Combination Chemotherapy in Treating Patients With Stage III or Stage IV Malignant Peripheral Nerve Sheath Tumors

Plain-language summary

This study examines combination chemotherapy including doxorubicin, etoposide, and ifosfamide in patients with stage III or stage IV malignant peripheral nerve sheath tumors (MPNST). It enrolled newly diagnosed patients with measurable disease that was either sporadic or associated with neurofibromatosis type 1 (NF1). The research was conducted in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Sarcoma Alliance for Research through Collaboration

Intervention

filgrastim, doxorubicin hydrochloride, etoposide, ifosfamide, conventional surgery, radiation therapy

Start date

12/1/2005

Estimated completion

6/1/2014

Countries

United States

Related genes

Locations

• Birmingham, United States
• Santa Monica, United States
• Chicago, United States
• Indianapolis, United States
• Iowa City, United States
• Baltimore, United States
• Bethesda, United States
• Ann Arbor, United States
• Minneapolis, United States
• Charlotte, United States
• Cincinnati, United States
• Philadelphia, United States
• Philadelphia, United States
• Pittsburgh, United States
• Houston, United States
• Salt Lake City, United States
• Seattle, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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