AzTrials
AzTrials

SarcomaPhase 2NCT00003955

Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Metastatic Rhabdomyosarcoma or Sarcoma

A Phase 2 study testing dactinomycin, filgrastim and pegfilgrastim in people with Sarcoma, run by Children's Oncology Group at 237 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells. Read more about this study

Who is it for?
Ages Up to 49 years
Conditions the study is for
Sarcoma
What is being tested?
dactinomycin, filgrastim and pegfilgrastim
Type of treatment
Surgery or procedure
How many people
77 participants
Where
237 sitesin 7 countries
Study dates
Sep 1999to Oct 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 49 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic stage IV/clinical group IV rhabdomyosarcoma, undifferentiated sarcoma, or ectomesenchymoma
  • No metastatic embryonal tumors in patients under 10 years of age, regardless of primary site
  • Metastatic tumors of parameningeal sites eligible
  • Bidimensionally measurable disease
  • No positive cerebrospinal fluid cytology or multiple intracranial metastases
  • Patients presenting with the following are only eligible for continuation therapy and may not receive irinotecan/vincristine upfront window therapy:
  • Evidence of base of skull erosion or skull metastatic disease that displaces or indents the dura, compresses the brain parenchyma, or causes evidence of cranial nerve palsy
  • Tumor that touches or displaces the spinal cord
  • Evidence of intracranial primary tumor extension
  • Tumors that could cause potentially life-threatening complications (e.g., renal, airway) with progression due to location and/or growth rate
  • Requires emergency radiotherapy
  • Lab values are consistent with disseminated intravascular coagulation

PATIENT CHARACTERISTICS:

Age:

  • Under 50 (alveolar rhabdomyosarcoma, undifferentiated sarcoma, and ectomesenchymoma patients)
  • 10 to 49 (embryonal histology patients)

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • See Disease Characteristics
  • Absolute neutrophil count greater than 1,000/mm^3*
  • Platelet count greater than 150,000/mm^3* NOTE: *Unless there is tumor involvement of bone marrow

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • PT, PTT, and fibrinogen less than 1.5 times upper limit of normal

Renal:

  • Creatinine less than 1.2 mg/dL

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Prior steroids allowed

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy

Surgery:

  • No more than 42 days since prior initial surgical procedure, including biopsy for diagnosis

Trial locations and contacts

237 sites in 7 countries.

237 sites in 7 countries

United States209 sites

  • Children's Hospital Medical Center of Akron

    Akron, Ohio, 44308

  • Cancer Center of Albany Medical Center

    Albany, New York, 12208

  • University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131

  • Texas Tech University Health Sciences Center School of Medicine

    Amarillo, Texas, 79106

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109-0914

  • Mission Hospitals

    Asheville, North Carolina, 28801

  • AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite Campus

    Atlanta, Georgia, 30342

  • MBCCOP-Medical College of Georgia Cancer Center

    Augusta, Georgia, 30912-4000

  • Children's Hospital of Austin

    Austin, Texas, 78701

  • Greenebaum Cancer Center at University of Maryland Medical Center

    Baltimore, Maryland, 21201-1595

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21225

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • University of Alabama at Birmingham Comprehensive Cancer Center

    Birmingham, Alabama, 35233

  • Mountain States Tumor Institute - Boise

    Boise, Idaho, 83712

  • Floating Hospital for Children

    Boston, Massachusetts, 02111

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Brooklyn Hospital Center

    Brooklyn, New York, 11201-5493

  • SUNY Downstate Medical Center

    Brooklyn, New York, 11203

  • Brookdale University Hospital and Medical Center

    Brooklyn, New York, 11212

  • Comprehensive Cancer Center at Maimonides Medical Center

    Brooklyn, New York, 11219

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263-0001

  • Vermont Cancer Center at University of Vermont

    Burlington, Vermont, 05401-3498

  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

    Chapel Hill, North Carolina, 27599-7295

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolina, 29425-0721

  • West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division

    Charleston, West Virginia, 25302

  • Blumenthal Cancer Center at Carolinas Medical Center

    Charlotte, North Carolina, 28232-2861

  • Presbyterian Healthcare

    Charlotte, North Carolina, 28233

  • Cancer Center at the University of Virginia

    Charlottesville, Virginia, 22908

  • University of Chicago Cancer Research Center

    Chicago, Illinois, 60601

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University of Illinois Medical Center

