NCT00002916

Brief Summary

RATIONALE: Vaccines made from human papillomavirus may make the body build an immune response to and kill cervical cancer cells. Combining vaccine therapy with surgery may be a more effective treatment for cervical cancer. PURPOSE: This phase II trial is studying how well giving vaccine therapy together with surgery works in treating patients with early cervical cancer.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
7 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1996

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

July 2, 2012

Status Verified

June 1, 2012

First QC Date

November 1, 1999

Last Update Submit

June 29, 2012

Conditions

Cervical Cancer

Keywords

stage IB cervical cancerstage IIA cervical cancercervical squamous cell carcinomacervical adenocarcinomacervical adenosquamous cell carcinoma

Outcome Measures

Primary Outcomes (2)

  • Immunological response to HPV

  • Toxicity and safety of TA-HPV

Secondary Outcomes (2)

  • Proliferative capacity of T-cells to the E6 and E7 proteins

  • Influence of vaccination with TA-HPV on the disease free interval or patterns of recurrence

Interventions

human papillomavirus 16 E7 peptideBIOLOGICAL
synthetic human papillomavirus 16 E6 peptideBIOLOGICAL
adjuvant therapyPROCEDURE
surgical procedurePROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age19 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven untreated stage Ib or IIa cervical carcinoma, squamous or adenocarcinoma suitable for surgical excision * No CNS metastases * Circulating CD4+ lymphocyte count at least 400 * Proven absence of hepatitis B and C antibodies * Previous exposure to vaccinia from smallpox vaccination, as well as no previous exposure, is allowed * Reaction to 2 or more antigens on Pasteur Merieux CMI test required * Ability to collaborate planned follow-up required PATIENT CHARACTERISTICS: Age: * 19 and over Performance status: * WHO/ECOG no greater than 2 Life expectancy: * At least 3 months Hematopoietic: * WBC greater than 3,000 (3,000 x 10 to the ninth/L) * Platelet count greater than 120,000 (120 x 10 to the ninth/L) * No bleeding disorder Hepatic: * Bilirubin less than 1.5 times normal * AST and ALT less than 1.5 times normal * Prothrombin or partial thromboplastin time no greater than 2 times normal Renal: * Creatinine less than 1.3 mg/dL (120 micromoles/L) Other: * No ongoing infection * No HIV antibody * No serious medical or psychiatric illness * No second malignancy within 5 years except for curatively treated basal cell skin cancer which required surgery, hormone therapy, immunotherapy or chemotherapy * Not pregnant or nursing * Adequate contraception required * Patient or her household contacts must not have any of the following: * Chronic steroid therapy * Renal or other allograft * Known immunodeficiency * Eczema * Children under 5 years old PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (10)

Innsbruck Universitaetsklinik

Innsbruck, A-6020, Austria

Location

Institut Curie - Section Medicale

Paris, 75248, France

Location

Universitaetsklinikum Freiburg

Freiburg im Breisgau, D-79106, Germany

Location

I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen

Munich, D-80337, Germany

Location

Nijmegen Cancer Center at Radboud University Medical Center

Nijmegen, 6500, Netherlands

Location

Norwegian Radium Hospital

Oslo, N-0310, Norway

Location

University Hospital of Linkoping

Linköping, S-581 85, Sweden

Location

St. Mary's Hospital

Manchester, England, M13 0JH, United Kingdom

Location

Ninewells Hospital and Medical School

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Velindre Cancer Center at Velinde Hospital

Cardiff, Wales, CF14 2TL, United Kingdom

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

oncogene protein E7, Human papillomavirus type 16E6 protein, Human papillomavirus type 16Chemotherapy, AdjuvantSurgical Procedures, OperativeRadiotherapy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Elaine M. Rankin, MD

    Ninewells Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

November 1, 1996

Last Updated

July 2, 2012

Record last verified: 2012-06

Locations

SE(1)NO(1)GB(3)AU(1)DE(2)NL(1)FR(1)