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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00678951 |
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. It may also stop the growth of tumor cells by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well PEG-interferon alfa-2b works in treating patients with unresectable plexiform neurofibromas associated with neurofibromatosis type 1.
Condition | Intervention | Phase |
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Neurofibromatosis Type 1 (nf1) Precancerous/Nonmalignant Condition |
Drug: PEG-interferon alfa-2b |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Peginterferon Alfa-2b (Pegintron) for Neurofibromatosis Type I Related Unresectable, Symptomatic or Life-Threatening Plexiform Neurofibromas |
Estimated Enrollment: | 87 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Strata 1 and 2: Experimental
Patients receive PEG-interferon alfa-2b subcutaneously once a week for 4 weeks. Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients who achieve a partial or complete response may continue treatment for up to 2 years.
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Drug: PEG-interferon alfa-2b
Given subcutaneously
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Stratum 3: Experimental
Patients receive PEG-interferon alfa-2b as in strata 1 and 2. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
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Drug: PEG-interferon alfa-2b
Given subcutaneously
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to disease status (plexiform neurofibromas [PN] with no clinical symptoms and no documented radiographic progression [stratum 1] vs PN with clinical symptoms but no documented radiographic progression [stratum 2] vs PN with documented radiographic progression with or without clinical symptoms [stratum 3]).
Patients undergo 3-dimensional MRI (3-D MRI) at baseline, at 4, 8, and 12 months, and then every 6 months thereafter for volumetric analysis of their plexiform neurofibromas. Volume measurements will be compared with conventional 2-D MRI analysis and 1-D MRI analysis to assess the reproducibility and sensitivity of 3-D MRI in determining disease status of plexiform neurofibromas.
Ages Eligible for Study: | 1 Year to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed* neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas (PN) that are inoperable AND have the potential to cause significant morbidity including, but not limited to, any of the following:
Patients with PN that has not been histologically confirmed must have ≥ 1 other diagnostic criteria for NF1 (according to NIH Consensus Conference criteria), including any of the following:
Meets 1 of the following criteria:
Progressive PN (with or without clinical symptoms), as defined by 1 of the following (stratum 3):
Measurable residual tumor
PATIENT CHARACTERISTICS:
Creatinine clearance ≥ 70 mL/min OR serum creatinine normal based on age as follows:
No severe cardiovascular disease, including any of the following:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Principal Investigator: | Brigitte C. Widemann, MD | NCI - Pediatric Oncology Branch |
Study ID Numbers: | CDR0000595749, NCI-08-C-0130, NCI-P06096 |
Study First Received: | May 14, 2008 |
Last Updated: | January 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00678951 |
Health Authority: | Unspecified |
plexiform neurofibroma neurofibromatosis type 1 (NF1) |
Interferon-alpha Precancerous Conditions Interferons Neurodegenerative Diseases Neurofibromatosis type 1 Neurofibromatosis 1 Neoplastic Syndromes, Hereditary Heredodegenerative Disorders, Nervous System Genetic Diseases, Inborn Neurofibroma Neuromuscular Diseases |
Peripheral Nervous System Diseases Peginterferon alfa-2b Neurofibromatoses Peripheral Nervous System Neoplasms Interferon Alfa-2a Neurofibroma, Plexiform Interferon Alfa-2b Nerve Sheath Neoplasms Nervous System Neoplasms Neurocutaneous Syndromes |
Anti-Infective Agents Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Growth Substances Neoplasms, Nerve Tissue Nervous System Diseases Physiological Effects of Drugs |
Antiviral Agents Angiogenesis Inhibitors Pharmacologic Actions Neoplasms Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |