Clinical trial NCT00075569: SGN-00101 Immunotherapy in Treating Patients With Grade III Cervical Intraepithelial Neoplasia
Official title: SGN-00101 (HspE7) Immunotherapy Of CIN III
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cervical Cancer
Precancerous Condition
Keywords: cervical cancer
cervical intraepithelial neoplasia grade 3
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-01-12
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel design
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Rate of regression
timeFrame: 4 months after completion of treatment
measure: Toxicity
timeFrame: 4 months after completion of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein Cancer Center at Albert Einstein College of Medicine
state: New York
city: New York
country: United States
facility: New York Weill Cornell Cancer Center at Cornell University
state: New York
Study officials:
affiliation: UConn Health
name: Carolyn D. Runowicz, MD
role: STUDY_CHAIR
affiliation: Albert Einstein College of Medicine
name: Mark H. Einstein, MD, MS
References:
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.