AZD2171 in Treating Patients With Neurofibromatosis Type 1 and Plexiform Neurofibroma and/or Neurofibroma Near the Spine

Stopped early · Phase 2

Conditions studied: Neurofibromatosis Type 1, Plexiform Neurofibroma, Spinal Cord Neurofibroma

In brief

This phase II trial is studying how well AZD2171 works in treating patients with neurofibromatosis type 1 and plexiform neurofibroma and/or neurofibroma near the spine. AZD2171 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Key facts

Study ID

NCT00326872

Run by

National Cancer Institute (NCI)

People needed

26

Starts

2006-05-01

Expected to finish

2016-05-31

Last updated by the study team

2017-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis* of neurofibromatosis type 1 (NF1) and extensive plexiform and/or paraspinal neurofibromasproducing pain (not controlled by use of over-the-counter medications), progressive neurologic deficit, or significant neurologic consequenceswith continuous tumor growth
• Extensive paraspinal neurofibroma defined as a neurofibroma that involves multiple neural roots at ≥ 3 spinal levels with connection between the levels or extending laterally along the nerves
• Symptomatic neurofibromas at < 3 spinal levels, but surgical treatment is not possible, allowed
• Meets ≥ 2 diagnostic criteria for NF1, including the following:
• Six or more café-au-lait spots (≥ 1.5 cm in postpubertal patients)
• Freckling in the axilla or groin
• Optic glioma
• Two or more Lisch nodules
• Distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia orthinning of long-bone cortex)
• First-degree relative with NF1
• Patients with documented mutation in neurofibromin gene with onlysymptomatic plexiform and/or paraspinal neurofibroma who do not fulfill the above clinical criteria are eligible
• Measurable disease, defined as ≥ 1 lesion whose longest diameter can beaccurately measured as 8.0 cm\^3 with 3-dimensional (3D) MRI
• Skin lesions are consideredmeasurable (e.g., plexiform neurofibromas), but MRI imaging still required for 3D measurement
• Patients with symptomatic neurofibroma, in whom surgery is not feasible, who refuse surgery or are not goodsurgical candidates due to high risk of damage to vital structures or spinal cordinjury are eligible
• No evidence of progressive optic glioma, malignant glioma, malignant peripheralnerve sheath tumor, or other cancer requiring treatment with chemotherapy orradiotherapy
• ECOG performance status 0-3
• WBC ≥ 3,000/mm\^3
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hemoglobin ≥ 8.0 g/dL
• Bilirubin normal (patients with Gilbert's syndrome allowed despite elevated bilirubin)
• Alkaline phosphatase normal
• AST and ALT ≤ 2.5 times upper limit of normal
• Thyroid-stimulating hormone and free thyroxin normal
• Creatinine normal OR creatinine clearance ≥ 60 mL/min

Where it is running

• University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
• Howard University Hospital — Washington D.C., District of Columbia, United States
• University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Wayne State University/Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Case Western Reserve University — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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