Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Trial of Peginterferon Alfa-2b (PEG-Intron) for Plexiform Neurofibromas
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon
alfa-2b in treating young patients with plexiform neurofibroma.
Status | Completed |
Enrollment | 36 |
Est. completion date | January 2011 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Year to 21 Years |
Eligibility |
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 |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | Bethesda | Maryland |
United States | Children's Memorial Hospital - Chicago | Chicago | Illinois |
United States | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Children's National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
National Institutes of Health Clinical Center (CC) | National Cancer Institute (NCI) |
United States,
Jakacki RI, Dombi E, Potter DM, Goldman S, Allen JC, Pollack IF, Widemann BC. Phase I trial of pegylated interferon-alpha-2b in young patients with plexiform neurofibromas. Neurology. 2011 Jan 18;76(3):265-72. doi: 10.1212/WNL.0b013e318207b031. — View Citation
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