AzTrials
AzTrials

Cervical CancerPhase 2NCT00075569

SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia

A Phase 2 study testing HspE7 in people with Cervical Cancer and Precancerous Condition, run by Albert Einstein College of Medicine at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years, women only
Conditions the study is for
Cervical Cancer, Precancerous Condition
What is being tested?
HspE7
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
2 sitesUnited States
Study dates
Mar 2004to Aug 2005
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • New York Weill Cornell Cancer Center at Cornell University

    New York, New York, 10021

  • Albert Einstein Cancer Center at Albert Einstein College of Medicine

    The Bronx, New York, 10461

Other trials in United States

About this study

Official title: SGN-00101 (HspE7) Immunotherapy Of CIN III

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.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the rate of regression at 4-7 months in patients with grade III cervical intraepithelial neoplasia (CIN III) treated with SGN-00101 immunotherapy.
  • Compare the rate of regression at 4-7 months with expected outcome in patients immunized with this vaccine.
  • Determine the toxic effects and recovery from possible toxic effects of this vaccine in these patients.

Secondary

  • Determine induction of cell-mediated immune responses against human papillomavirus (HPV) E7 peptides before and after treatment in patients immunized with this vaccine
  • Correlate regression of disease with enhanced immunologic responses in patients immunized with this vaccine.
  • Correlate seropositivity of HPV-16 virus-like particles (VLP16) with vaccine-induced regression of CIN III in patients immunized with this vaccine.
  • Determine the efficacy of this vaccine in patients whose CIN III is associated with HPV-16 infection vs other HPV types.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment groups.

All patients receive SGN-00101 subcutaneously once monthly on months 1-3 (for a total of 3 vaccinations) in the absence of disease progression or unacceptable toxicity.

  • Group 1: Four months after the first vaccination, patients undergo therapeutic and diagnostic loop electrosurgical excision procedure (LEEP) or core biopsy.
  • Group 2: Six months after the first vaccination, patients undergo therapeutic and diagnostic LEEP or core biopsy.

Patients in group 1 are followed at 12 months and patients in group 2 are followed at 14 months after the first vaccination.

PROJECTED ACCRUAL: A total of 66 patients (36 for group 1 and 30 for group 2) will be accrued for this study.

Being tested
HspE7
Keywords
cervical cancer, cervical intraepithelial neoplasia grade 3
Medical subject headings
Uterine Cervical Neoplasms, Precancerous Conditions, Uterine Cervical Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HspE7Biological

    Also called SGN-00101

    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.

Study groups in NCT00075569
Study groupRoleWhat they receive
1 month follow-upActive comparator3 monthly subcutaneous vaccinations with 500 microg of HspE7 followed by monthly colposcopic follow-up for 1 month; followed by LEEP or cone biopsy
Receives: Biological: HspE7
2 month follow-upActive comparator3 monthly subcutaneous vaccinations with 500 microg of HspE7 followed by monthly colposcopic follow-up for 2 months; followed by LEEP or cone biopsy
Receives: Biological: HspE7

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of regression

    Measured: 4 months after completion of treatment

  2. Toxicity

    Measured: 4 months after completion of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2004 (estimated)
  2. Study startMar 2004
  3. Primary completionAug 2005
  4. Study completionAug 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Parallel design
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00075569
Sponsor's protocol ID
03-10-251
Other IDs
AECOM-0309225, NCI-5850
Status last verified
Jan 2006
First submitted
9 Jan 2004
Last updated
21 May 2018
Results posted
No

Publications

  • 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.

    PubMed 17586030

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HspE7 in people with Cervical Cancer and Precancerous Condition, run by Albert Einstein College of Medicine at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of regression (time frame: 4 months after completion of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00075569, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in