NCT00003977

Brief Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients with recurrent or persistent cervical cancer that cannot be treated with surgery or radiation therapy.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 1, 1999

Completed
Same day until next milestone

Study Start

First participant enrolled

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

February 9, 2009

Status Verified

December 1, 2003

First QC Date

November 1, 1999

Last Update Submit

February 6, 2009

Conditions

Cervical Cancer

Keywords

stage III cervical cancerrecurrent cervical cancerstage IB cervical cancerstage IIB cervical cancerstage IVB cervical cancerstage IA cervical cancerstage IIA cervical cancerstage IVA cervical cancer

Interventions

human papillomavirus 16 E7 peptideBIOLOGICAL
in vitro-treated peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically proven recurrent or persistent cervical cancer not amenable to surgery or radiotherapy * Measurable and evaluable disease * HLA-A2 positive PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * WBC greater than 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 8.0 g/dL * No coagulation disorders Hepatic: * Bilirubin less than 2.0 mg/dL * SGOT less than 4 times upper limit of normal Renal: * Creatinine less than 1.5 mg/dL OR * Creatinine clearance greater than 75 mL/min Cardiovascular: * No major cardiovascular illness Pulmonary: * No major pulmonary illness Other: * HIV negative * Hepatitis B surface antigen negative * No active systemic infection * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least one month since prior biologic therapy Chemotherapy: * At least one month since prior chemotherapy Endocrine therapy: * At least one month since prior endocrine therapy * No concurrent steroid therapy Radiotherapy: * See Disease Characteristics * At least one month since prior radiotherapy Surgery: * See Disease Characteristics * At least one month since prior surgery

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

Sponsors & Collaborators

Study Sites (1)

St. Elizabeth's Medical Center

Boston, Massachusetts, 02135-2997, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

oncogene protein E7, Human papillomavirus type 16

Condition Hierarchy (Ancestors)

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

Study Officials

  • Michael A. Steller, MD

    Steward St. Elizabeth's Medical Center of Boston, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

November 1, 1999

Last Updated

February 9, 2009

Record last verified: 2003-12

Locations

US(1)