatchewan
Canada	Saint John Regional Hospital	Saint John	New Brunswick
Canada	Saskatoon Cancer Centre	Saskatoon	Saskatchewan
Canada	Newfoundland Cancer Treatment and Research Foundation	St. Johns	Newfoundland and Labrador
Canada	Northeastern Ontario Regional Cancer Centre, Sudbury	Sudbury	Ontario
Canada	Northwestern Ontario Regional Cancer Centre, Thunder Bay	Thunder Bay	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Toronto Sunnybrook Regional Cancer Centre	Toronto	Ontario
United States	Akron City Hospital	Akron	Ohio
United States	Akron General Medical Center	Akron	Ohio
United States	Cancer Center of Albany Medical Center	Albany	New York
United States	Radiation Oncology Associates of Albuquerque	Albuquerque	New Mexico
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Harrington Cancer Center	Amarillo	Texas
United States	St. John's Medical Center	Anderson	Indiana
United States	CCOP - Ann Arbor Regional	Ann Arbor	Michigan
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan
United States	Anne Arundel Oncology Center	Annapolis	Maryland
United States	Northwest Community Hospital	Arlington Heights	Illinois
United States	CCOP - Atlanta Regional	Atlanta	Georgia
United States	Emory University Hospital - Atlanta	Atlanta	Georgia
United States	Greater Baltimore Medical Center and Cancer Center	Baltimore	Maryland
United States	Harbor Hospital Center	Baltimore	Maryland
United States	Marlene and Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Mary Bird Perkins Cancer Center	Baton Rouge	Louisiana
United States	St. Luke's Hospital Cancer Center	Bethlehem	Pennsylvania
United States	CCOP - Montana Cancer Consortium	Billings	Montana
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Bloomington Hospital	Bloomington	Indiana
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	New York Methodist Hospital	Brooklyn	New York
United States	State University of New York Health Science Center at Brooklyn	Brooklyn	New York
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	Vermont Cancer Center	Burlington	Vermont
United States	Lineberger Comprehensive Cancer Center, UNC	Chapel Hill	North Carolina
United States	Cancer Center at the University of Virginia	Charlottesville	Virginia
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Barrett Cancer Center	Cincinnati	Ohio
United States	Christ Hospital	Cincinnati	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Ireland Cancer Center	Cleveland	Ohio
United States	University Hospitals of Cleveland	Cleveland	Ohio
United States	Finger Lakes Radiation Oncology Center	Clifton Springs	New York
United States	Memorial Hospital Cancer Center	Colorado Springs	Colorado
United States	Ellis Fischel Cancer Center - Columbia	Columbia	Missouri
United States	Arthur G. James Cancer Hospital - Ohio State University	Columbus	Ohio
United States	CCOP - Columbus	Columbus	Ohio
United States	Medical Center/John B. Amos Community Cancer Center	Columbus	Georgia
United States	Mount Diablo Medical Center	Concord	California
United States	Northeast Medical Center	Concord	North Carolina
United States	Mary Imogene Bassett Hospital	Cooperstown	New York
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Mercy Fitzgerald Hospital	Darby	Pennsylvania
United States	CCOP - Dayton	Dayton	Ohio
United States	CCOP - Central Illinois	Decatur	Illinois
United States	University of Colorado Cancer Center	Denver	Colorado
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Henry Ford Hospital	Detroit	Michigan
United States	Delaware County Memorial Hospital	Drexel Hill	Pennsylvania
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Wendt Regional Cancer Center of Finley Hospital	Dubuque	Iowa
United States	Veterans Affairs Medical Center - East Orange	East Orange	New Jersey
United States	Pocono Cancer Center	East Stroudsburg	Pennsylvania
United States	John F. Kennedy Medical Center	Edison	New Jersey
United States	Trinitas Hospital - Jersey Street Campus	Elizabeth	New Jersey
United States	Hurley Medical Center	Flint	Michigan
United States	McLaren Regional Cancer Center	Flint	Michigan
United States	California Cancer Center	Fresno	California
United States	Saint Agnes Cancer Center	Fresno	California
United States	University of Florida Health Science Center	Gainesville	Florida
United States	University of Texas Medical Branch	Galveston	Texas
United States	Saint Mary's Hospital and Medical Center	Grand Junction	Colorado
United States	CCOP - St. Vincent Hospital Cancer Center, Green Bay	Green Bay	Wisconsin
United States	St. Vincent Hospital	Green Bay	Wisconsin
United States	Sutter Health West Cancer Research Group	Greenbrae	California
United States	CCOP - Greenville	Greenville	South Carolina
