Combination Chemotherapy and Dexrazoxane Followed by Surgery and Radiation Therapy in Treating Patients With Advanced Soft Tissue Sarcoma or Recurrent Bone Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma; Osteosarcoma
Intervention: filgrastim; dexrazoxane hydrochloride; doxorubicin hydrochloride; ifosfamide; irinotecan hydrochloride; protein expression analysis; immunoenzyme technique; adjuvant therapy; conventional surgery; neoadjuvant therapy; radiation therapy
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Dexrazoxane; Irinotecan; Ifosfamide; Razoxane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: recurrent adult soft tissue sarcoma; stage III adult soft tissue sarcoma; stage IV adult soft tissue sarcoma; metastatic osteosarcoma; recurrent osteosarcoma; metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor; recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor; Ewing sarcoma of bone

Summary:

      RATIONALE: Drugs used in chemotherapy, such as doxorubicin, ifosfamide, and irinotecan, work
      in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. Chemoprotective drugs, such as dexrazoxane, may protect normal
      cells from the side effects of chemotherapy. Giving combination chemotherapy together with
      dexrazoxane before surgery may make the tumor smaller and reduce the amount of normal tissue
      that needs to be removed. Giving radiation therapy after surgery may kill any tumor cells
      that remain after surgery.

      PURPOSE: This phase II trial is studying how well giving combination chemotherapy together
      with dexrazoxane followed by surgery and radiation therapy works in treating patients with
      advanced soft tissue sarcoma or recurrent bone sarcoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of 1 of the following:

               -  Primary soft tissue sarcoma at high-risk* for recurrence, meeting any of the
                  following criteria:

                    -  Previously untreated locally advanced, nonmetastatic disease

                    -  Advanced (metastatic) disease not amenable to standard or higher priority
                       investigational neoadjuvant therapies

               -  Recurrent bone sarcoma (e.g., osteogenic sarcoma, Ewing sarcoma, or peripheral
                  neuroectodermal tumor)

                    -  Must have advanced locally recurrent or metastatic disease NOTE: *High-risk
                       is defined as high-grade, deep to fascia, and > 5 cm in greatest dimension

          -  Measurable or nonmeasurable disease is not required

          -  Pre-chemotherapy consultation with surgery and radiation oncology is required for
             formulation of loco-regional therapy

          -  No gastrointestinal stromal cell sarcoma

          -  No alveolar soft part sarcoma

          -  No symptomatic brain metastases

               -  No requirement for anticonvulsant or corticosteroid therapy

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 70-100%

          -  Life expectancy ≥ 2 months

          -  Absolute neutrophil count ≥ 2,000/mm^3

          -  Platelet count > 120,000/mm^3

          -  Creatinine clearance > 50 mL/min

          -  Serum bilirubin ≤ 1.5 mg/dL

          -  SGOT or SGPT ≤ 2.5 times upper limit of normal

          -  Serum albumin ≥ 2.5 mg/dL

          -  LVEF ≥ 50% by MUGA scan

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  No concurrent nonmalignant illness (e.g., cardiovascular, pulmonary, or CNS disease)
             that is poorly controlled with currently available treatment or is of such severity
             that the investigators deem it unwise for the patient to enter the study

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior chemotherapy for recurrent (local or metastatic) soft tissue sarcoma

          -  Prior chemotherapy for recurrent bone sarcoma allowed provided the total dose of
             doxorubicin hydrochloride is ≤ 300 mg/m^2

          -  No prior radiotherapy to > 25% of bone marrow

          -  At least 3 weeks since prior radiotherapy or chemotherapy