    Chicago, Illinois, 60612

  • Children's Memorial Hospital - Chicago

    Chicago, Illinois, 60614

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229-3039

  • Ireland Cancer Center

    Cleveland, Ohio, 44106-5065

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Palmetto Health South Carolina Cancer Center

    Columbia, South Carolina, 29203

  • Children's Hospital of Columbus

    Columbus, Ohio, 43205-2696

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas

    Dallas, Texas, 75390-9063

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-1320

  • Children's Medical Center - Dayton

    Dayton, Ohio, 45404

  • Children's Hospital of Denver

    Denver, Colorado, 80218-1088

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • Blank Children's Hospital

    Des Moines, Iowa, 50308

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Children's Hospital of Michigan

    Detroit, Michigan, 48201

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • Van Elslander Cancer Center at St. John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Southern California Permanente Medical Group

    Downey, California, 90242

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • St. Mary's - Duluth Clinic Cancer Center

    Duluth, Minnesota, 55805

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042-3300

  • Dakota Cancer Institute at Innovis Health - Dakota Clinic

    Fargo, North Dakota, 58103-4940

  • University of Connecticut Comprehensive Cancer Center at University of Connecticut Health Center

    Farmington, Connecticut, 06360-7106

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Broward General Medical Center

    Fort Lauderdale, Florida, 33316

  • Children's Hospital of Southwest Florida

    Fort Myers, Florida, 33908

  • Cook Children's Medical Center - Fort Worth

    Fort Worth, Texas, 76104

  • Shands Cancer Center at the University of Florida Health Science Center

    Gainesville, Florida, 32610-0296

  • University of Texas Medical Branch

    Galveston, Texas, 77555-0361

  • Spectrum Health and DeVos Children's Hospital

    Grand Rapids, Michigan, 49503

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301

  • CCOP - St. Vincent Hospital Cancer Center, Green Bay

    Green Bay, Wisconsin, 54301

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54307-9070

  • Leo W. Jenkins Cancer Center of University Health Systems of Eastern Carolina

    Greenville, North Carolina, 27858-4354

  • Children's Hospital of Greenville Hospital System

    Greenville, South Carolina, 29605

  • Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Joe DiMaggio Children's Hospital at Memorial

    Hollywood, Florida, 33021

  • Cancer Research Center of Hawaii

    Honolulu, Hawaii, 96813

  • MBCCOP - Hawaii

    Honolulu, Hawaii, 96813

  • Tripler Army Medical Center

    Honolulu, Hawaii, 96859-5000

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Cabell Huntington Hospital

    Huntington, West Virginia, 25701

  • Riley Children Cancer Center at Riley Hospital for Children

    Indianapolis, Indiana, 46202-5225

  • St. Vincent Hospital and Health Care Center

    Indianapolis, Indiana, 46260

  • Holden Comprehensive Cancer Center at University of Iowa

    Iowa City, Iowa, 52242-1009

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216-4505

  • Nemours Children's Clinic

    Jacksonville, Florida, 32207

  • East Tennessee State University Cancer Center at Johnson City Medical Center

    Johnson City, Tennessee, 37604

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007-5364

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • East Tennessee Children's Hospital

    Knoxville, Tennessee, 37901

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Rebecca and John Moores UCSD Cancer Center

    La Jolla, California, 92093-0658

  • San Antonio Military Pediatric Cancer and Blood Disorders Center

    Lackland Air Force Base, Texas, 78236

  • Breslin Cancer Center at Ingham Regional Medical Center

    Lansing, Michigan, 48910

  • Sunrise Hospital and Medical Center

    Las Vegas, Nevada, 89109

  • Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0284

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Loma Linda University Cancer Institute at Loma Linda University Medical Center

