PHASE II STUDY OF NEOADJUVANT VINCRISTINE, IFOSFAMIDE, DOXORUBICIN, AND G-CSF IN CHILDREN WITH ADVANCED STAGE NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMAS

Trial Information

PHASE II STUDY OF NEOADJUVANT VINCRISTINE, IFOSFAMIDE, DOXORUBICIN, AND G-CSF IN CHILDREN WITH ADVANCED STAGE NON-RHABDOMYOSARCOMA SOFT TISSUE SARCOMAS

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.