Papilloma Virus Vaccine Therapy in Treating Young Patient... | NCT00002454

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

NCT00002454

Sponsor

University of Medicine and Dentistry of New Jersey

Status

Unknown status

Last Update Posted

Jul 26, 2011Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Precancerous Condition

Interventions

autologous tumor cell vaccine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2002

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1971

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Nov 1, 1999

First Submission Date that Met QC Criteria

Feb 26, 2004

First Posted Date

Feb 27, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2011

Last Update Posted Date

Jul 26, 2011Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
autologous tumor cell vaccine	Biological

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James M. Oleske, MD	Rutgers, The State University of New Jersey	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New Jersey Medical School		Newark	New Jersey	07103-2714	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Result	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.
4326367	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.

Type	Date	Date Unknown
Release	Oct 4, 2016
Reset	Nov 25, 2016
Release	Apr 10, 2017
Reset	Jun 23, 2017
Release	Sep 28, 2017
Reset	Jul 16, 2018

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Oct 4, 2016			Nov 25, 2016
Apr 10, 2017

ID	Type	Description	Link
NJ-LAR-1
NJ-M-41-1976