Yükleniyor... / Loading...
Combination Chemotherapy in Treating Patients With Stage III or Stage IV Malignant Peripheral Nerve Sheath Tumors
Bu çalışma, evre III veya evre IV kötü huylu periferik sinir kılıfı tümörü (malignant peripheral nerve sheath tumor, MPNST) olan hastalarda doxorubicin, etoposide ve ifosfamide içeren kombinasyon kemoterapisini incelemektedir. Çalışmaya, sporadik ya da nörofibromatozis tip 1 (NF1) ile ilişkili, yeni tanı almış ve ölçülebilir hastalığı olan hastalar alınmıştır. Araştırma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
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