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Protocol for Patients With Newly-Diagnosed Non-Metastatic Osteosarcoma - A POG/CCG Pilot Intergroup Study


Phase 3
N/A
30 Years
Not Enrolling
Both
Cardiac Toxicity, Sarcoma

Thank you

Trial Information

Protocol for Patients With Newly-Diagnosed Non-Metastatic Osteosarcoma - A POG/CCG Pilot Intergroup Study


OBJECTIVES: I. Compare the efficacy of three intensification regimens (doxorubicin vs
doxorubicin plus ifosfamide vs doxorubicin plus ifosfamide and etoposide) in patients with
newly diagnosed, previously untreated, nonmetastatic osteosarcoma. II. Determine the effect
of postoperative dose intensification on outcome in patients with standard response to
preoperative chemotherapy. III. Determine the effect of dexrazoxane cardioprotection during
standard induction therapy on histologic response in these patients. IV. Evaluate biological
factors that may predict outcome in these patients. V. Determine the safety of dexrazoxane
administered with doxorubicin in combination with cisplatin or cisplatin and ifosfamide in
these patients. VI. Determine the effect of dexrazoxane on cytotoxicity as measured by tumor
necrosis at definitive surgery in these patients. VII. Assess the feasibility of
administering doxorubicin with dexrazoxane cardioprotection or high dose ifosfamide with
etoposide to standard risk patients who are also receiving methotrexate and cisplatin.

OUTLINE: This is a multicenter study. Patients are enrolled sequentially on 1 of 3 pilot
intensification regimens. After surgery to completely remove the primary tumor, patients are
assigned to 1 of 2 adjuvant chemotherapy groups based on percent necrosis at limb salvage.
Pilot 1: (Closed to accrual as of 6/2/2000) Patients receive dexrazoxane IV followed
immediately by doxorubicin IV over 20 minutes plus cisplatin IV over 4 hours on days 1 and 2
of weeks 1 and 6. Methotrexate IV over 4 hours is administered on day 1 of weeks 4, 5, 9,
and 10. Patients undergo surgery on week 11. Adjuvant chemotherapy begins on day 1 of week
13. Group 1 (good response to neoadjuvant chemotherapy): Patients receive methotrexate IV
over 4 hours every 3 weeks for 6 courses, beginning on week 13. Patients also receive
dexrazoxane and doxorubicin every 3 weeks for 4 courses, beginning on week 14. Cisplatin is
administered with the first 2 courses of dexrazoxane and doxorubicin. Group 2 (standard
response to neoadjuvant chemotherapy): Patients receive methotrexate and cisplatin as in
group 1 plus dexrazoxane and doxorubicin for 6 courses. Pilot 2: Patients receive
preoperative therapy comprised of dexrazoxane, doxorubicin, and methotrexate as in pilot 1.
Ifosfamide IV over 4 hours is also administered on days 1-5 of week 1. Patients undergo
surgery on week 11, then begin adjuvant chemotherapy on week 13. Group 1: Patients receive
methotrexate, dexrazoxane, and doxorubicin as in pilot 1, group 1. Ifosfamide is also
administered on weeks 14 and 20. Cisplatin is administered on weeks 17, 23, and 26. Group 2:
Patients receive methotrexate, dexrazoxane, and doxorubicin as in pilot 1, group 2.
Ifosfamide is administered on weeks 14, 20, 26, and 31. Cisplatin is administered on weeks
17, 23, and 29. Pilot 3: (Open to accrual as of 6/2/2000) Patients receive preoperative
therapy comprised of methotrexate, dexrazoxane, doxorubicin, ifosfamide, and cisplatin as in
pilot 2. Patients undergo surgery on week 11, then begin adjuvant chemotherapy on week 13.
Group 1: Patients receive methotrexate, dexrazoxane, doxorubicin, ifosfamide, and cisplatin
as in pilot 2, group 1. Group 2: Patients receive methotrexate on weeks 13, 19, 29, 32, 35,
and 36, high dose ifosfamide and etoposide IV over 4 hours on days 1-5 of weeks 14, 23, and
26, and cisplatin on weeks 20, 30, and 33. Dexrazoxane and doxorubicin are administered on
weeks 17, 20, 30, and 33. Patients are followed every 3 months for 1 year, every 6 months
for 4 years and then annually thereafter.

PROJECTED ACCRUAL: Approximately 180 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven newly diagnosed moderate or high grade
osteosarcoma without metastases No prior treatment, including complete resection No
parosteal or periosteal sarcoma No osteosarcoma associated with Paget's disease No
nonresectable tumors or tumors that may result in marginal or interlesion resection Must
be enrolled on protocol POG-9851

PATIENT CHARACTERISTICS: Age: 30 and under Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times normal SGOT no greater
than 3 times normal Renal: Creatinine normal Phosphate at least 3.0 mg/dL without
supplementation Cardiovascular: Shortening fraction at least 28% by echocardiogram If
echocardiogram unsatisfactory, must have ejection fraction at least 50% No history of
pericarditis or myocarditis No symptomatic arrhythmia or symptomatic cardiac conduction
disturbances

PRIOR CONCURRENT THERAPY: See Disease Characteristics Biologic therapy: Not specified
Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No
prior radiotherapy Surgery: See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Cindy Schwartz, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000067129

NCT ID:

NCT00003937

Start Date:

September 1999

Completion Date:

Related Keywords:

  • Cardiac Toxicity
  • Sarcoma
  • localized osteosarcoma
  • cardiac toxicity
  • Osteosarcoma
  • Sarcoma

