Clinical trial · Interventional
PEG-Interferon Alfa-2b in Treating Young Patients With Plexiform Neurofibroma
A Phase I Trial of Peginterferon Alfa-2b (PEG-Intron) for Plexiform Neurofibromas
NCT00253474CI-TRIAL-00006621completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm of Uncertain Malignant Potential | Neoplasm of Uncertain Malignant Potential | ONTOLOGY_EXACT | 0.98 |
| Unspecified Childhood Solid Tumor, Protocol Specific | Childhood Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG-interferon alfa-2a | Biological | Peginterferon Alfa-2a | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 21 Years
Show eligibility criteria text
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 agentsReferences
Publications (1)
- RESULTJakacki 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. PMID 21242495