Combination Chemotherapy in Treating Patients With Stage III or Stage IV Malignant Peripheral Nerve Sheath Tumors
Neurofibromatosis Type 1, Sarcoma
About this trial
This is an interventional treatment trial for Neurofibromatosis Type 1 focused on measuring adult neurofibrosarcoma, childhood neurofibrosarcoma, metastatic childhood soft tissue sarcoma, nonmetastatic childhood soft tissue sarcoma, stage IV adult soft tissue sarcoma, neurofibromatosis type 1
Eligibility Criteria
DISEASE CHARACTERISTICS: Newly diagnosed sporadic or neurofibromatosis type 1 (NF1)-associated high-grade malignant peripheral nerve sheath tumors (MPNSTs) Stage III or stage IV (metastatic) disease Measurable disease, defined as at least 1 tumor that is measurable in 2 dimensions on CT scan or MRI PATIENT CHARACTERISTICS: Ejection fraction normal by echocardiogram or MUGA Serum creatinine normal for age OR creatinine clearance > 60 mL/min SGPT < 5 times upper limit of normal (ULN) Bilirubin < 2.5 times ULN Absolute neutrophil count ≥ 1,500/mm^3* Hemoglobin ≥ 9.0 g/dL* Platelet count ≥ 100,000/mm^3* ECOG performance status 0-2 Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after completion of study treatment NOTE: * Unsupported PRIOR CONCURRENT THERAPY: No prior chemotherapy for MPNST Prior surgical resection of MPNST allowed provided residual or recurrent measurable disease is present Recovered from toxic effects of all prior therapy At least 3 weeks since prior chemotherapy or biologic therapy for treatment of a plexiform neurofibroma, optical pathway tumor, or other NF1-associated tumor (in patients with NF1) At least 6 weeks since prior radiotherapy for treatment of a plexiform neurofibroma, optical pathway tumor, or other NF1-associated tumor (in patients with NF1) At least 4 weeks since prior radiotherapy to the area involved by MPNST No other concurrent growth factors (e.g., sargramostim [GM-CSF] or interleukin-11) Concurrent epoetin alfa allowed
Sites / Locations
- UAB Comprehensive Cancer Center
- Sarcoma Oncology Center
- Children's Memorial Hospital - Chicago
- Indiana University
- University of Iowa Hospitals and Clinics
- Johns Hopkins
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
- University of Michigan Comprehensive Cancer Center
- University of Minnesota
- Carolinas Hematology-Oncology Associates
- Cincinnati Children's Hospital Medical Center
- Children's Hospital of Philadelphia
- Pennsylvania Oncology Hematology Associates
- Children's Hospital of Pittsburgh
- M. D. Anderson Cancer Center at University of Texas
- Huntsman Cancer Institute at University of Utah
- Seattle Cancer Care Alliance at Washington University
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Chemotherapy and local control by radiotherapy and surgery
Chemotherapy and local control by surgery
Patients receive doxorubicin hydrochloride and ifosfamide (IA) chemotherapy. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity. Patients then receive etoposide and ifosfamide (IE) chemotherapy. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients also receive filgrastim (G-CSF) subcutaneously (SC) after each chemotherapy course. After recovery from chemotherapy, patients undergo radiotherapy and receive 2 more courses of IE during radiotherapy followed by 2 more courses of IA after completion of radiotherapy. Some patients may then undergo surgery.
Patients receive 2 courses of IA followed by 2 courses of IE as above. After recovery from chemotherapy, patients undergo surgery. After recovery from surgery, patients receive 2 more courses of IA followed by 2 more courses of IE in the absence of disease progression or unacceptable toxicity.