Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Children With Advanced Soft Tissue Sarcoma
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, surgery, and radiation therapy in treating children who have advanced soft tissue sarcoma.
Drug: doxorubicin hydrochloride
Drug: vincristine sulfate
Procedure: conventional surgery
Radiation: low-LET cobalt-60 gamma ray therapy
Radiation: low-LET electron therapy
Radiation: low-LET photon therapy
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Neoadjuvant Vincristine, Ifosfamide, Doxorubicin, and AND G-CSF in Children With Advanced Stage Non-Rhabdomyosarcoma Soft Tissue Sarcomas|
- Estimate the response rate to the combination of vincristine, ifosfamide, and doxorubicin (VID), with G-CSF support [ Designated as safety issue: No ]To estimate the response rate to the combination of vincristine, ifosfamide, and doxorubicin (VID), with G-CSF support, in children with newly diagnosed inoperable or metastatic non-rhabdomyosarcoma soft tissue sarcomas.
- Event-free Survival [ Designated as safety issue: No ]To estimate the 2-year survival and event-free survival of children treated with VID in combination with radiotherapy and/or surgery
- Establish a bank of frozen tissue (tumor and peripheral blood) [ Designated as safety issue: No ]To establish a bank of frozen tissue (tumor and peripheral blood) for use in further molecular studies.
|Study Start Date:||September 1996|
|Study Completion Date:||April 2006|
|Primary Completion Date:||June 2000 (Final data collection date for primary outcome measure)|
Experimental: 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.
Other Names:Drug: doxorubicin hydrochloride
Other Names:Drug: ifosfamide
Other Names:Drug: mesna
Other Names:Drug: vincristine sulfate
Other Names:Procedure: conventional surgery Radiation: brachytherapy Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET electron therapy Radiation: low-LET photon therapy
OBJECTIVES: I. Assess the response to vincristine/ifosfamide/doxorubicin (VID) with granulocyte colony-stimulating factor support in children with newly diagnosed, inoperable or metastatic non-rhabdomyosarcoma soft tissue sarcomas. II. Estimate the 2-year and event-free survival rates in children treated with VID plus radiotherapy and/or surgery. III. Establish a bank of frozen tumor and peripheral blood tissue for use in further molecular studies.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002804
|United States, Kansas|
|Via Christi Regional Medical Center|
|Wichita, Kansas, United States, 67214|
|United States, Louisiana|
|MBCCOP - LSU Medical Center|
|New Orleans, Louisiana, United States, 70112|
|United States, Tennessee|
|Saint Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105-2794|
|United States, Texas|
|Medical City Dallas Hospital|
|Dallas, Texas, United States, 75230|
|San Antonio Military Pediatric Cancer and Blood Disorders Center|
|Lackland Air Force Base, Texas, United States, 78236-5300|
|University of Texas Health Science Center at San Antonio|
|San Antonio, Texas, United States, 78284-7811|
|United States, Virginia|
|Cancer Center, University of Virginia HSC|
|Charlottesville, Virginia, United States, 22908|
|University of Puerto Rico School of Medicine Medical Sciences Campus|
|San Juan, Puerto Rico, 00936-5067|
|Clinique de Pediatrie|
|Geneva, Switzerland, 1211|
|Study Chair:||Alberto S. Pappo, MD||St. Jude Children's Research Hospital|