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Pirfenidone in Treating Young Patients With Neurofibromatosis Type I and Recurrent or Progressive Plexiform Neurofibromas Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Pirfenidone in Treating Young Patients With Neurofibromatosis Type I and Recurrent or Progressive Plexiform Neurofibromas conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Pirfenidone in Treating Young Patients With Neurofibromatosis Type I and Recurrent or Progressive Plexiform Neurofibromas Clinical research trials and Pirfenidone in Treating Young Patients With Neurofibromatosis Type I and Recurrent or Progressive Plexiform Neurofibromas medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Pirfenidone in Treating Young Patients With Neurofibromatosis Type I and Recurrent or Progressive Plexiform Neurofibromas. Pirfenidone in Treating Young Patients With Neurofibromatosis Type I and Recurrent or Progressive Plexiform Neurofibromas Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Pirfenidone in Treating Young Patients With Neurofibromatosis Type I and Recurrent or Progressive Plexiform Neurofibromas clinical trial. Participants frequently get the best healthcare available for their Pirfenidone in Treating Young Patients With Neurofibromatosis Type I and Recurrent or Progressive Plexiform Neurofibromas condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "P" Clinical Trials Conditions > Pirfenidone in Treating Young Patients With Neurofibromatosis Type I and Recurrent or Progressive Plexiform Neurofibromas  Pirfenidone in Treating Young Patients With Neurofibromatosis Type I and Recurrent or Progressive Plexiform Neurofibromas
Pirfenidone in Treating Young Patients With Neurofibromatosis Type I and Recurrent or Progressive Plexiform Neurofibromas
For Condition: neurofibromatosis 1 and 2 (NF1 and NF2)
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: 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 progressiveplexiform neurofibroma.
Details: OBJECTIVES: Primary - Determine the time to disease progression in pediatric patients with neurofibromatosis type 1 (NF1) and recurrent or progressive plexiform neurofibroma treated with pirfenidone. - Determine the objective response rate in patients treated with this drug. - Determine the toxicity of this drug in these patients. Secondary - Determine the quality of life of patients treated with this drug. OUTLINE: This is an open-label, multicenter study. Patients receive oral pirfenidone three times daily on days 1-28. Courses repeat every 28 days 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 course 4, and then after every 6 courses. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 12-14 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/21 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - All of the following: - Diagnosis of neurofibromatosis type 1 (NF1) - 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: - At least 20% increase in volume - At least 13% increase in the product of the 2 longest perpendicular diameters - At least 6% increase in the longest diameter - Measurable lesion at least 3 cm in 1 dimension - Meets 1 or more of the following other diagnostic criteria for NF1: - At least 6 cafe-au-lait spots - At least 0.5 cm in prepubertal patients - At least 1.5 cm in postpubertal patients - Freckling in the axilla or groin - Optic glioma - At least 2 Lisch nodules - One of the following distinctive bony lesions: - Dysplasia of the sphenoid bone - Dysplasia of the long bone cortex - Thinning of the long bone cortex - One first-degree relative with NF1 - Ineligible for or refused complete resection of plexiform neurofibroma - Prior surgery for progressive disease allowed provided the plexiform neurofibroma was incompletely resected and is measurable - No evidence of malignant glioma or malignant peripheral nerve sheath tumor PATIENT CHARACTERISTICS: Age - 3 to 21 Performance status - Karnofsky 50-100% (over 10 years of age) OR - Lansky 50-100% (10 years of age and under) Life expectancy - At least 12 months Hematopoietic - Absolute granulocyte count 1,500/mm^3* - Hemoglobin 9 g/dL* - Platelet count 150,000/mm^3* NOTE: *Transfusion independent Hepatic - Bilirubin normal (except for patients with Gilbert's syndrome) - SGPT 2 times upper limit of normal - No significant hepatic dysfunction Renal - Creatinine normal OR - Creatinine clearance 70 mL/min Cardiovascular - No significant cardiac dysfunction Pulmonary - No significant pulmonary dysfunction Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 2 months after study treatment - Able to take pirfenidone by mouth - Able to undergo MRI - No clinically significant unrelated systemic illness that would preclude study participation - No serious infection - No other significant organ dysfunction - No other cancer requiring treatment with chemotherapy or radiotherapy PRIOR CONCURRENT THERAPY: Biologic therapy - At least 1 week since prior filgrastim (G-CSF) - No prior pirfenidone - No concurrent immunotherapy - No concurrent biologic therapy (e.g., interferon) - No concurrent hematopoietic growth factors Chemotherapy - At least 4 weeks since prior chemotherapy - No concurrent chemotherapy Endocrine therapy - Concurrent corticosteroids allowed - No concurrent hormonal therapy directed at the tumor Radiotherapy - At least 6 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - See Disease Characteristics Other - Recovered from prior therapy (toxicity level less than grade 2) - More than 30 days since prior investigational agents - No other concurrent investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrigitteWidemann, Principal Investigator, Pediatric Oncology Branch
Children's National Medical Center *Recruiting*
Washington D.C., District of Columbia, 20010-2970
United States
Recruiting Roger Packer 202-884-2120
Children's Hospital of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Regina Jakacki 412-692-5055
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Robert Arceci 410-502-7518
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Jean Belasco 215-590-2848
Texas Children's Cancer Center *Recruiting*
Houston, Texas, 77030-2399
United States
Recruiting Susan Blaney 832-822-4215
Children's Memorial Hospital - Chicago *Recruiting*
Chicago, Illinois, 60614
United States
Recruiting Stewart Goldman 773-880-4598 ext. 3270
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905
United States
Recruiting Dusica Babovic-Vuksanovic 507-284-3215
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting Bruce Cohen 216-444-9182
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Alyssa Reddy 205-939-9285
Washington University Medical Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Allison King 314-454-4291
University Hospital at State University of New York - Upstate Medical University *Recruiting*
Syracuse, New York, 13210
United States
Recruiting Ronald Dubowy 315-464-5294
Cancer Institute at Oregon Health and Science University *Recruiting*
Portland, Oregon, 97239-3098
United States
Recruiting H. Nicholson 503-494-1543
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Mark Kieran 617-632-4907
Beth Israel Medical Center - Singer Division *Recruiting*
New York City, New York, 10128
United States
Recruiting Jeffrey Allen 212-870-9407
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Additional Information:
Study ID Numbers: CDR0000353200; NCI-04-C-0080
Study Start Date:
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00078936
Other Neurofibromatosis 1 And 2 (nf1 And Nf2) Studies:
1. Pirfenidone in Treating Young Patients With Neurofibromatosis Type I and Recurrent or Progressive Plexiform Neurofibromas
2. Fludeoxyglucose F 18 Positron Emission Tomography and Magnetic Resonance Perfusion Imaging in Patients With Neurofibromatosis 1 and Plexiform Neurofibroma
Related Studies:
Other neurofibromatosis 1 and 2 (NF1 and NF2) Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Pirfenidone in Treating Young Patients With Neurofibromatosis Type I and Recurrent or Progressive Plexiform Neurofibromas
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