Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Prevention	Completed	18 and over	NCI	AECM-0309225 NCI-5850, NCT00075569, 5850

Objectives

Primary

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

Secondary

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

Entry 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

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

Patient Characteristics:

Age

• 18 and over

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,500/mm³
• Lymphocyte count at least 500/mm³
• Platelet count at least 150,000/mm³
• 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

Expected Enrollment

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

Outcomes

Rate of regression at 4-7 months after completion of treatment
Toxicity

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.

Einstein MH, Kadish AS, Burk RD, et al.: Heat shock fusion protein-based immunotherapy for treatment of cervical intraepithelial neoplasia III. Gynecol Oncol 106 (3): 453-60, 2007.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Albert Einstein Cancer Center at Albert Einstein College of Medicine

Carolyn Runowicz, MD, Protocol chair		Ph: 860-679-2809
Mark Einstein, MD, MS, Protocol co-chair		Ph: 718-405-8082

Registry Information
Official Title		SGN-00101 (HspE7) Immunotherapy Of CIN III
Trial Start Date		2004-03-03
Registered in ClinicalTrials.gov		NCT00075569
Date Submitted to PDQ		2003-11-18
Information Last Verified		2006-01-05
NCI Grant/Contract Number		CM17103

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