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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. The completion date has passed and the status has not been verified in more than two years.
Verified January 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00002454
First Posted: February 27, 2004
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 of New Jersey
Investigators
Study Chair: James M. Oleske, MD Rutgers, The State University of New Jersey
  More Information

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

ClinicalTrials.gov Identifier: NCT00002454     History of Changes
Other Study ID Numbers: CDR0000071657
NJ-LAR-1
NJ-M-41-1976
First Submitted: November 1, 1999
First Posted: February 27, 2004
Last Update Posted: October 12, 2017
Last Verified: January 2002

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs