Status:
COMPLETED
Combination Chemotherapy in Treating Patients With Stage III or Stage IV Malignant Peripheral Nerve Sheath Tumors
Lead Sponsor:
Sarcoma Alliance for Research through Collaboration
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Neurofibromatosis Type 1
Sarcoma
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, ifosfamide, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from di...
Detailed Description
OBJECTIVES: Primary * Determine the clinical response rate (complete and partial) in patients with sporadic or neurofibromatosis type 1 (NF1)-associated high-grade stage III or IV malignant peripher...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00304083
Start Date
December 1 2005
End Date
June 1 2014
Last Update
September 18 2018
Active Locations (17)
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1
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
2
Sarcoma Oncology Center
Santa Monica, California, United States, 90403
3
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60614
4
Indiana University
Indianapolis, Indiana, United States, 46202-5289