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Combination Chemotherapy in Treating Patients With Neurofibromatosis and Progressive Plexiform Neurofibromas Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Combination Chemotherapy in Treating Patients With Neurofibromatosis and Progressive Plexiform Neurofibromas conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Neurofibromatosis and Progressive Plexiform Neurofibromas Clinical research trials and Combination Chemotherapy in Treating Patients With Neurofibromatosis and Progressive Plexiform Neurofibromas medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Combination Chemotherapy in Treating Patients With Neurofibromatosis and Progressive Plexiform Neurofibromas. Combination Chemotherapy in Treating Patients With Neurofibromatosis and Progressive Plexiform Neurofibromas Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Patients With Neurofibromatosis and Progressive Plexiform Neurofibromas clinical trial. Subjects typically recieve the finest healthcare available for their Combination Chemotherapy in Treating Patients With Neurofibromatosis and Progressive Plexiform Neurofibromas condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Neurofibromatosis and Progressive Plexiform Neurofibromas  Combination Chemotherapy in Treating Patients With Neurofibromatosis and Progressive Plexiform Neurofibromas
Combination Chemotherapy in Treating Patients With Neurofibromatosis and Progressive Plexiform Neurofibromas
For Condition: childhood neurofibrosarcoma,childhood soft tissue sarcoma
Status: Recruiting
Sponsor(s): Children's Hospital of Philadelphia ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining methotrexate with vinblastine may be effective treatment for neurofibromatosis type 1 associated with progressiveplexiform neurofibromas. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have neurofibromatosis type 1 associated with progressive plexiform neurofibromas.
Details: OBJECTIVES: - Determine the effect of chronic vinblastine and methotrexate on time to disease progression in children or young adults with progressive plexiform neurofibroma associated with neurofibromatosis type 1. - Determine the objective response rate in patients treated with this regimen. - Determine the toxic effects of this regimen in these patients. - Determine the quality of life of patients treated with this regimen. OUTLINE: Patients are stratified according to tumor status (severely debilitating and/or life-threatening vs cosmetically disfiguring). Patients receive methotrexate and vinblastine IV weekly for 26 weeks and then every 2 weeks for 26 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then every 3 months during study participation. Patients are followed every 3 months until disease progression. PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study within approximately 3 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /25 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Diagnosis of progressive, debilitating, severely disfiguring, or life-threatening plexiform neurofibroma (PN) that is surgically unresectable (or surgery refused by patient) and for which there is no other standard medical management - Histologic confirmation of tumor not required in the presence of consistent clinical and radiographic findings - Tumor must be biopsied if any clinical observation or scan suggests possible malignant transformation - Measurable disease - PN lesion that can be measured in at least 2 dimensions by direct physical examination (clinical measurement and serial photography) or MRI - Recurrent or progressive disease as documented by an increase in size or the presence of new lesions on MRI - Appearance of new tumors or a measurable increase in the sum of the product of the two longest perpendicular diameters of the index lesion(s) over a time period of no more than 12 months prior to study entry - Must meet at least one other diagnostic criteria for neurofibromatosis type 1 (NF1): - Six 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 - Two 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 - Prior therapy for NF1 or PN is not required PATIENT CHARACTERISTICS: Age: - 25 and under Performance status: - Lansky 60-100% OR - Karnofsky 60-100% Life expectancy: - At least 12 months Hematopoietic: - CBC normal - Absolute neutrophil count greater than 1,000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times normal - ALT/AST no greater than 1.5 times normal Renal: - BUN no greater than 1.5 times normal - Creatinine no greater than 1.5 times normal Other: - Not pregnant or nursing - Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 1 week since prior filgrastim (G-CSF) - No concurrent immunotherapy Chemotherapy: - At least 4 weeks since prior chemotherapy - No other concurrent chemotherapy Endocrine therapy: - 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 any prior therapy - At least 30 days since prior investigational agents
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeanBelasco, Study Chair, Children's Hospital of Philadelphia
Children's Hospital of Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Jean Belasco 215-590-2848
New York University Medical Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Jonathan Finlay 212-263-6725/6829
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390
United States
Recruiting Gail Tomlinson 214-648-4907
Additional Information:
Study ID Numbers: CDR0000069065; NCI-V01-1678,CHP-IRB-2001-2-2339,CHP-686
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030264
Other Childhood Neurofibrosarcoma Studies:
1. Flavopiridol in Treating Children With Relapsed or Refractory Solid Tumors or Lymphomas
2. Monoclonal Antibody A1G4 Plus BCG in Treating Patients With Cancer
3. Pirfenidone in Treating Young Patients With Neurofibromatosis Type 1 and Plexiform Neurofibromas
4. Surgery Followed by Chemotherapy in Treating Young Patients With Soft Tissue Sarcoma
5. Imatinib Mesylate in Treating Patients With Relapsed or Refractory Solid Tumors of Childhood
Related Studies:
Other childhood neurofibrosarcoma Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
Combination Chemotherapy in Treating Patients With Neurofibromatosis and Progressive Plexiform Neurofibromas
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