    Loma Linda, California, 92354

  • Jonathan Jaques Children's Cancer Center at Miller Children's Hospital

    Long Beach, California, 90801-1428

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027-0700

  • Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Jonsson Comprehensive Cancer Center, UCLA

    Los Angeles, California, 90095-1781

  • Kosair Children's Hospital

    Louisville, Kentucky, 40202-3830

  • Covenant Children's Hospital

    Lubbock, Texas, 79410

  • Medical Center of Central Georgia

    Macon, Georgia, 31201

  • Children's Hospital Central California

    Madera, California, 93638-8762

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792-6164

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449-5772

  • CCOP - Marshfield Clinic Research Foundation

    Marshfield, Wisconsin, 54449

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105-2794

  • Jackson Memorial Hospital

    Miami, Florida, 33136

  • Miami Children's Hospital

    Miami, Florida, 33155

  • Baptist Hospital of Miami

    Miami, Florida, 33176-2197

  • Midwest Children's Cancer Center

    Milwaukee, Wisconsin, 53226

  • Children's Hospitals and Clinics - Minneapolis

    Minneapolis, Minnesota, 55404

  • University of South Alabama Cancer Research Institute

    Mobile, Alabama, 36604

  • West Virginia University Hospitals

    Morgantown, West Virginia, 26506-9300

  • Vanderbilt Children's Hospital

    Nashville, Tennessee, 37232-6310

  • Cancer Institute of New Jersey at Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08903

  • Yale Comprehensive Cancer Center

    New Haven, Connecticut, 06520-8028

  • Schneider Children's Hospital

    New Hyde Park, New York, 11042

  • MBCCOP - LSU Health Sciences Center

    New Orleans, Louisiana, 70112

  • Tulane Cancer Center at Tulane University Hospital and Clinic

    New Orleans, Louisiana, 70112

  • Children's Hospital of New Orleans

    New Orleans, Louisiana, 70118

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Memorial Sloan-Kettering Cancer Center

    New York, New York, 10021

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York, 10021

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Herbert Irving Comprehensive Cancer Center at Columbia University

    New York, New York, 10032

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112-2094

  • Children's Hospital of the King's Daughters

    Norfolk, Virginia, 23507

  • Advocate Hope Children's Hospital

    Oak Lawn, Illinois, 60453

  • Children's Hospital and Research Center at Oakland

    Oakland, California, 94609-1809

  • Children's Hospital at Oklahoma University Medical Center

    Oklahoma City, Oklahoma, 73104

  • Children's Hospital of Omaha

    Omaha, Nebraska, 68114

  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center

    Omaha, Nebraska, 68198-2168

  • Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center

    Orange, California, 92868

  • Children's Hospital of Orange County

    Orange, California, 92868

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Nemours Children's Clinic-Orlando

    Orlando, Florida, 32806

  • Lucile Packard Children's Hospital at Stanford University Medical Center

    Palo Alto, California, 94304

  • Lutheran General Cancer Care Center

    Park Ridge, Illinois, 60068-1174

  • St. Joseph's Hospital and Medical Center

    Paterson, New Jersey, 07503

  • Sacred Heart Children's Hospital

    Pensacola, Florida, 32504

  • Saint Jude Midwest Affiliate

    Peoria, Illinois, 61637

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

  • St. Christopher's Hospital for Children

    Philadelphia, Pennsylvania, 19134-1095

  • Phoenix Children's Hospital

    Phoenix, Arizona, 85016

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15213-2583

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Legacy Emanuel Hospital and Health Center & Children's Hospital

    Portland, Oregon, 97227

  • Doernbecher Children's Hospital at Oregon Health & Science University

    Portland, Oregon, 97239-3098

  • Naval Medical Center, Portsmouth

    Portsmouth, Virginia, 23708-5100

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Massey Cancer Center at Virginia Commonwealth University