United States	East Carolina University School of Medicine	Greenville	North Carolina
United States	RMH Regional Cancer Center	Harrisonburg	Virginia
United States	Ingalls Memorial Hospital	Harvey	Illinois
United States	Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	MBCCOP - Hawaii	Honolulu	Hawaii
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas
United States	Comprehensive Cancer Institute of Huntsville	Huntsville	Alabama
United States	Cape Cod Hospital	Hyannis	Massachusetts
United States	Clarian Health Partners Inc.	Indianapolis	Indiana
United States	Regional Cancer Center	Indianapolis	Indiana
United States	Veterans Affairs Medical Center - Indianapolis (Roudebush)	Indianapolis	Indiana
United States	Jackson-Madison County General Hospital	Jackson	Tennessee
United States	Florida Radiation Oncology Group	Jacksonville	Florida
United States	Veterans Affairs Medical Center - Boston (Jamaica Plain)	Jamaica Plain	Massachusetts
United States	CCOP - Kalamazoo	Kalamazoo	Michigan
United States	CCOP - Kansas City	Kansas City	Missouri
United States	Gundersen Lutheran Medical Foundation	La Crosse	Wisconsin
United States	Wilford Hall Medical Center	Lackland Air Force Base	Texas
United States	CCOP - Southern Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	Norris Cotton Cancer Center	Lebanon	New Hampshire
United States	Albert B. Chandler Medical Center, University of Kentucky	Lexington	Kentucky
United States	Central Baptist Hospital	Lexington	Kentucky
United States	Loma Linda University Medical Center	Loma Linda	California
United States	Veterans Affairs Medical Center - Long Beach	Long Beach	California
United States	Monmouth Medical Center	Long Branch	New Jersey
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	James Graham Brown Cancer Center	Louisville	Kentucky
United States	Louisville Radiation Oncology	Louisville	Kentucky
United States	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas
United States	Southern Wisconsin Radiotherapy Center	Madison	Wisconsin
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Merle M. Mahr Cancer Center	Madisonville	Kentucky
United States	Elliot Regional Cancer Center	Manchester	New Hampshire
United States	CCOP - North Shore University Hospital	Manhasset	New York
United States	Marquette General Hospital	Marquette	Michigan
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Loyola University Medical Center	Maywood	Illinois
United States	Health First Holmes Regional Medical Center	Melbourne	Florida
United States	University of Tennessee Cancer Institute	Memphis	Tennessee
United States	Community Memorial Hospital	Menomonee Falls	Wisconsin
United States	Baptist Hospital of Miami	Miami	Florida
United States	Sylvester Cancer Center, University of Miami	Miami	Florida
United States	Veterans Affairs Medical Center - Miami	Miami	Florida
United States	CCOP - Mount Sinai Medical Center	Miami Beach	Florida
United States	MidMichigan Medical Center - Midland	Midland	Michigan
United States	South Jersey Regional Cancer Center	Millville	New Jersey
United States	Columbia Hospital	Milwaukee	Wisconsin
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Veterans Affairs Medical Center - Milwaukee (Zablocki)	Milwaukee	Wisconsin
United States	Trinity Cancer Care Center	Minot	North Dakota
United States	MBCCOP - Gulf Coast	Mobile	Alabama
United States	Alabama Oncology, LLC	Montgomery	Alabama
United States	Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital	Mount Holly	New Jersey
United States	Ball Memorial Hospital	Muncie	Indiana
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Hospital of St. Raphael	New Haven	Connecticut
United States	CCOP - Ochsner	New Orleans	Louisiana
United States	MBCCOP - LSU Medical Center	New Orleans	Louisiana
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Herbert Irving Comprehensive Cancer Center	New York	New York
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Newark Radiation Oncology	Newark	Ohio
United States	CCOP - Bay Area Tumor Institute	Oakland	California
United States	St. Anthony Hospital	Oklahoma City	Oklahoma
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	Methodist Hospital Cancer Center - Omaha	Omaha	Nebraska
United States	Nebraska Health System	Omaha	Nebraska
United States	MD Anderson Cancer Center Orlando	Orlando	Florida
United States	Bay Medical Center	Panama City	Florida
United States	Gulf Coast Cancer Treatment Center	Panama City	Florida
United States	Lutheran General Cancer Care Center	Park Ridge	Illinois
United States	Huntington Cancer Center	Pasadena	California
