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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


Phase 2
N/A
49 Years
Open (Enrolling)
Both
Sarcoma

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Alberto S. Pappo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Texas Children's Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067154

NCT ID:

NCT00003955

Start Date:

March 2001

Completion Date:

Related Keywords:

  • Sarcoma
  • 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
  • Rhabdomyosarcoma
  • Sarcoma

Name

Location

Baylor College of MedicineHouston, Texas  77030
Roswell Park Cancer InstituteBuffalo, New York  14263
Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania  19104
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Walter Reed Army Medical CenterWashington, District of Columbia  20307-5000
MBCCOP - HawaiiHonolulu, Hawaii  96813
University of Chicago Cancer Research CenterChicago, Illinois  60637
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Cancer Center of Albany Medical CenterAlbany, New York  12208
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Ireland Cancer CenterCleveland, Ohio  44106-5065
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
Children's Hospital of MichiganDetroit, Michigan  48201
Hurley Medical CenterFlint, Michigan  48503
Mount Sinai School of MedicineNew York, New York  10029
Presbyterian HealthcareCharlotte, North Carolina  28233-3549
Rhode Island HospitalProvidence, Rhode Island  02903
Medical City Dallas HospitalDallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders CenterLackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
St. Vincent Hospital and Health Care CenterIndianapolis, Indiana  46260
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Avera Cancer InstituteSioux Falls, South Dakota  57105
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Huntsman Cancer InstituteSalt Lake City, Utah  84112
Marshfield ClinicMarshfield, Wisconsin  54449
David Grant Medical CenterTravis Air Force Base, California  94535
Baptist Hospital of MiamiMiami, Florida  33176-2197
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
Newark Beth Israel Medical CenterNewark, New Jersey  07112
New York Medical CollegeValhalla, New York  10595
University of Texas Medical BranchGalveston, Texas  77555-1329
Naval Medical Center, PortsmouthPortsmouth, Virginia  23708-2197
Deaconess Medical CenterSpokane, Washington  99210-0248
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer CenterOrange, California  92868
Rush University Medical CenterChicago, Illinois  60612-3824
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Long Island Cancer Center at Stony Brook University HospitalStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Scott and White HospitalTemple, Texas  76508
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Madigan Army Medical CenterTacoma, Washington  98431-5048
Sutter Cancer CenterSacramento, California  95816
Eastern Maine Medical CenterBangor, Maine  04401
CCOP - OklahomaTulsa, Oklahoma  74136
Children's Hospital Los AngelesLos Angeles, California  90027-0700
Children's Hospital of Orange CountyOrange, California  92668
Children's Hospital of DenverDenver, Colorado  80218
Children's National Medical CenterWashington, District of Columbia  20010-2970
Children's Mercy HospitalKansas City, Missouri  64108
St. Joseph's Hospital and Medical CenterPaterson, New Jersey  07503
Children's Hospital of ColumbusColumbus, Ohio  43205-2696
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
University of California Davis Cancer CenterSacramento, California  95817
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San DiegoSan Diego, California  92120
Kaiser Permanente Medical Center - Santa ClaraSanta Clara, California  95051-5386
Broward General Medical CenterFort Lauderdale, Florida  33316
Children's Hospital of Southwest FloridaFort Myers, Florida  33908
Joe DiMaggio Children's Hospital at MemorialHollywood, Florida  33021
Nemours Children's ClinicJacksonville, Florida  32207
Miami Children's HospitalMiami, Florida  33155-4069
Florida Hospital Cancer InstituteOrlando, Florida  32804
Nemours Children's Clinic-OrlandoOrlando, Florida  32806
Sacred Heart Children's HospitalPensacola, Florida  32504
All Children's HospitalSt. Petersburg, Florida  33701
St. Mary's HospitalWest Palm Beach, Florida  33407
Children's Memorial Hospital - ChicagoChicago, Illinois  60614
Advocate Hope Children's HospitalOak Lawn, Illinois  60453
Saint Jude Midwest AffiliatePeoria, Illinois  61637
Wesley Medical CenterWichita, Kansas  67214
Children's Hospital of New OrleansNew Orleans, Louisiana  70118
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Maine Children's Cancer ProgramScarborough, Maine  04074-9308
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Floating Hospital for ChildrenBoston, Massachusetts  02111
University of Massachusetts Memorial Medical Center - University CampusWorcester, Massachusetts  01655
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
University of New Mexico Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Schneider Children's HospitalNew Hyde Park, New York  11042
St. Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134-1095
Children's Hospital of Greenville Hospital SystemGreenville, South Carolina  29605
St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Cook Children's Medical Center - Fort WorthFort Worth, Texas  76104
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
Carilion Medical Center for ChildrenRoanoke, Virginia  24029
West Virginia University HospitalsMorgantown, West Virginia  26506-9300
City of Hope Comprehensive Cancer CenterDuarte, California  91010
UCSF Comprehensive Cancer CenterSan Francisco, California  94115
Albert Einstein Clinical Cancer CenterBronx, New York  10461
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Phoenix Children's HospitalPhoenix, Arizona  85016-7710
Southern California Permanente Medical GroupDowney, California  90242
Children's Hospital Central CaliforniaMadera, California  93638-8762
Santa Barbara Cottage HospitalSanta Barbara, California  93102
Medical Center of Central GeorgiaMacon, Georgia  31201
