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| Sponsored by: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00078936 |
Purpose
RATIONALE: Some tumors need growth factors produced by the body's white blood cells to keep growing. Pirfenidone may interfere with growth factors and stop the tumor from growing.
PURPOSE: Phase II trial to study the effectiveness of pirfenidone in treating young patients who have neurofibromatosis type 1 and recurrent or progressive plexiform neurofibroma.
| Condition | Intervention | Phase |
|
Neurofibromatosis Type 1 (nf1) Precancerous/Nonmalignant Condition |
Drug: pirfenidone |
Phase II |
| Genetics Home Reference related topics: | neurofibromatosis type 1 |
| MedlinePlus related topics: | Cancer Neurofibromatosis |
| ChemIDplus related topics: | Pirfenidone |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Trial Of Pirfenidone In Children, Adolescents, And Young Adults With Neurofibromatosis Type I And Progressive Plexiform Neurofibromas |
| Estimated Enrollment: | 36 |
| Study Start Date: | October 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, multicenter study.
Patients receive oral pirfenidone three times daily continuously for a course of 28 days. Courses repeat in the absence of disease progression or unacceptable toxicity.
For patients 6 to 18 years of age, quality of life is assessed at baseline, before courses 4 and 7, and then after every 6 courses.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 12-14 months.
Eligibility
| Ages Eligible for Study: | 3 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
All of the following:
Histologically confirmed OR consistent clinical and radiographic findings of plexiform neurofibroma (defined as neurofibroma that has grown along the length of a nerve and may involve multiple fascicles and branches)
Recurrent disease (presence of new lesion) or progressive disease as documented on last 2 consecutive MRI or CT scans or within the past year by 1 of the following:
Meets 1 or more of the following other diagnostic criteria for NF1:
At least 6 cafe-au-lait spots
One of the following distinctive bony lesions:
Ineligible for or refused complete resection of plexiform neurofibroma
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| 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 | |||||
| Children's National Medical Center | Recruiting | ||||
| Washington, District of Columbia, United States, 20010-2970 | |||||
| Contact: Clinical Trials Office - Children's National Medical Center 202-884-2549 | |||||
| United States, Illinois | |||||
| Children's Memorial Hospital - Chicago | Recruiting | ||||
| Chicago, Illinois, United States, 60614 | |||||
| Contact: Stewart Goldman, MD 773-880-4585 | |||||
| United States, Maryland | |||||
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting | ||||
| Baltimore, Maryland, United States, 21231-2410 | |||||
| Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu | |||||
| 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 | |||||
| United States, Massachusetts | |||||
| Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | Recruiting | ||||
| Boston, Massachusetts, United States, 02115 | |||||
| Contact: Clinical Trials Office - Dana-Farber/Harvard Cancer Center 617-582-8480 | |||||
| United States, Minnesota | |||||
| Mayo Clinic Cancer Center | Recruiting | ||||
| Rochester, Minnesota, United States, 55905 | |||||
| Contact: Dusica Babovic-Vuksanovic, MD 507-284-2511 | |||||
| United States, Missouri | |||||
| St. Louis Children's Hospital | Recruiting | ||||
| Saint Louis, Missouri, United States, 63110 | |||||
| Contact: Allison King, MD 314-454-6018 | |||||
| United States, New York | |||||
| Beth Israel Medical Center - Singer Division | Recruiting | ||||
| New York, New York, United States, 10028 | |||||
| Contact: Jeffrey C. Allen, MD 212-263-6725 | |||||
| SUNY Upstate Medical University Hospital | Recruiting | ||||
| Syracuse, New York, United States, 13210 | |||||
| Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476 | |||||
| United States, Ohio | |||||
| Cleveland Clinic Taussig Cancer Center | Recruiting | ||||
| Cleveland, Ohio, United States, 44195 | |||||
| Contact: Clinical Trials Office - Cleveland Clinic Taussig Cancer Cente 866-223-8100 | |||||
| United States, Pennsylvania | |||||
| Children's Hospital of Philadelphia | Recruiting | ||||
| Philadelphia, Pennsylvania, United States, 19104 | |||||
| Contact: Jean B. Belasco, MD 215-590-2800 | |||||
| Children's Hospital of Pittsburgh | Recruiting | ||||
| Pittsburgh, Pennsylvania, United States, 15213 | |||||
| Contact: Clinical Trials Office - Children's Hospital of Pittsburgh 412-692-5573 | |||||
| United States, Texas | |||||
| Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital | Recruiting | ||||
| Houston, Texas, United States, 77030-2399 | |||||
| Contact: Susan M. Blaney, MD 832-822-1482 sblaney@txccc.org | |||||
| Principal Investigator: | Brigitte C. Widemann, MD | NCI - Pediatric Oncology Branch |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000353200, NCI-04-C-0080 |
| First Received: | March 8, 2004 |
| Last Updated: | May 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00078936 |
| Health Authority: | Unspecified |
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