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Abramson Cancer Center of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Albert Einstein Cancer Center	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center of Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	Veterans Affairs Medical Center - Philadelphia	Philadelphia	Pennsylvania
United States	Foundation for Cancer Research and Education	Phoenix	Arizona
United States	Mercy Hospital of Pittsburgh	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Cancer Institute	Pittsburgh	Pennsylvania
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Champlain Valley Physicians Hospital Medical Center	Plattsburgh	New York
United States	Atlantic City Medical Center	Pomona	New Jersey
United States	Robert and Beverly Lewis Family Cancer Care Center	Pomona	California
United States	CCOP - Columbia River Program	Portland	Oregon
United States	Maine Medical Center	Portland	Maine
United States	Naval Medical Center, Portsmouth	Portsmouth	Virginia
United States	Vassar Brothers Medical Center	Poughkeepsie	New York
United States	Roger Williams Medical Center/BUSM	Providence	Rhode Island
United States	All Saints Cancer Center	Racine	Wisconsin
United States	Reading Hospital and Medical Center	Reading	Pennsylvania
United States	Bon Secours - St. Mary's Hospital	Richmond	Virginia
United States	Massey Cancer Center	Richmond	Virginia
United States	Valley Hospital	Ridgewood	New Jersey
United States	James P. Wilmot Cancer Center	Rochester	New York
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Regional Radiation Oncology Center at Rome	Rome	Georgia
United States	CCOP - Beaumont	Royal Oak	Michigan
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Radiation Oncology Center - Sacramento	Sacramento	California
United States	Dixie Regional Medical Center	Saint George	Utah
United States	Mallinckrodt Institute of Radiology	Saint Louis	Missouri
United States	St. Louis University Health Sciences Center	Saint Louis	Missouri
United States	CCOP - Metro-Minnesota	Saint Louis Park	Minnesota
United States	Peninsula Regional Medical Center	Salisbury	Maryland
United States	Latter Day Saints Hospital	Salt Lake City	Utah
United States	University of Utah Health Sciences Center	Salt Lake City	Utah
United States	Radiation Medical Group, Incorporated	San Diego	California
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	O'Connor Hospital	San Jose	California
United States	CCOP - Santa Rosa Memorial Hospital	Santa Rosa	California
United States	Sarasota Radiation and Medical Oncology Center	Sarasota	Florida
United States	Mercy Hospital Cancer Center - Scranton	Scranton	Pennsylvania
United States	Virginia Mason Medical Center	Seattle	Washington
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	Deaconess Medical Center	Spokane	Washington
United States	Cancer Research for the Ozarks	Springfield	Missouri
United States	CCOP - Cancer Research for the Ozarks	Springfield	Missouri
United States	CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.	Syracuse	New York
United States	Tallahassee Memorial Healthcare	Tallahassee	Florida
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	CCOP - Toledo Community Hospital	Toledo	Ohio
United States	Community Medical Center	Toms River	New Jersey
United States	David Grant Medical Center	Travis Air Force Base	California
United States	St. Francis Medical Center	Trenton	New Jersey
United States	William Beaumont Hospital - Troy	Troy	Michigan
United States	CCOP - Oklahoma	Tulsa	Oklahoma
United States	St. John Health System	Tulsa	Oklahoma
United States	DCH Cancer Treatment Center	Tuscaloosa	Alabama
United States	Associated Radiologists, P.A.	Warren	New Jersey
United States	Waukesha Memorial Hospital Regional Cancer Center	Waukesha	Wisconsin
United States	Schiffler Cancer Center	Wheeling	West Virginia
United States	Wilkes Barre General Hospital	Wilkes-Barre	Pennsylvania
United States	CCOP - Southeast Cancer Control Consortium	Winston-Salem	North Carolina
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina
United States	Yakima Valley Memorial Hospital	Yakima	Washington
United States	Riverhill Radiation Oncology	Yonkers	New York
United States	York Cancer Center	York	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (2)

Berk L, Berkey B, Rich T, Hrushesky W, Blask D, Gallagher M, Kudrimoti M, McGarry RC, Suh J, Mehta M. Randomized phase II trial of high-dose melatonin and radiation therapy for RPA class 2 patients with brain metastases (RTOG 0119). Int J Radiat Oncol Bio — View Citation

Berk L, Seiferheld W, Rich T, et al.: RTOG BR-0119: Chronobiological study of the addition of melatonin to radiotherapy for brain metastases. [Abstract] Neuro-Oncology 6 (4): RT-01, 359, 2004.