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

Primary Purpose

Cervical Cancer, Precancerous Condition

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HspE7
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer focused on measuring cervical cancer, cervical intraepithelial neoplasia grade 3

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Albert Einstein Cancer Center at Albert Einstein College of Medicine
  • New York Weill Cornell Cancer Center at Cornell University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1 month follow-up

2 month follow-up

Arm Description

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

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

Outcomes

Primary Outcome Measures

Rate of regression
Toxicity

Secondary Outcome Measures

Full Information

First Posted
January 9, 2004
Last Updated
May 17, 2018
Sponsor
Albert Einstein College of Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00075569
Brief Title
SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia
Official Title
SGN-00101 (HspE7) Immunotherapy Of CIN III
Study Type
Interventional

2. Study Status

Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
March 2004 (Actual)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Precancerous Condition
Keywords
cervical cancer, cervical intraepithelial neoplasia grade 3

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Parallel design
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 month follow-up
Arm Type
Active Comparator
Arm Description
3 monthly subcutaneous vaccinations with 500 microg of HspE7 followed by monthly colposcopic follow-up for 1 month; followed by LEEP or cone biopsy
Arm Title
2 month follow-up
Arm Type
Active Comparator
Arm Description
3 monthly subcutaneous vaccinations with 500 microg of HspE7 followed by monthly colposcopic follow-up for 2 months; followed by LEEP or cone biopsy
Intervention Type
Biological
Intervention Name(s)
HspE7
Other Intervention Name(s)
SGN-00101
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of regression
Time Frame
4 months after completion of treatment
Title
Toxicity
Time Frame
4 months after completion of treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carolyn D. Runowicz, MD
Organizational Affiliation
UConn Health
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mark H. Einstein, MD, MS
Organizational Affiliation
Albert Einstein College of Medicine
Facility Information:
Facility Name
Albert Einstein Cancer Center at Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
New York Weill Cornell Cancer Center at Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17586030
Citation
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.
Results Reference
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SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia

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