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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00002804
First received: November 1, 1999
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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 Intervention 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

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 43
Study Start Date: September 1996
Study Completion Date: April 2006
Primary Completion Date: June 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Biological: filgrastim
Other Names:
  • Granulocyte-Colony Stimulating Factor
  • Neupogen
  • G-CSF
Drug: doxorubicin hydrochloride
Other Names:
  • Adriamycin
  • NSC#123127
Drug: ifosfamide
Other Names:
  • Isophosphamide
  • IFEX
Drug: mesna
Other Names:
  • Sodium 2-Mercaptoethane Sulfonate
  • Mesnex
  • Urimetexan
  • NSC#113891
Drug: vincristine sulfate
Other Names:
  • VCR
  • Oncovin
  • NSC#67574
Procedure: conventional surgery Radiation: brachytherapy Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET electron therapy Radiation: low-LET photon therapy

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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)

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002804

Locations
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
Puerto Rico
University of Puerto Rico School of Medicine Medical Sciences Campus
San Juan, Puerto Rico, 00936-5067
Switzerland
Clinique de Pediatrie
Geneva, Switzerland, 1211
Sponsors and Collaborators
Children's Oncology Group
Investigators
Study Chair: Alberto S. Pappo, MD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00002804     History of Changes
Other Study ID Numbers: 9553, POG-9553, CDR0000064905, COG-P9953
Study First Received: November 1, 1999
Last Updated: July 24, 2014
Health Authority: United States: Federal Government

Keywords provided by Children's Oncology Group:
nonmetastatic childhood soft tissue sarcoma
metastatic childhood soft tissue sarcoma

Additional relevant MeSH terms:
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Mesna
Doxorubicin
Liposomal doxorubicin
Isophosphamide mustard
Ifosfamide
Vincristine
Lenograstim
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on August 18, 2014