Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Children With Advanced Soft Tissue Sarcoma
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|ClinicalTrials.gov Identifier: NCT00002804|
Recruitment Status : Completed
First Posted : July 1, 2004
Last Update Posted : July 25, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Sarcoma||Biological: filgrastim Drug: doxorubicin hydrochloride Drug: ifosfamide Drug: mesna Drug: vincristine sulfate Procedure: conventional surgery Radiation: brachytherapy Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET electron therapy Radiation: low-LET photon therapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Neoadjuvant Vincristine, Ifosfamide, Doxorubicin, and AND G-CSF in Children With Advanced Stage Non-Rhabdomyosarcoma Soft Tissue Sarcomas|
|Study Start Date :||September 1996|
|Actual Primary Completion Date :||June 2000|
|Actual Study Completion Date :||April 2006|
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.
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
- Estimate the response rate to the combination of vincristine, ifosfamide, and doxorubicin (VID), with G-CSF supportTo 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 SurvivalTo 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)To establish a bank of frozen tissue (tumor and peripheral blood) for use in further molecular studies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|