Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      OBJECTIVES: I. Determine the feasibility of sequential high-dose chemotherapy with ifosfamide
      and doxorubicin followed by melphalan and cisplatin, each followed by autologous peripheral
      blood stem cell support, in patients with high-risk or advanced sarcomas. II. Determine the
      toxic effects of this regimen in these patients. III. Determine response rate and
      disease-free and overall survival in these patients treated with this regimen.

      OUTLINE: Beginning at least 4 weeks prior to the start of chemotherapy, patients receive
      filgrastim (G-CSF) subcutaneously daily until the completion of peripheral blood stem cell
      (PBSC) harvesting. Beginning 5 days after the start of G-CSF, PBSCs are collected over
      several days. Patients who do not mobilize sufficient cells undergo bone marrow harvest.
      Regimen A: Patients receive high-dose ifosfamide IV and doxorubicin IV continuously over 96
      hours on days -8 to -4. 12.5% of PBSCs or bone marrow are reinfused on day -2 and 37.5% are
      reinfused on day 0. Patients receive G-CSF IV beginning on day 0 and continuing until blood
      counts recover. Regimen B: Beginning at least 4 weeks after day 1 of Regimen A, patients
      receive high-dose melphalan IV followed immediately by cisplatin IV on days -11 and -4.
      Patients receive G-CSF IV on days -10 to -6. 12.5% of PBSCs or bone marrow are reinfused on
      day -3 and the remaining 37.5% are reinfused on day 0. Patients receive G-CSF IV beginning on
      day 0 and continuing until blood counts recover. Patients are followed monthly for 1 year,
      every 3 months for 1 year, and then as needed for 3 years.

      PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 3 years.
    

Intervention name(s): filgrastim; cisplatin; doxorubicin hydrochloride; ifosfamide; melphalan; peripheral blood stem cell transplantation
Intervention type(s): Biological; Drug; Drug; Drug; Drug; Procedure
Intervention description(s): 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
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
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