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

This study is ongoing, but not recruiting participants.

First Received: November 1, 1999 Last Updated: February 6, 2009 History of Changes

Sponsored by:	University of Medicine and Dentistry New Jersey
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00002454

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/Nonmalignant Condition	Biological: autologous tumor cell vaccine	Phase II

Study Type:	Interventional
Study Design:	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:

MedlinePlus related topics: Cancer

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:

Oleske J, Fishman D, Cooper R, et al.: Autogenous vaccine in the treatment of laryngeal papilloma. Proceeding of the 12th International Congress of Chemotherapy pp 1099-1101, 1981.

Oleske JM, Kushnick T. Juvenile papilloma of the larynx. Am J Dis Child. 1971 May;121(5):417-9. No abstract available.

Study ID Numbers:	CDR0000071657, NJ-LAR-1, NJ-M-41-1976
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00002454 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

lung papilloma

Study placed in the following topic categories:

Virus Diseases
Precancerous Conditions
Neoplasms, Squamous Cell

Papilloma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Precancerous Conditions

Neoplasms, Squamous Cell
Papilloma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 01, 2009