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

NCT00253474 | Completed Phase 1

• 4 other identifiers: 05023205-C-0232NCI-P6670CDR0000448811
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 4

Brief Summary

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

Neoplasm of Uncertain Malignant Potential; Unspecified Childhood Solid Tumor, Protocol Specific

Keywords

neoplasm of uncertain malignant potential; unspecified childhood solid tumor, protocol specific

Interventions

PEG-interferon alfa-2a BIOLOGICAL

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Children's National Medical Center

Washington D.C., District of Columbia, 20010-2970, United States

Location

Children's Memorial Hospital - Chicago

Chicago, Illinois, 60614, United States

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• 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.

  PMID: 21242495 RESULT

MeSH Terms

Interventions

peginterferon alfa-2a

Study Officials

• Brigitte C. Widemann, MD

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 11, 2005
• First Posted: November 15, 2005
• Study Start: September 1, 2005
• Study Completion: January 1, 2011
• Last Updated: March 29, 2012

Record last verified: 2012-03

Locations

US (4)