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| Tracking Information | |||||
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| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | December 1971 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00002454 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Papilloma Virus Vaccine Therapy in Treating Young Patients With Recurrent Papilloma of the Larynx | ||||
| Official Title ICMJE | Phase II Study of Immunotherapy With Autogenous Papilloma Vaccine in Patients With Recurrent Juvenile Papilloma of the Larynx | ||||
| Brief Summary | RATIONALE: Vaccines made from papilloma virus cells may make the body build an immune response to and kill papilloma cells. PURPOSE: Phase II trial to study the effectiveness of papilloma virus vaccine in treating young patients with recurrent papilloma of the larynx. |
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| Detailed Description | OBJECTIVES: I. Determine the immune response in patients with juvenile papilloma of the larynx treated with autogenous vaccine derived from each patient's own tumor. OUTLINE: Patients receive autogenous papilloma vaccine intradermally and subcutaneously weekly for 20 weeks. PROJECTED ACCRUAL: Not specified |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Precancerous/Nonmalignant Condition | ||||
| Intervention ICMJE | Biological: autologous tumor cell vaccine | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Oleske JM, Kushnick T. Juvenile papilloma of the larynx. Am J Dis Child. 1971 May;121(5):417-9. No abstract available. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Diagnosis of severe recurrent juvenile papilloma of the larynx requiring surgery at least 4 times per year Condition must have existed for more than 1 year PATIENT CHARACTERISTICS: Age: 1 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: See Disease Characteristics |
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| Gender | Both | ||||
| Ages | 1 Year and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00002454 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000071657, NJ-LAR-1, NJ-M-41-1976 | ||||
| Study Sponsor ICMJE | University of Medicine and Dentistry New Jersey | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | January 2002 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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