Know Cancer

or
forgot password

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 Medicine Houston, Texas  77030
Arizona Cancer Center Tucson, Arizona  85724
Roswell Park Cancer Institute Buffalo, New York  14263
Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Children's Hospital of Philadelphia Philadelphia, Pennsylvania  19104
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Walter Reed Army Medical Center Washington, District of Columbia  20307-5000
Emory University Hospital - Atlanta Atlanta, Georgia  30322
Rush-Presbyterian-St. Luke's Medical Center Chicago, Illinois  60612
University of Chicago Cancer Research Center Chicago, Illinois  60637
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Massachusetts Memorial Medical Center Worcester, Massachusetts  01655
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
University of Mississippi Medical Center Jackson, Mississippi  39216-4505
Washington University School of Medicine Saint Louis, Missouri  63110
University of Rochester Cancer Center Rochester, New York  14642
State University of New York Health Sciences Center - Stony Brook Stony Brook, New York  11790-7775
Lineberger Comprehensive Cancer Center, UNC Chapel Hill, North Carolina  27599-7295
Duke Comprehensive Cancer Center Durham, North Carolina  27710
Ireland Cancer Center Cleveland, Ohio  44106-5065
Medical University of South Carolina Charleston, South Carolina  29425-0721
Simmons Cancer Center - Dallas Dallas, Texas  75235-9154
University of California Davis Medical Center Sacramento, California  95817
Shands Hospital and Clinics, University of Florida Gainesville, Florida  32610-100277
Sylvester Cancer Center, University of Miami Miami, Florida  33136
CCOP - Florida Pediatric Tampa, Florida  33682-7757
Tripler Army Medical Center Honolulu, Hawaii  96859-5000
CCOP - Wichita Wichita, Kansas  67214-3882
Children's Hospital of Michigan Detroit, Michigan  48201
Hurley Medical Center Flint, Michigan  48503
Mount Sinai School of Medicine New York, New York  10029
Presbyterian Healthcare Charlotte, North Carolina  28233-3549
East Carolina University School of Medicine Greenville, North Carolina  27858-4354
Oklahoma Memorial Hospital Oklahoma City, Oklahoma  73126-0307
Medical City Dallas Hospital Dallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders Center Lackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San Antonio San Antonio, Texas  78284-7811
Vermont Cancer Center Burlington, Vermont  05401-3498
Midwest Children's Cancer Center Milwaukee, Wisconsin  53226
University of California San Diego Cancer Center La Jolla, California  92093-0658
UCSF Cancer Center and Cancer Research Institute San Francisco, California  94115-0128
Marlene & Stewart Greenebaum Cancer Center, University of Maryland Baltimore, Maryland  21201
Norris Cotton Cancer Center Lebanon, New Hampshire  03756
State University of New York - Upstate Medical University Syracuse, New York  13210
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Northern New Jersey Hackensack, New Jersey  07601
Yale Comprehensive Cancer Center New Haven, Connecticut  06520-8028
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
CCOP - Ochsner New Orleans, Louisiana  70121
Massachusetts General Hospital Cancer Center Boston, Massachusetts  02114
CCOP - Merit Care Hospital Fargo, North Dakota  58122
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
Holden Comprehensive Cancer Center at The University of Iowa Iowa City, Iowa  52242-1009
Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Cancer Center at the University of Virginia Charlottesville, Virginia  22908
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
Boston Floating Hospital Infants and Children Boston, Massachusetts  02111
David Grant Medical Center Travis Air Force Base, California  94535
Baptist Hospital of Miami Miami, Florida  33176-2197
Tulane University School of Medicine New Orleans, Louisiana  70112
CCOP - Columbia River Program Portland, Oregon  97213
University of Texas Medical Branch Galveston, Texas  77555-1329
