NCT00075569

Brief Summary

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer or to treat early cancer. SGN-00101 may be effective in preventing the development of cervical cancer in patients who have cervical intraepithelial neoplasia. PURPOSE: This phase II trial is studying how well SGN-00101 immunotherapy works in preventing cervical cancer in patients with grade III cervical intraepithelial neoplasia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

January 9, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2004

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

May 21, 2018

Status Verified

January 1, 2006

Enrollment Period

1.4 years

First QC Date

January 9, 2004

Last Update Submit

May 17, 2018

Conditions

Cervical CancerPrecancerous Condition

Keywords

cervical cancercervical intraepithelial neoplasia grade 3

Outcome Measures

Primary Outcomes (2)

  • Rate of regression

    4 months after completion of treatment

  • Toxicity

    4 months after completion of treatment

Study Arms (2)

1 month follow-up

ACTIVE COMPARATOR

3 monthly subcutaneous vaccinations with 500 microg of HspE7 followed by monthly colposcopic follow-up for 1 month; followed by LEEP or cone biopsy

Biological: HspE7

2 month follow-up

ACTIVE COMPARATOR

3 monthly subcutaneous vaccinations with 500 microg of HspE7 followed by monthly colposcopic follow-up for 2 months; followed by LEEP or cone biopsy

Biological: HspE7

Interventions

HspE7BIOLOGICAL

500 micrograms of SGN-00101 (HspE7, Nventa, San Diego, CA) is a novel therapeutic vaccine consisting of a fusion protein containing an M. bovis BCG heat shock protein (Hsp65) covalently linked to the entire sequence of HPV 16 E7.

Also known as: SGN-00101
1 month follow-up2 month follow-up

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed grade III cervical intraepithelial neoplasia (CIN III) with colposcopically visible cervical lesions * No positive endocervical curettage or inadequate colposcopy at the time of initial cervical biopsy PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * WBC at least 3,500/mm\^3 * Lymphocyte count at least 500/mm\^3 * Platelet count at least 150,000/mm\^3 * Hemoglobin at least 10 g/dL * No significant hematologic disease that is uncontrolled with standard therapy Hepatic * Bilirubin no greater than 2 mg/dL * Liver enzymes no greater than 2.5 times normal * No significant hepatic disease that is uncontrolled with standard therapy Renal * Creatinine no greater than 2 mg/dL * No significant renal disease that is uncontrolled with standard therapy Cardiovascular * No significant cardiovascular disease that is uncontrolled with standard therapy Pulmonary * No significant respiratory disease that is uncontrolled with standard therapy * No history of asthma Immunologic * HIV negative * No clinical evidence of immunosuppression * No autoimmune disease * No history of allergic reactions attributed to compounds of similar chemical or biological activity as those used in this study * No history of a positive purified protein derivative (PPD) or Tine test Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Good health based upon the results of a medical history, physical examination, vital signs, and laboratory profile * No uncontrolled chronic disease * Chronic disease requiring medication is allowed provided the patient is not taking immunosuppressive drugs * No significant endocrine (e.g., thyroid or diabetes), neurologic, gastrointestinal, or dermatologic disease that is uncontrolled with standard therapy * No other underlying or unstable disease that would be exacerbated by the study treatment PRIOR CONCURRENT THERAPY: Biologic therapy * No prior BCG vaccination * No other concurrent vaccine therapy Chemotherapy * No concurrent chemotherapy Endocrine therapy * More than 30 days since prior oral or parenteral glucocorticoid steroid Radiotherapy * Not specified Surgery * Not specified Other * More than 30 days since prior participation in another investigational study * No concurrent cytotoxic therapy * No other concurrent investigational agents * No other concurrent investigational or commercial agents or therapies intended to treat CIN

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

Sponsors & Collaborators

Study Sites (2)

New York Weill Cornell Cancer Center at Cornell University

New York, New York, 10021, United States

Location

Albert Einstein Cancer Center at Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Related Publications (1)

  • Einstein MH, Kadish AS, Burk RD, Kim MY, Wadler S, Streicher H, Goldberg GL, Runowicz CD. Heat shock fusion protein-based immunotherapy for treatment of cervical intraepithelial neoplasia III. Gynecol Oncol. 2007 Sep;106(3):453-60. doi: 10.1016/j.ygyno.2007.04.038. Epub 2007 Jun 22.

    PMID: 17586030RESULT

MeSH Terms

Conditions

Uterine Cervical NeoplasmsPrecancerous ConditionsUterine Cervical Dysplasia

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

  • Carolyn D. Runowicz, MD

    UConn Health

    STUDY CHAIR

  • Mark H. Einstein, MD, MS

    Albert Einstein College of Medicine

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2004

First Posted

January 12, 2004

Study Start

March 1, 2004

Primary Completion

August 1, 2005

Study Completion

August 1, 2005

Last Updated

May 21, 2018

Record last verified: 2006-01

Locations

US(2)