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


Phase 2
N/A
21 Years
Open (Enrolling)
Both
Sarcoma

Thank you

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.

Inclusion 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)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Alberto S. Pappo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000064905

NCT ID:

NCT00002804

Start Date:

September 1996

Completion Date:

Related Keywords:

  • Sarcoma
  • nonmetastatic childhood soft tissue sarcoma
  • metastatic childhood soft tissue sarcoma
  • Sarcoma

Name

Location

Cancer Center, University of Virginia HSCCharlottesville, Virginia  22908
MBCCOP - LSU Medical CenterNew Orleans, Louisiana  70112
Medical City Dallas HospitalDallas, Texas  75230
San Antonio Military Pediatric Cancer and Blood Disorders CenterLackland Air Force Base, Texas  78236-5300
University of Texas Health Science Center at San AntonioSan Antonio, Texas  78284-7811
Via Christi Regional Medical CenterWichita, Kansas  67214
Saint Jude Children's Research HospitalMemphis, Tennessee  38105-2794