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Trial record 48 of 295 for:    IFNA2 AND PEG-interferon alfa-2b

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

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ClinicalTrials.gov Identifier: NCT00253474
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : March 29, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Institutes of Health Clinical Center (CC)

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.


Condition or disease Intervention/treatment Phase
Neoplasm of Uncertain Malignant Potential Unspecified Childhood Solid Tumor, Protocol Specific Biological: PEG-interferon alfa-2a Phase 1

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 2/2005.)
  • Determine the toxicity profile of this drug in these patients.

Secondary

  • Obtain, preliminary, information about the efficacy of this drug in these patients.
  • Evaluate the growth rate of plexiform neurofibroma using volumetric MRI analysis in patients treated with this drug.
  • Evaluate the impact of this drug, in terms of "worst symptom" score, in these patients.

OUTLINE: This is a dose-escalation, multicenter study. (Dose-escalation portion of the study closed to accrual as of 2/2005.)

Patients receive PEG-interferon alfa-2b subcutaneously once weekly for 2 years in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of PEG-interferon alfa-2b until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 6 patients experience dose-limiting toxicity. A total of 12 patients receive treatment at the MTD.

After completion of study treatment, patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Primary Purpose: Treatment
Official Title: A Phase I Trial of Peginterferon Alfa-2b (PEG-Intron) for Plexiform Neurofibromas
Study Start Date : September 2005
Actual Study Completion Date : January 2011






Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253474


Locations
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United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010-2970
United States, Illinois
Children's Memorial Hospital - Chicago
Chicago, Illinois, United States, 60614
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, Pennsylvania
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Brigitte C. Widemann, MD National Cancer Institute (NCI)

Publications of Results:
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ClinicalTrials.gov Identifier: NCT00253474     History of Changes
Obsolete Identifiers: NCT00156754
Other Study ID Numbers: 050232
05-C-0232
NCI-P6670
CDR0000448811
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: March 29, 2012
Last Verified: March 2012
Keywords provided by National Institutes of Health Clinical Center (CC):
neoplasm of uncertain malignant potential
unspecified childhood solid tumor, protocol specific
Additional relevant MeSH terms:
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Interferon-alpha
Interferon alpha-2
Peginterferon alfa-2a
Neurofibroma
Neurofibroma, Plexiform
Neoplasms
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Interferons
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs