Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Children With Advanced Soft Tissue Sarcoma

Sarcoma Clinical Trial

Official title:

Phase II Study of Neoadjuvant Vincristine, Ifosfamide, Doxorubicin, and AND G-CSF in Children With Advanced Stage Non-Rhabdomyosarcoma Soft Tissue Sarcomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002804
• Other study ID #: 9553
• Secondary ID: POG-9553CDR00000
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: July 24, 2014
• Start date: September 1996
• Est. completion date: April 2006

Study information

• Verified date: July 2014
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 2006
• Est. primary completion date: June 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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

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)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcoma

Intervention

Biological:
• filgrastim

Drug:
• doxorubicin hydrochloride

• ifosfamide

• mesna

• vincristine sulfate

Procedure:
• conventional surgery

Radiation:
• brachytherapy

• low-LET cobalt-60 gamma ray therapy

• low-LET electron therapy

• low-LET photon therapy

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico School of Medicine Medical Sciences Campus	San Juan
Switzerland	Clinique de Pediatrie	Geneva
United States	Cancer Center, University of Virginia HSC	Charlottesville	Virginia
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	Saint Jude Children's Research Hospital	Memphis	Tennessee
United States	MBCCOP - LSU Medical Center	New Orleans	Louisiana
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Via Christi Regional Medical Center	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Puerto Rico,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimate the response rate to the combination of vincristine, ifosfamide, and doxorubicin (VID), with G-CSF support	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.		No
Secondary	Event-free Survival	To estimate the 2-year survival and event-free survival of children treated with VID in combination with radiotherapy and/or surgery		No
Secondary	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.		No