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	Treatment or Intervention	Phase
nonmetastatic childhood soft tissue sarcoma metastatic childhood soft tissue sarcoma	Drug: doxorubicin  Drug: filgrastim  Drug: ifosfamide  Drug: mesna  Drug: vincristine	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  up to  21 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Biopsy proven non-rhabdomyosarcoma soft tissue sarcoma (NRSTS); Evaluable residual tumor after initial biopsy or excision required; Registration required within 42 days of definitive diagnosis
• Grade II/III, unresectable or metastatic disease
• The following histologies exclude: Angiofibroma of the nasopharynx; Mesothelioma; Desmoid tumor; Peripheral neuroepithelioma; Desmoplastic small cell tumor; Rhabdomyosarcoma; Extraosseous Ewing's sarcoma; Undifferentiated sarcoma; Kaposi's sarcoma; Grade 1 NRSTS, including: Angiomatoid malignant fibrous histiocytoma; Dermatofibrosarcoma protuberans; Myxoid and well-differentiated liposarcoma; Well-differentiated and infantile hemangiopericytoma; Well-differentiated malignant peripheral nerve sheath tumor

--Prior/Concurrent Therapy--

• No prior chemotherapy or radiotherapy; No prior nephrectomy (surgical correction of hydronephrosis allowed)

--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

Kansas
      Via Christi Regional Medical Center, Wichita,  Kansas,  67214,  United States
Louisiana
      MBCCOP - LSU Medical Center, New Orleans,  Louisiana,  70112,  United States
Tennessee
      Saint Jude Children's Research Hospital, Memphis,  Tennessee,  38105-2794,  United States
Texas
      Medical City Dallas Hospital, Dallas,  Texas,  75230,  United States
      San Antonio Military Pediatric Cancer and Blood Disorders Center, Lackland Air Force Base,  Texas,  78236-5300,  United States
      University of Texas Health Science Center at San Antonio, San Antonio,  Texas,  78284-7811,  United States
Virginia
      Cancer Center, University of Virginia HSC, Charlottesville,  Virginia,  22908,  United States
Puerto Rico
      University of Puerto Rico School of Medicine Medical Sciences Campus, San Juan,  00936-5067,  Puerto Rico
Switzerland
      Clinique de Pediatrie, Geneva,  1211,  Switzerland

Study chairs or principal investigators

Alberto Pappo,  Study Chair,  Pediatric Oncology Group   

Study ID Numbers:  CDR0000064905; POG-9553
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002804
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08