Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Children With Advanced Soft Tissue Sarcoma
NCT ID: NCT00002804
Last Updated: 2014-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
1996-09-30
2006-04-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, surgery, and radiation therapy in treating children who have advanced soft tissue sarcoma.
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Detailed Description
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OUTLINE: The following acronyms are used: DOX Doxorubicin, NSC-123127 G-CSF Granulocyte Colony-Stimulating Factor (Amgen), NSC-614629 IFF Ifosfamide, NSC-109724 Mesna Mercaptoethane sulfonate, NSC-113891 VCR Vincristine, NSC-67574 VID VCR/IFF/DOX Induction: 3-Drug Combination Chemotherapy. VID. Local Control: Surgery and/or Radiotherapy plus 3-Drug Combination Chemotherapy. Excision of the primary tumor and pulmonary metastases; and/or irradiation of the primary tumor and pulmonary metastases using x-rays or Co60 beam energies of at least 4 MV (electrons or iridium-192 implant allowed for boost); plus VID. Continuation: 3-Drug Combination Chemotherapy. VID.
PROJECTED ACCRUAL: A total of 40 patients will be entered over 2.7 years if there are at least 7 responses in the first 20 patients.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chemotherapy Regimen
Induction (Weeks 1-6) Vincristine sulfate (1.5 mg/m2) day 1, Ifosfamide (3 grams/m2) days 1-3, Doxorubicin (30 mg/m2) days 1-2, filgrastim day 4. Weeks 2 and 3 - Vincristine sulfate (1.5 mg/m2) IV day 1, week 5 no chemotherapy. Evaluate for response. Local Control (Weeks 7-13) Conventional surgery and radiation therapy. Vincristine sulfate (1.5 mg/m2) IV day 1, Ifosfamide (3 grams/m2) days 1-3, Doxorubicin (30 mg/m2) days 1-2, filgrastim day 4. Treatment continues per protocol.
filgrastim
doxorubicin hydrochloride
ifosfamide
mesna
vincristine sulfate
conventional surgery
brachytherapy
low-LET cobalt-60 gamma ray therapy
low-LET electron therapy
low-LET photon therapy
Interventions
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filgrastim
doxorubicin hydrochloride
ifosfamide
mesna
vincristine sulfate
conventional surgery
brachytherapy
low-LET cobalt-60 gamma ray therapy
low-LET electron therapy
low-LET photon therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
PATIENT CHARACTERISTICS: Age: 21 and under Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine normal for age No hydronephrosis Cardiovascular: Shortening fraction greater than 28% Other: No HIV infection Not pregnant or nursing Effective contraception required of fertile women
PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy No prior nephrectomy (surgical correction of hydronephrosis allowed)
21 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Alberto S. Pappo, MD
Role: STUDY_CHAIR
St. Jude Children's Research Hospital
Locations
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Via Christi Regional Medical Center
Wichita, Kansas, United States
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States
Medical City Dallas Hospital
Dallas, Texas, United States
San Antonio Military Pediatric Cancer and Blood Disorders Center
Lackland Air Force Base, Texas, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, United States
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, , Puerto Rico
Clinique de Pediatrie
Geneva, , Switzerland
Countries
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Other Identifiers
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POG-9553
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000064905
Identifier Type: OTHER
Identifier Source: secondary_id
COG-P9953
Identifier Type: OTHER
Identifier Source: secondary_id
9553
Identifier Type: -
Identifier Source: org_study_id
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