Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

National Institutes of Health Clinical Center (CC)

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Neoplasm of Uncertain Malignant Potential

Unspecified Childhood Solid Tumor, Protocol Specific

Eligibility:

All Genders

1-21 years

Phase:

PHASE1

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 pati...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose of PEG-interferon alfa-2b in patients with unresectable plexiform neurofibroma. (Dose escalation portion of study closed to accrual as of 2...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    January 1 2011

    Estimated Enrollment :

    36 Patients enrolled

    Trial Details

    Trial ID

    NCT00253474

    Start Date

    September 1 2005

    End Date

    January 1 2011

    Last Update

    March 29 2012

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Children's National Medical Center

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

    2

    Children's Memorial Hospital - Chicago

    Chicago, Illinois, United States, 60614

    3

    Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

    Bethesda, Maryland, United States, 20892-1182

    4

    Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, United States, 15213