Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma
Intervention: filgrastim; cisplatin; doxorubicin hydrochloride; ifosfamide; melphalan; peripheral blood stem cell transplantation
Intervention description: 5 ug/kg daily following stem cell reinfusion; Course 2 - 100 mg/m2 at an infusion rate of 25 mg/hr; Course 1 - 150 mg/m2 by continuous intravenous infusion for 96 hours.; Course 1 - 14 gm/M2 by continuous intravenous infusion for 96 hours.; Course 2 - 75 mg/m2 infused at a rate of 5 mg/minute; Administered on Day 0 following high-dose chemotherapy in both courses 1 and 2
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin; Melphalan; Ifosfamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 10 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: metastatic osteosarcoma; recurrent childhood rhabdomyosarcoma; recurrent adult soft tissue sarcoma; recurrent osteosarcoma; adult rhabdomyosarcoma; metastatic childhood soft tissue sarcoma; recurrent childhood soft tissue sarcoma; previously treated childhood rhabdomyosarcoma; metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor; recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor; stage IV adult soft tissue sarcoma

Summary:

      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug and combining chemotherapy with
      peripheral stem cell transplantation may allow the doctor to give higher doses of
      chemotherapy drugs and kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of high-dose combination chemotherapy and
      peripheral stem cell transplantation in treating patients who have advanced or recurrent
      sarcoma.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS: Histologically confirmed sarcomas in the following categories:
        Soft tissue sarcoma (STS) High-grade STS of the extremities Primary extending to fascia or
        locally recurrent At least 10 cm in greatest dimension or multifocal on surgical pathology
        Primary site controlled by surgery and/or radiotherapy High-grade truncal or head and neck
        sarcoma At least 10 cm in greatest dimension or any size with no surgical options for clear
        margins Primary site controlled by surgery and/or radiotherapy Locally recurrent disease in
        CR or PR after surgery, chemotherapy, or radiotherapy Metastatic STS in CR or PR after
        surgery, chemotherapy, or radiotherapy Osteosarcoma (OS) Extremity OS after neoadjuvant
        chemotherapy and surgical resection provided: Less than 50% necrosis in the surgical
        specimen LDH or alkaline phosphatase greater than 2 times normal at presentation Axial OS
        in CR or PR after chemotherapy and/or surgery Primary or recurrent metastatic OS in CR or
        PR after chemotherapy, surgery, and/or radiotherapy Ewing's sarcoma or primitive
        neuroectodermal tumor Primary site in CR or PR after chemotherapy, radiotherapy, or surgery
        Rib, pelvic, or axial skeleton primary Bulky tumor (at least 10 cm in greatest diameter)
        Primary or recurrent metastatic disease in CR or PR after surgery, chemotherapy, or
        radiotherapy Rhabdomyosarcoma Gross residual disease after primary treatment with surgery,
        chemotherapy, and radiotherapy Primary group IV or recurrent metastatic disease in CR or PR
        after chemotherapy and radiotherapy with or without surgery No brain metastasis No
        histologically confirmed bone marrow metastasis Prior metastases allowed with clearing of
        bone marrow at entry No contraindication to collection of mobilized stem cells or, if
        needed, autologous bone marrow

        PATIENT CHARACTERISTICS: Age: 10 to 55 Performance status: Karnofsky 80-100% Hematopoietic:
        Absolute neutrophil count greater than 2,000/mm3 Platelet count greater than 150,000/mm3
        Hemoglobin greater than 10 g/dL Hepatic: See Disease Characteristics Bilirubin less than
        1.5 mg/dL AST and ALT less than 3 times normal Hepatitis B surface antigen negative
        Negative hepatitis C antigen test required in patients with hepatitis C antibody Renal:
        Creatinine less than 1.4 mg/dL Creatinine clearance greater than 75 mL/min Cardiovascular:
        LVEF at least 55% by MUGA or echocardiogram No history of significant cardiac disease
        Pulmonary: FEV1 greater than 2 liters PaO2 greater than 70 mm Hg on room air PaCO2 less
        than 42 mm Hg on room air DLCO greater than 60% predicted Other: No hearing loss of greater
        than 40 decibels HIV negative No organic or psychiatric CNS dysfunction that would preclude
        study No other medical or psychosocial problems that would place patient at unacceptable
        risk No history of other malignancy except nonmelanoma skin cancer or carcinoma in situ of
        the cervix Not pregnant Negative pregnancy test Fertile patients must use effective
        contraception

        PRIOR CONCURRENT THERAPY: More than 2 weeks since treatment to control primary or recurrent
        tumor Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No more
        than 2 prior chemotherapy regimens (including adjuvant therapy) Prior cumulative cisplatin
        dose less than 400 mg/m2 Prior cumulative doxorubicin dose less than 240 mg/m2 Endocrine
        therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to
        more than 20% of the bone marrow-containing axial skeleton No prior radiotherapy to the
        left chest wall Surgery: See Disease Characteristics