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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00326872 |
RATIONALE: 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.
PURPOSE: 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.
Condition | Intervention | Phase |
---|---|---|
Neurofibromatosis Type 1 (nf1) Precancerous/Nonmalignant Condition |
Drug: cediranib maleate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of AZD2171 in Adult Patients With Neurofibromatosis Type 1 and Extensive Plexiform and Paraspinal Neurofibromas |
Estimated Enrollment: | 65 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to tumor location (peripheral vs paraspinal plexiform neurofibroma).
Patients receive oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, prior to course 2, prior to course 4, and every 6 courses thereafter.
PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis* of neurofibromatosis type 1 (NF1) and extensive plexiform and/or paraspinal neurofibromas producing pain (not controlled by use of over-the-counter medications), progressive neurologic deficit, or significant neurologic consequences with 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
Meets ≥ 2 diagnostic criteria for NF1, including the following:
Measurable disease, defined as ≥ 1 lesion whose longest diameter can be accurately measured as 8.0 cm^3 with 3-dimensional (3D) MRI
PATIENT CHARACTERISTICS:
No other uncontrolled, serious medical condition that would preclude study participation, including any of the following:
No New York Heart Association class III or IV disease
PRIOR CONCURRENT THERAPY:
United States, Alabama | |
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: Clinical Trials Office - Lurleen Wallace Comprehensive Cancer 205-934-0309 | |
United States, District of Columbia | |
Howard University Cancer Center | Recruiting |
Washington, District of Columbia, United States, 20060 | |
Contact: Clinical Trials Office - Howard University Cancer Center 202-806-9122 | |
United States, Illinois | |
University of Chicago Cancer Research Center | Recruiting |
Chicago, Illinois, United States, 60637-1470 | |
Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201-1379 | |
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis | Recruiting |
Saint Louis, Missouri, United States, 63110-4803 | |
Contact: Gerald P. Linette, MD, PhD 314-747-7222 | |
United States, Ohio | |
Case Comprehensive Cancer Center | Recruiting |
Cleveland, Ohio, United States, 44106-5065 | |
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422 |
Study Chair: | Dusica Babovic-Vuksanovic, MD | Mayo Clinic |
Responsible Party: | Mayo Clinic Cancer Center ( Charles Erlichman ) |
Study ID Numbers: | CDR0000475761, MAYO-MC047F, NCI-7133 |
Study First Received: | May 16, 2006 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00326872 History of Changes |
Health Authority: | Unspecified |
neurofibromatosis type 1 (NF1) plexiform neurofibroma spinal cord neurofibroma |
Precancerous Conditions Neurodegenerative Diseases Neurofibromatosis 1 Neoplastic Syndromes, Hereditary Heredodegenerative Disorders, Nervous System Neurofibromatosis Type 1 Genetic Diseases, Inborn Neurofibroma |
Neuromuscular Diseases Peripheral Nervous System Diseases Neurofibromatoses Peripheral Nervous System Neoplasms Neurofibroma, Plexiform Nerve Sheath Neoplasms Nervous System Neoplasms Neurocutaneous Syndromes |
Neoplasms by Histologic Type Precancerous Conditions Neoplasms, Nerve Tissue Nervous System Diseases Neurodegenerative Diseases Neurofibromatosis 1 Neoplasms Heredodegenerative Disorders, Nervous System Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn |
Neuromuscular Diseases Neurofibroma Peripheral Nervous System Diseases Neurofibromatoses Peripheral Nervous System Neoplasms Neurofibroma, Plexiform Nerve Sheath Neoplasms Nervous System Neoplasms Neurocutaneous Syndromes |