Southern Illinois University School of MedicineSpringfield, Illinois  62794-9658
Kosair Children's HospitalLouisville, Kentucky  40202-3830
Spectrum Health and DeVos Children's HospitalGrand Rapids, Michigan  49503
CCOP - BeaumontRoyal Oak, Michigan  48073-6769
Children's Hospitals and Clinics - MinneapolisMinneapolis, Minnesota  55404
St. Louis Children's HospitalSaint Louis, Missouri  63110
Children's Hospital of OmahaOmaha, Nebraska  68114
Sunrise Hospital and Medical CenterLas Vegas, Nevada  89109-2306
Brookdale University Hospital and Medical CenterBrooklyn, New York  11212
Brooklyn Hospital CenterBrooklyn, New York  11201
Children's Hospital Medical Center of AkronAkron, Ohio  44308
Children's Medical Center - DaytonDayton, Ohio  45404
St. Vincent Mercy Medical CenterToledo, Ohio  43608
Toledo Children's HospitalToledo, Ohio  43601
Forum Health-Tod Childrens HospitalYoungstown, Ohio  44501
Natalie Warren Bryant Cancer CenterTulsa, Oklahoma  74136
Palmetto Health South Carolina Cancer CenterColumbia, South Carolina  29203
East Tennessee Children's HospitalKnoxville, Tennessee  37901
Texas Tech University Health Sciences Center School of MedicineAmarillo, Texas  79106
Children's Hospital of AustinAustin, Texas  78701
Covenant Children's HospitalLubbock, Texas  79410
Children's Hospital of the King's DaughtersNorfolk, Virginia  23507
Bellin Memorial HospitalGreen Bay, Wisconsin  54301
Arizona Cancer Center at University of Arizona Health Sciences CenterTucson, Arizona  85724
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Tulane Cancer Center at Tulane University Hospital and ClinicNew Orleans, Louisiana  70112
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Herbert Irving Comprehensive Cancer Center at Columbia UniversityNew York, New York  10032
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
SUNY Downstate Medical CenterBrooklyn, New York  11203
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
Jonathan Jaques Children's Cancer Center at Miller Children's HospitalLong Beach, California  90801
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
Blank Children's HospitalDes Moines, Iowa  50309
Breslin Cancer Center at Ingham Regional Medical CenterLansing, Michigan  48910
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
Legacy Emanuel Hospital and Health Center & Children's HospitalPortland, Oregon  97227
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Massey Cancer Center at Virginia Commonwealth UniversityRichmond, Virginia  23298-0037
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston DivisionCharleston, West Virginia  25302
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
St. Mary's - Duluth Clinic Cancer CenterDuluth, Minnesota  55805
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
Group Health Central HospitalSeattle, Washington  98104
Lombardi Cancer Center at Georgetown University Medical CenterWashington, District of Columbia  20007
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
New York Weill Cornell Cancer Center at Cornell UniversityNew York, New York  10021
Lucile Packard Children's Hospital at Stanford University Medical CenterPalo Alto, California  95798
Alfred I. duPont Hospital for ChildrenWilmington, Delaware  19803
AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Scottish Rite CampusAtlanta, Georgia  30342
University of South Alabama Cancer Research InstituteMobile, Alabama  36604
Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical CenterLos Angeles, California  90048
Children's Hospital and Research Center at OaklandOakland, California  94609-1809
Kaiser Permanente Medical Center - SacramentoSacramento, California  95825
Children's Hospital and Health Center, San DiegoSan Diego, California  92123-4282
University of Connecticut Comprehensive Cancer Center at University of Connecticut Health CenterFarmington, Connecticut  06360-7106
Shands Cancer Center at the University of Florida Health Science CenterGainesville, Florida  32610-0296
Jackson Memorial HospitalMiami, Florida  33136
St. Joseph's Children's HospitalTampa, Florida  33677-4227
MBCCOP-Medical College of Georgia Cancer CenterAugusta, Georgia  30912-4000
Mountain States Tumor Institute - BoiseBoise, Idaho  83712
University of Illinois Medical CenterChicago, Illinois  60612
Riley Children Cancer Center at Riley Hospital for ChildrenIndianapolis, Indiana  46202-5225
Baystate Regional Cancer Program at Baystate Medical CenterSpringfield, Massachusetts  01107
William Beaumont Hospital - Royal OakRoyal Oak, Michigan  48073-6769
Children's Hospitals and Clinics - MinnesotaSaint Paul, Minnesota  55102
Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
Cancer Institute of New Jersey at Robert Wood Johnson University HospitalNew Brunswick, New Jersey  08903
Valerie Fund Children's Center at Atlantic HealthSummit, New Jersey  07901
Comprehensive Cancer Center at Maimonides Medical CenterBrooklyn, New York  11219
University Hospital at State University of New York - Upstate Medical UniversitySyracuse, New York  13210
Mission HospitalsAsheville, North Carolina  28801
Leo W. Jenkins Cancer Center of University Health Systems of Eastern CarolinaGreenville, North Carolina  27858-4354
Dakota Cancer Institute at Innovis Health - Dakota ClinicFargo, North Dakota  58103-4940
Children's Hospital at Oklahoma University Medical CenterOklahoma City, Oklahoma  73104
Doernbecher Children's Hospital at Oregon Health & Science UniversityPortland, Oregon  97239-3098
Sioux Valley Hospital at University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5039
East Tennessee State University Cancer Center at Johnson City Medical CenterJohnson City, Tennessee  37604
Vanderbilt Children's HospitalNashville, Tennessee  37232-6310
Simmons Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390-9063
Methodist Cancer Center at Methodist Specialty and Transplant HospitalSan Antonio, Texas  78229-3902
MBCCOP - South Texas PediatricsSan Antonio, Texas  78229-3900
Center for Cancer Prevention and Care at Scott and White ClinicTemple, Texas  76508
Mary Bridge Children's Hospital and Health CenterTacoma, Washington  98415-0299
Cabell Huntington HospitalHuntington, West Virginia  25701