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

NCT ID: NCT00002454

Last Updated: 2011-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

1971-12-31

Brief Summary

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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

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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

Conditions

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Precancerous Condition

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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autologous tumor cell vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Medicine and Dentistry of New Jersey

OTHER

Sponsor Role lead

Principal Investigators

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James M. Oleske, MD

Role: STUDY_CHAIR

Rutgers, The State University of New Jersey

Locations

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New Jersey Medical School

Newark, New Jersey, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT

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.

Reference Type RESULT
PMID: 4326367 (View on PubMed)

Other Identifiers

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NJ-LAR-1

Identifier Type: -

Identifier Source: secondary_id

NJ-M-41-1976

Identifier Type: -

Identifier Source: secondary_id

CDR0000071657

Identifier Type: -

Identifier Source: org_study_id

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