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Home > "T" Clinical Trials Conditions > Tipifarnib in Preventing Cancer in Children With Neurofibromatosis Type 1 and Progressive Plexiform Neurofibromas  Tipifarnib in Preventing Cancer in Children With Neurofibromatosis Type 1 and Progressive Plexiform Neurofibromas
Tipifarnib in Preventing Cancer in Children With Neurofibromatosis Type 1 and Progressive Plexiform Neurofibromas
For Condition: childhood soft tissue sarcoma,childhood neurofibrosarcoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. Tipifarnib may be effective in preventing the development of cancer in patients who have neurofibromatosis type 1 and plexiform neurofibromas. PURPOSE: Randomizedphase II trial to study the effectiveness of tipifarnib in preventing cancer in young patients who have neurofibromatosis type 1 and progressive plexiform neurofibromas.
Details: OBJECTIVES: - Determine the effect of tipifarnib on the time to disease progression in pediatric patients with neurofibromatosis type 1 and progressive plexiform neurofibromas. - Determine the objective response rate in patients treated with this regimen. - Determine the toxic effects of this regimen in these patients. - Assess the quality of life of patients treated with this regimen. - Determine the circulating levels of nerve growth factor and correlate these levels with the development of clinical neurotoxicity in patients treated with this regimen. OUTLINE: This is a randomized, cross-over, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 arms. - Arm I: Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I. After documentation of disease progression, patients on both arms cross over to the other arm and (after a 2-week washout period) receive treatment as above in the absence of further disease progression or unacceptable toxicity. Quality of life is assessed at baseline, prior to courses 4, 7, and 10, and then after every 6 courses thereafter. PROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 3 years.
Eligibility:
Study Type: Interventional, Prevention
Minimum Age/Maximum Age: 3 Years/25 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of neurofibromatosis type 1 (NF1) AND - Progressive plexiform neurofibromas - Neurofibromas that have grown along the length of a nerve and may involve multiple fascicles and branches (spinal neurofibromas involve 2 or more levels with connection between the levels or extending laterally along the nerve) - Potential to cause significant morbidity such as: - Head and neck lesions that could compromise airway or great vessels - Brachial or lumbar plexus lesions that could cause nerve compression and loss of function - Lesions that could result in major deformity (e.g., orbital lesions) - Lesions of the limb that cause limb hypertrophy or loss of function - Painful lesions - Meets at least 1 other diagnostic criteria for NF1 - 6 or more cafe-au-lait spots (at least 0.5 cm in prepubertal patients or at least 1.5 cm in postpubertal patients) - Freckling in the axilla or groin - Optic glioma - 2 or more Lisch nodules - Distinctive bony lesion (dysplasia of the sphenoid bone or dysplasia or thinning of long bone cortex) - First-degree relative with NF1 - Measurable plexiform neurofibromas - At least 3 cm in one dimension - Evidence of recurrent or progressive disease as documented by an increase in size or the presence of new plexiform neurofibromas on MRI - No evidence of an optic glioma, malignant glioma, malignant peripheral nerve sheath tumor, or other cancer requiring chemotherapy or radiotherapy - Prior surgery for progressive plexiform neurofibroma allowed provided neurofibroma was incompletely resected and is measurable - Complete tumor resection not feasible or patient refused surgery PATIENT CHARACTERISTICS: Age: - 3 to 25 Performance status: - ECOG 0-2 Life expectancy: - At least 12 months Hematopoietic: - Absolute granulocyte count at least 1,500/mm^3 - Hemoglobin at least 9.0 g/dL - Platelet count at least 150,000/mm^3 - Fibrinogen normal Hepatic: - Bilirubin normal unless due to Gilbert's syndrome - SGPT no greater than 2 times upper limit of normal - No significant hepatic dysfunction Renal: - Creatinine normal for age OR - Creatinine clearance at least 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 - No clinically significant unrelated systemic illness that would preclude study participation - No serious infections - No significant organ dysfunction - No metal implanted prostheses (e.g., vascular clamps or pacemakers) that would contraindicate an MRI PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 1 week since prior filgrastim (G-CSF) - No concurrent anticancer immunotherapy Chemotherapy: - See Disease Characteristics - No more than 1 prior myelosuppressive chemotherapy regimen - At least 4 weeks since prior chemotherapy and recovered - No concurrent anticancer chemotherapy Endocrine therapy: - No concurrent anticancer hormonal therapy Radiotherapy: - See Disease Characteristics - At least 6 weeks since prior radiotherapy and recovered - No concurrent anticancer radiotherapy Surgery: - See Disease Characteristics Other: - No prior tipifarnib - At least 30 days since prior investigational agents - No concurrent proton pump inhibitors (e.g., omeprazole, lansoprazole, pantoprazole, rabeprazole, or esomeprazole) - No other concurrent investigational anticancer agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BrigitteWidemann, Study Chair, Pediatric Oncology Branch
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Alyssa Reddy 205-939-9285
Hospital for Sick Children *Recruiting*
Toronto, Ontario, M5G 1X8
Canada
Recruiting Douglas Hyder 416-813-7758
Klinikum Nord *Recruiting*
Hamburg, , 22419
Germany
Recruiting Victor Mautner 49-040-5271-2872
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Jean Belasco 215-590-2848
Siteman Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting Arie Perry 314-362-9130
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231-2410
United States
Recruiting Robert Arceci 410-502-7519
Additional Information:
Study ID Numbers: CDR0000068922; NCI-01-C-0222G,NCI-T99-0090
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00029354
Other Childhood Soft Tissue Sarcoma Studies:
1. Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors
2. Genetic Study of Children With Soft Tissue Sarcoma or Rhabdomyosarcoma
3. Monoclonal Antibody A1G4 Plus BCG in Treating Patients With Cancer
4. Imatinib Mesylate in Treating Patients With Relapsed or Refractory Solid Tumors of Childhood
5. Pirfenidone in Treating Young Patients With Neurofibromatosis Type 1 and Plexiform Neurofibromas
Related Studies:
Other childhood soft tissue sarcoma Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Tipifarnib in Preventing Cancer in Children With Neurofibromatosis Type 1 and Progressive Plexiform Neurofibromas
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