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

Primary Purpose

Precancerous Condition

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

autologous tumor cell vaccine

About this trial

This is an interventional treatment trial for Precancerous Condition focused on measuring lung papilloma

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

New Jersey Medical School

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00002454

First Posted

November 1, 1999

Last Updated

July 23, 2011

Sponsor

University of Medicine and Dentistry of New Jersey

1. Study Identification

Unique Protocol Identification Number

NCT00002454

Brief Title

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

Official Title

Phase II Study of Immunotherapy With Autogenous Papilloma Vaccine in Patients With Recurrent Juvenile Papilloma of the Larynx

Study Type

Interventional

2. Study Status

Record Verification Date

January 2002

Overall Recruitment Status

Unknown status

Study Start Date

December 1971 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University of Medicine and Dentistry of New Jersey

4. Oversight

5. Study Description

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.

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Precancerous Condition

Keywords

lung papilloma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

autologous tumor cell vaccine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James M. Oleske, MD

Organizational Affiliation

Rutgers, The State University of New Jersey

Official's Role

Study Chair

Facility Information:

Facility Name

New Jersey Medical School

City

Newark

State/Province

New Jersey

ZIP/Postal Code

07103-2714

Country

United States

12. IPD Sharing Statement

Citations:

Citation

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.

Results Reference

result

PubMed Identifier

4326367

Citation

Oleske JM, Kushnick T. Juvenile papilloma of the larynx. Am J Dis Child. 1971 May;121(5):417-9. doi: 10.1001/archpedi.1971.02100160087011. No abstract available.

Results Reference

result

Learn more about this trial

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

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