    Richmond, Virginia, 23298-0121

  • Carilion Medical Center for Children

    Roanoke, Virginia, 24029

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642

  • CCOP - Beaumont

    Royal Oak, Michigan, 48073-6769

  • William Beaumont Hospital - Royal Oak

    Royal Oak, Michigan, 48073-6769

  • Sutter Cancer Center

    Sacramento, California, 95816

  • University of California Davis Cancer Center

    Sacramento, California, 95817

  • Kaiser Permanente Medical Center - Sacramento

    Sacramento, California, 95825

  • Children's Hospitals and Clinics - Minnesota

    Saint Paul, Minnesota, 55102

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78207

  • MBCCOP - South Texas Pediatrics

    San Antonio, Texas, 78229-3900

  • Methodist Cancer Center at Methodist Specialty and Transplant Hospital

    San Antonio, Texas, 78229-3902

  • Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego

    San Diego, California, 92120

  • Children's Hospital and Health Center, San Diego

    San Diego, California, 92123-4282

  • UCSF Comprehensive Cancer Center

    San Francisco, California, 94115

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93102

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051-5386

  • Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

    Savannah, Georgia, 31405

  • Maine Children's Cancer Program

    Scarborough, Maine, 04074-9308

  • Children's Hospital and Regional Medical Center - Seattle

    Seattle, Washington, 98105

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109-1024

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105-1080

  • Sioux Valley Hospital at University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • Deaconess Medical Center

    Spokane, Washington, 99210-0248

  • Southern Illinois University School of Medicine

    Springfield, Illinois, 62794-9658

  • Baystate Regional Cancer Program at Baystate Medical Center

    Springfield, Massachusetts, 01107

  • Cardinal Glennon Children's Hospital

    St Louis, Missouri, 63104

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110

  • All Children's Hospital

    St. Petersburg, Florida, 33701

  • Long Island Cancer Center at Stony Brook University Hospital

    Stony Brook, New York, 11794

  • Valerie Fund Children's Center at Atlantic Health

    Summit, New Jersey, 07901

  • University Hospital at State University of New York - Upstate Medical University

    Syracuse, New York, 13210

  • Mary Bridge Children's Hospital and Health Center

    Tacoma, Washington, 98415-0299

  • Madigan Army Medical Center

    Tacoma, Washington, 98431-5000

  • St. Joseph's Children's Hospital

    Tampa, Florida, 33677-4227

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Center for Cancer Prevention and Care at Scott and White Clinic

    Temple, Texas, 76508

  • Albert Einstein Clinical Cancer Center

    The Bronx, New York, 10461

  • Toledo Children's Hospital

    Toledo, Ohio, 43601

  • St. Vincent Mercy Medical Center

    Toledo, Ohio, 43608

  • David Grant Medical Center

    Travis Air Force Base, California, 94535

  • Arizona Cancer Center at University of Arizona Health Sciences Center

    Tucson, Arizona, 85724

  • CCOP - Oklahoma

    Tulsa, Oklahoma, 74136

  • Natalie Warren Bryant Cancer Center

    Tulsa, Oklahoma, 74136

  • New York Medical College

    Valhalla, New York, 10595

  • Lombardi Cancer Center at Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

  • Children's National Medical Center

    Washington D.C., District of Columbia, 20010-2970

  • Walter Reed Army Medical Center

    Washington D.C., District of Columbia, 20307-5001

  • St. Mary's Hospital

    West Palm Beach, Florida, 33407

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Alfred I. duPont Hospital for Children

    Wilmington, Delaware, 19899

  • Comprehensive Cancer Center at Wake Forest University

    Winston-Salem, North Carolina, 27157-1081

  • University of Massachusetts Memorial Medical Center - University Campus

    Worcester, Massachusetts, 01655

  • Forum Health-Tod Childrens Hospital

    Youngstown, Ohio, 44501

Other trials in United States

Canada15 sites

  • Alberta Children's Hospital

    Calgary, Alberta, T2T 5C7

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • IWK Health Centre

    Halifax, Nova Scotia, B3J 3G9

  • McMaster Children's Hospital at Hamilton Health Sciences

    Hamilton, Ontario, L8N 3Z5

  • Children's Hospital of Western Ontario

    London, Ontario, N6C 2V5

  • McGill University Health Center - Montreal Children's Hospital

    Montreal, Quebec, H3G 1A4

  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Allan Blair Cancer Centre at Pasqua Hospital

    Regina, Saskatchewan, S4T 7T1

  • Centre de Recherche du Centre Hospitalier de l'Universite Laval

    Sainte-Foy, Quebec, GIV 4G2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Janeway Children's Health and Rehabilitation Centre

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

  • British Columbia Children's Hospital

    Vancouver, British Columbia, V6H 3V4

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Australia6 sites

  • Royal Children's Hospital

    Brisbane, Queensland, 4029

  • Women's and Children's Hospital

    North Adelaide, South Australia, 5006

  • Royal Children's Hospital

    Parkville, Victoria, 3052

  • Princess Margaret Hospital for Children

    Perth, Western Australia, 6001

  • Sydney Children's Hospital

    Randwick, New South Wales, 2031

  • Children's Hospital at Westmead

    Westmead, New South Wales, 2145

Other trials in Australia

Switzerland3 sites

  • Swiss Pediatric Oncology Group Bern

    Bern, CH 3010

  • Swiss Pediatric Oncology Group Geneva

    Geneva, CH 1211

  • Swiss Pediatric Oncology Group Lausanne

    Lausanne, CH 1011

Other trials in Switzerland

Puerto Rico2 sites

  • Puerto Rico Cancer Center at University of Puerto Rico - Medical Sciences Campus

    San Juan, 00936-5067

  • San Jorge Childrens Hospital

    Santurce, 00912

Other trials in Puerto Rico

Netherlands1 site

  • Academisch Ziekenhuis Groningen

    Groningen, 9700 RB

Other trials in Netherlands

New Zealand1 site

  • Starship Children's Hospital

    Auckland

Other trials in New Zealand

About this study

Official title: A Phase II "Up-Front Window Study" of Irinotecan (CPT-11) Followed by Multimodal, Multiagent, Therapy for Selected Children and Adolescents With Newly Diagnosed Stage 4/Clinical Group IV Rhabdomyosarcoma: An IRS-V Study

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with radiation therapy in treating patients who have metastatic rhabdomyosarcoma or sarcoma.

Read the detailed description

OBJECTIVES:

  • Determine the response rate of patients with newly diagnosed high-risk metastatic stage IV/clinical group IV rhabdomyosarcoma treated with upfront window therapy comprising irinotecan and vincristine.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the toxic effects of this regimen when given in alternating courses with vincristine, dactinomycin, and cyclophosphamide (VAC) as continuation therapy in patients with partial or complete response.
  • Determine the overall and failure-free survival of patients treated with irinotecan and vincristine followed by VAC alone or VAC alternating with vincristine and irinotecan plus radiotherapy.
  • Determine the pharmacokinetics of irinotecan and vincristine in these patients.

OUTLINE:

  • Upfront window therapy: Patients receive vincristine IV on days 1 and 8 and irinotecan IV over 60 minutes on days 1-5 and 8-12. Treatment repeats every 21 days for a total of 2 courses. Patients experiencing partial or complete response proceed to regimen A. Patients experiencing stable or progressive disease proceed to regimen B.
  • Regimen A: Patients receive vincristine IV over 1 minute weekly on weeks 6-13, 15-19, 23-27, 29, 32-35, 38-39, and 41; dactinomycin IV over 1 minute weekly on weeks 6, 12, 23, 29, 35, and 41; and cyclophosphamide IV over 30-60 minutes weekly on weeks 6, 12, 16, 19, 23, 29, 35, and 41. Patients also receive irinotecan IV over 1 hour daily, 5 days a week, on weeks 9, 10, 26, 27, 32, 33, 38, and 39 and undergo radiotherapy daily, 5 days a week, on weeks 15-22.
  • Regimen B: Patients receive vincristine as in regimen A; dactinomycin IV over 1 minute weekly on weeks 6, 9, 12, 23, 26, 29, 32, 35, 38, and 41 and cyclophosphamide IV over 30-60 minutes weekly on weeks 6, 9, 12, 16, 19, 23, 26, 29, 32, 35, 38, and 41. Patients receive radiotherapy as in regimen A.

Patients who do not receive upfront window irinotecan/vincristine therapy are treated with standard therapy.

  • Standard therapy: Patients receive vincristine IV over 1 minute weekly on weeks 0-13, 15-19, 23-27, 29, 32-35, 38, and 41; dactinomycin IV over 1 minute weekly on weeks 0, 6, 9, 12, 23, 26, 29, 32, 35, 38, and 41; and cyclophosphamide IV over 30-60 minutes weekly on weeks 0, 3, 6, 9, 12, 16, 19, 23, 26, 29, 32, 35, 38, and 41. Patients without evidence of intracranial extension receive radiotherapy once daily, 5 days a week, during weeks 15-22. Patients with evidence of intracranial extension, or who require emergency radiotherapy, receive radiotherapy during weeks 0-6. Dactinomycin is withheld during radiotherapy.

All patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously (SC) beginning 24 hours after completion of each course of chemotherapy and continuing until blood counts recover. Alternatively, patients may receive pegfilgrastim SC beginning 24-36 hours after completion of each course of chemotherapy and continuing until blood counts recover.

Patients are followed every 2 months for 1 year, every 4 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 18-46 patients will be accrued for this study within 9-24 months.

Conditions
Sarcoma
Keywords
embryonal childhood rhabdomyosarcoma, alveolar childhood rhabdomyosarcoma, metastatic childhood soft tissue sarcoma, childhood malignant mesenchymoma, previously untreated childhood rhabdomyosarcoma, adult rhabdomyosarcoma, adult malignant mesenchymoma, stage IV adult soft tissue sarcoma
Medical subject headings
Sarcoma, Malignant mesenchymal tumor, Rhabdomyosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Event Free Survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startSep 1999
  3. Primary completionJan 2005
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00003955
Sponsor's protocol ID
D9802
Other IDs
COG-D9802, IRS-D9802, CCG-D9802, POG-D9802, CDR0000067154
Status last verified
Feb 2014
First submitted
1 Nov 1999
Last updated
14 Feb 2014
Results posted
No

Publications

  • Soft Tissue Sarcoma Committee of the Children's Oncology Group; Lager JJ, Lyden ER, Anderson JR, Pappo AS, Meyer WH, Breitfeld PP. Pooled analysis of phase II window studies in children with contemporary high-risk metastatic rhabdomyosarcoma: a report from the Soft Tissue Sarcoma Committee of the Children's Oncology Group. J Clin Oncol. 2006 Jul 20;24(21):3415-22. doi: 10.1200/JCO.2005.01.9497.

    PubMed 16849756

  • Pappo AS, Lyden E, Breitfeld P, Donaldson SS, Wiener E, Parham D, Crews KR, Houghton P, Meyer WH; Children's Oncology Group. Two consecutive phase II window trials of irinotecan alone or in combination with vincristine for the treatment of metastatic rhabdomyosarcoma: the Children's Oncology Group. J Clin Oncol. 2007 Feb 1;25(4):362-9. doi: 10.1200/JCO.2006.07.1720.

    PubMed 17264331

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing dactinomycin, filgrastim and pegfilgrastim in people with Sarcoma, run by Children's Oncology Group at 237 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 237 sites in United States, Canada, Australia, Switzerland, Puerto Rico and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Event Free Survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00003955, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2014.

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