Name

Location

Baylor College of MedicineHouston, Texas  77030
Arizona Cancer CenterTucson, Arizona  85724
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
Emory University Hospital - AtlantaAtlanta, Georgia  30322
Rush-Presbyterian-St. Luke's Medical CenterChicago, Illinois  60612
University of Chicago Cancer Research CenterChicago, Illinois  60637
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Massachusetts Memorial Medical CenterWorcester, Massachusetts  01655
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
University of Mississippi Medical CenterJackson, Mississippi  39216-4505
Washington University School of MedicineSaint Louis, Missouri  63110
University of Rochester Cancer CenterRochester, New York  14642
State University of New York Health Sciences Center - Stony BrookStony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Ireland Cancer CenterCleveland, Ohio  44106-5065
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Simmons Cancer Center - DallasDallas, Texas  75235-9154
University of California Davis Medical CenterSacramento, California  95817
Shands Hospital and Clinics, University of FloridaGainesville, Florida  32610-100277
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
CCOP - Florida PediatricTampa, Florida  33682-7757
Tripler Army Medical CenterHonolulu, Hawaii  96859-5000
CCOP - WichitaWichita, Kansas  67214-3882
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
East Carolina University School of MedicineGreenville, North Carolina  27858-4354
Oklahoma Memorial HospitalOklahoma City, Oklahoma  73126-0307
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
Vermont Cancer CenterBurlington, Vermont  05401-3498
Midwest Children's Cancer CenterMilwaukee, Wisconsin  53226
University of California San Diego Cancer CenterLa Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Marlene & Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
State University of New York - Upstate Medical UniversitySyracuse, New York  13210
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Northern New JerseyHackensack, New Jersey  07601
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
CCOP - OchsnerNew Orleans, Louisiana  70121
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
CCOP - Merit Care HospitalFargo, North Dakota  58122
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Holden Comprehensive Cancer Center at The University of IowaIowa City, Iowa  52242-1009
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
Boston Floating Hospital Infants and ChildrenBoston, Massachusetts  02111
David Grant Medical CenterTravis Air Force Base, California  94535
Baptist Hospital of MiamiMiami, Florida  33176-2197
Tulane University School of MedicineNew Orleans, Louisiana  70112
CCOP - Columbia River ProgramPortland, Oregon  97213
University of Texas Medical BranchGalveston, Texas  77555-1329
Naval Medical Center, PortsmouthPortsmouth, Virginia  23708-2197
Massey Cancer CenterRichmond, Virginia  23298-0037
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Cancer Research Center of HawaiiHonolulu, Hawaii  96813
MBCCOP - Gulf CoastMobile, Alabama  36688
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
University of Kansas Medical CenterKansas City, Kansas  66160-7353
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Keesler Medical Center - Keesler AFBKeesler AFB, Mississippi  39534-2576
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
Madigan Army Medical CenterTacoma, Washington  98431-5048
Sutter Cancer CenterSacramento, California  95816
Eastern Maine Medical CenterBangor, Maine  04401
Veterans Affairs Medical Center - FargoFargo, North Dakota  58102
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Hackensack University Medical CenterHackensack, New Jersey  07601
Long Beach Memorial Medical CenterLong Beach, California  90806
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
Children's Hospital Medical Center - CincinnatiCincinnati, Ohio  45229-3039
Children's Hospital of ColumbusColumbus, Ohio  43205-2696
Doernbecher Children's HospitalPortland, Oregon  97201-3098
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - SeattleSeattle, Washington  98105
Kaiser Permanente Medical Center - Santa ClaraSanta Clara, California  95051-5386
Nemours Children's ClinicJacksonville, Florida  32207
Miami Children's HospitalMiami, Florida  33155-4069
All Children's HospitalSt. Petersburg, Florida  33701
St. Mary's HospitalWest Palm Beach, Florida  33407
Saint Jude Midwest AffiliatePeoria, Illinois  61637
Via Christi Regional Medical CenterWichita, Kansas  67214
Maine Children's Cancer ProgramScarborough, Maine  04074-9308
University of Missouri-Columbia Hospital and ClinicsColumbia, Missouri  65212
Cardinal Glennon Children's HospitalSaint Louis, Missouri  63104
Schneider Children's HospitalNew Hyde Park, New York  11042
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Legacy Emanuel Hospital and Health CenterPortland, Oregon  97227
St. Christopher's Hospital for ChildrenPhiladelphia, Pennsylvania  19134-1095
Children's Hospital of Greenville Hospital SystemGreenville, South Carolina  29605
Inova Fairfax HospitalFalls Church, Virginia  22042-3300
West Virginia University HospitalsMorgantown, West Virginia  26506-9300
Lucile Packard Children's Hospital at StanfordPalo Alto, California  94304
Hope Children's HospitalOak Lawn, Illinois  60453
Mission Saint Joseph's Health SystemAsheville, North Carolina  28801
Natalie Warren Bryant Cancer CenterTulsa, Oklahoma  74136
Saint Jude Children's Research HospitalMemphis, Tennessee  38105-2794
Children's Hospital and Health CenterSan Diego, California  92123-4282
Children's Memorial Hospital, ChicagoChicago, Illinois  60614
MBCCOP - South Texas PediatricSan Antonio, Texas  78284-7810
Kaiser Permanente-Southern California Permanente Medical GroupSan Diego, California  92120
Scott and White ClinicTemple, Texas  76508
James H. Quillen College of MedicineJohnson City, Tennessee  37614-0622
Carilion Roanoke Community HospitalRoanoke, Virginia  24013
Walt Disney Memorial Cancer InstituteOrlando, Florida  32803
University of New Mexico School of MedicineAlbuquerque, New Mexico  87131
St. John's Hospital and Medical CenterDetroit, Michigan  48236
West Virginia University Medical School-CharlestonCharleston, West Virginia  25304
Texas Oncology P.A.Dallas, Texas  75230-2503