PEG-Interferon Alfa-2b in Treating Young Patients With Plexiform Neurofibroma

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Diagnosis of plexiform neurofibroma which is progressive, symptomatic, or life threatening and for which there is no other standard medical management or surgical option
• •Histologic confirmation of tumor is not required in the presence of consistent clinical and radiographic findings provided the following are true:
• •* No clinical observation or scan suggestive of malignant transformation
• •* Meets ≥ 1 of the following diagnostic criteria for neurofibroma type 1 (NF1):
• •* Six or more cafe-au-lait spots (\> 0.5 cm in prepubertal patients or \> 1.5 cm in post pubertal patients)
• •* Freckling in axilla or groin
• •* Optic glioma
• •* Two or more Lisch nodules
• •* A distinctive bony lesion (e.g., dysplasia of the sphenoid bone, dysplasia, or thinning of long bone cortex)
• •* A first degree relative with NF1
• •No history of malignant peripheral nerve sheath tumor
• •No active visual pathway glioma
• •No active brain tumor or brain metastases
• •PATIENT CHARACTERISTICS:
• •Performance status
• •ECOG 0-2
• •Life expectancy
• •At least 12 months
• •Hematopoietic
• •Absolute neutrophil count \> 1,500/mm\^3
• •Hemoglobin \> 10 g/dL
• •Platelet count \> 100,000/mm\^3
• •Hepatic
• •Bilirubin \< 1.5 mg/dL
• •SGPT ≤ 2 times upper limit of normal
• •No significant hepatic dysfunction
• •Renal
• •Creatinine based on age as follows:
• •* ≤ 0.8 mg/dL (for patients age 5 years and under)
• •* ≤ 1.0 mg/dL (for patients age 6 to 10 years)
• •* ≤ 1.2 mg/dL (for patients age 11 to 15 years)
• •* ≤ 1.5 mg/dL (for patients age 16 to 21 years) OR
• •Creatinine clearance ≥ 70 mL/min
• •Cardiovascular
• •No significant cardiac dysfunction
• •No severe cardiovascular disease
• •No cardiac arrhythmia requiring chronic treatment
• •No congestive heart failure
• •No symptomatic ischemic heart disease
• •Pulmonary
• •No significant pulmonary dysfunction
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No serious infection
• •No other significant unrelated systemic illness
• •No significant organ dysfunction
• •No other malignancy except surgically cured nonmelanoma skin cancer or carcinoma in situ of the cervix
• •No history of severe psychiatric condition or psychiatric disorder requiring hospitalization
• •No history of suicidal ideation or attempt
• •No thyroid dysfunction unresponsive to therapy
• •No uncontrolled diabetes mellitus
• •No history of HIV positivity
• •No alcohol or drug abuse
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •No concurrent immunotherapy
• •No concurrent colony-stimulating factors (e.g., erythropoietin or filgrastim \[G-CSF\])
• •Chemotherapy
• •No concurrent chemotherapy for this disease
• •Endocrine therapy
• •No concurrent chronic systemic corticosteroids
• •No concurrent hormonal therapy for this disease
• •Radiotherapy
• •No concurrent radiotherapy for this disease
• •Surgery
• •Prior surgery allowed provided it has been at least 21 days since surgery and there is presence of residual tumor
• •Other
• •Recovered from prior therapy
• •More than 30 days since prior investigational agents