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A Randomized Study of the Effect of Adjuvant Chemotherapy With Doxorubicin and Ifosfamide With Mesna in the Treatment of High-Grade Adult Extremity Soft Tissue Sarcoma

Phase 3
Not Enrolling

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Trial Information

A Randomized Study of the Effect of Adjuvant Chemotherapy With Doxorubicin and Ifosfamide With Mesna in the Treatment of High-Grade Adult Extremity Soft Tissue Sarcoma

Patients with primary, high-grade soft tissue sarcoma of the extremities will undergo
treatment of their primary tumor with either amputation or limb-sparing surgery and
radiotherapy, and then be randomized to either observation or adjuvant treatment with
doxorubicin and ifosfamide with mesna (with G-CSF) for five cycles beginning
post-operatively. Local recurrence, disease-free survival and overall survival will be
evaluated in this randomized two-arm trial.

Inclusion Criteria


Histologically proven AR and ESFT which includes: Classical, atypical and extraosseous
Ewing's sarcoma, primitive peripheral neuroectodermal tumors, peripheral neuroepithelioma,
primitive sarcoma of bone, and ectomesenchymoma.

Confirmed presence of tumor-specific infusion protein by documented RT-PCR which
corresponds to one of the tumor specific peptides available for vaccination.

Measurable tumor.

No prior or current CNS metastases.


Arm A patients:

May be enrolled on the protocol for the first phase in the absence of RT PCR documentation
of a tumor-specific fusion protein which corresponds to one of the tumor-specific peptides
available for vaccination. However, RT PCR documentation at the time of tumor recurrence
must occur prior to administration of immunotherapy. At time of initial tumor diagnosis,
prior to any cytoreductive therapy.

Arm B patients:

Tumor recurrence occurring during or after receiving at least first line cytoreductive
therapy for ESFT and AR. No more than two post-recurrence salvage regimens unless
peripheral CD4+T cell number is greater than 400 cells per millimeter cubed.

At least 6 weeks since any treatments and recovered from all acute toxic effects from time
in which immunotherapy will be started for this study.

No concurrent estrogen therapy during immunotherapy section of study.


Age: 2-25 (at time of initial diagnosis of alveolar rhabdomyosarcoma).

Weight: Greater than 15 kg (at time of apheresis).

Performance status: ECOG 0-2.

Life expectancy: At least 8 weeks.


ANC greater than 100,000/mm3.

Hemoglobin greater than 9.0 g/dL.

Platelet count greater than 50,000/mm3.


Bilirubin less than 2.0 mg/dL (unless related to involvement by tumor).

Transaminases less than 3 times normal (unless related to involvement by tumor).


Creatinine less than 1.5 mg/dL or creatinine clearance greater than 60 mL/min.


No major disorder of cardiovascular system.

Cardiac ejection fraction greater than 40%.


No major disorder of pulmonary system.


Not pregnant or nursing.

HIV negative.

Hepatitis B or C negative.

No patients requiring daily oral corticosteroid therapy.

If allergic to eggs, egg products, or thimerosal, or have a history of Guillain-Barre
syndrome, ineligible to receive influenza vaccine.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Primary Purpose: Treatment


United States: Federal Government

Study ID:




Start Date:

June 1992

Completion Date:

March 2001

Related Keywords:

  • Sarcoma
  • Adjuvant Chemotherapy
  • Ifosfamide
  • Randomized Study
  • Soft Tissue Sarcoma
  • Sarcoma



National Cancer Institute (NCI) Bethesda, Maryland  20892