Naval Medical Center, Portsmouth Portsmouth, Virginia  23708-2197
Massey Cancer Center Richmond, Virginia  23298-0037
St. Vincent Hospital Green Bay, Wisconsin  54307-3508
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Cancer Research Center of Hawaii Honolulu, Hawaii  96813
MBCCOP - Gulf Coast Mobile, Alabama  36688
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
University of Kansas Medical Center Kansas City, Kansas  66160-7353
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
Keesler Medical Center - Keesler AFB Keesler AFB, Mississippi  39534-2576
Herbert Irving Comprehensive Cancer Center New York, New York  10032
Madigan Army Medical Center Tacoma, Washington  98431-5048
Sutter Cancer Center Sacramento, California  95816
Eastern Maine Medical Center Bangor, Maine  04401
Veterans Affairs Medical Center - Fargo Fargo, North Dakota  58102
Cancer Institute of New Jersey New Brunswick, New Jersey  08901
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
Hackensack University Medical Center Hackensack, New Jersey  07601
Long Beach Memorial Medical Center Long Beach, California  90806
Children's Hospital Los Angeles Los Angeles, California  90027-0700
Children's Hospital of Orange County Orange, California  92668
Children's Hospital of Denver Denver, Colorado  80218
Children's National Medical Center Washington, District of Columbia  20010-2970
Children's Mercy Hospital Kansas City, Missouri  64108
Children's Hospital Medical Center - Cincinnati Cincinnati, Ohio  45229-3039
Children's Hospital of Columbus Columbus, Ohio  43205-2696
Doernbecher Children's Hospital Portland, Oregon  97201-3098
Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania  15213
Children's Hospital and Regional Medical Center - Seattle Seattle, Washington  98105
Kaiser Permanente Medical Center - Santa Clara Santa Clara, California  95051-5386
Nemours Children's Clinic Jacksonville, Florida  32207
Miami Children's Hospital Miami, Florida  33155-4069
All Children's Hospital St. Petersburg, Florida  33701
St. Mary's Hospital West Palm Beach, Florida  33407
Saint Jude Midwest Affiliate Peoria, Illinois  61637
Via Christi Regional Medical Center Wichita, Kansas  67214
Maine Children's Cancer Program Scarborough, Maine  04074-9308
University of Missouri-Columbia Hospital and Clinics Columbia, Missouri  65212
Cardinal Glennon Children's Hospital Saint Louis, Missouri  63104
Schneider Children's Hospital New Hyde Park, New York  11042
Carolinas Medical Center Charlotte, North Carolina  28232-2861
Legacy Emanuel Hospital and Health Center Portland, Oregon  97227
St. Christopher's Hospital for Children Philadelphia, Pennsylvania  19134-1095
Children's Hospital of Greenville Hospital System Greenville, South Carolina  29605
Inova Fairfax Hospital Falls Church, Virginia  22042-3300
West Virginia University Hospitals Morgantown, West Virginia  26506-9300
Lucile Packard Children's Hospital at Stanford Palo Alto, California  94304
Hope Children's Hospital Oak Lawn, Illinois  60453
Mission Saint Joseph's Health System Asheville, North Carolina  28801
Natalie Warren Bryant Cancer Center Tulsa, Oklahoma  74136
Saint Jude Children's Research Hospital Memphis, Tennessee  38105-2794
Children's Hospital and Health Center San Diego, California  92123-4282
Children's Memorial Hospital, Chicago Chicago, Illinois  60614
MBCCOP - South Texas Pediatric San Antonio, Texas  78284-7810
Kaiser Permanente-Southern California Permanente Medical Group San Diego, California  92120
Scott and White Clinic Temple, Texas  76508
James H. Quillen College of Medicine Johnson City, Tennessee  37614-0622
Carilion Roanoke Community Hospital Roanoke, Virginia  24013
Walt Disney Memorial Cancer Institute Orlando, Florida  32803
University of New Mexico School of Medicine Albuquerque, New Mexico  87131
St. John's Hospital and Medical Center Detroit, Michigan  48236
West Virginia University Medical School-Charleston Charleston, West Virginia  25304
Texas Oncology P.A. Dallas, Texas  75230-2503