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Papilloma Virus Vaccine Therapy in Treating Young Patients With Recurrent Papilloma of the Larynx

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002454
First received: November 1, 1999
Last updated: July 23, 2011
Last verified: January 2002
History of Changes
  Purpose

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.


Condition Intervention Phase
Precancerous Condition
 Biological: autologous tumor cell vaccine
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Immunotherapy With Autogenous Papilloma Vaccine in Patients With Recurrent Juvenile Papilloma of the Larynx

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 1971
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

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002454

Locations
United States, New Jersey
New Jersey Medical School
Newark, New Jersey, United States, 07103-2714
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
Study Chair: James M. Oleske, MD University of Medicine and Dentistry New Jersey
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00002454     History of Changes
Other Study ID Numbers: CDR0000071657, NJ-LAR-1, NJ-M-41-1976
Study First Received: November 1, 1999
Last Updated: July 23, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
lung papilloma

Additional relevant MeSH terms:
Papilloma
Precancerous Conditions
Neoplasms, Squamous Cell
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 22, 2013