Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

A Phase I Study of Immunization With Alternating Human Papillomavirus E7 Lipopeptide Epitope Vaccine and Dendritic Cells Presenting the E7 Epitope for the Treatment of Recurrent or Persistent Cervical Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003977
• Other study ID #: CDR0000067180
• Secondary ID: SEMC-980016NCI-T
• Status: Completed
• Phase: Phase 1
• First received: November 1, 1999
• Last updated: February 6, 2009
• Start date: November 1999

Study information

• Verified date: December 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients with recurrent or persistent cervical cancer that cannot be treated with surgery or radiation therapy.

Description:

OBJECTIVES:

• Evaluate alternating vaccination with lipidated human papillomavirus 16 E7 peptide (HPV-16 E7) and autologous dendritic cells pulsed with immunogenic HPV-16 E7 in terms of toxicity, immunologic reactivity, and therapeutic efficacy in patients with recurrent or persistent cervical cancer.

OUTLINE: This is a dose-escalation study of dendritic cell-human papillomavirus 16 E7 (HPV-16 E7) peptide vaccine.

Patients undergo leukapheresis to obtain peripheral blood mononuclear cells for activation to dendritic cells on days 0 and 28. Patients receive lipidated HPV-16 E7 peptide vaccine subcutaneously on days 1 and 14 and dendritic cell-HPV-16 E7 peptide vaccine IV over 15-30 minutes on days 7 and 21. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with stable disease or complete or partial response may receive one additional treatment course, beginning 6 weeks after the end of the first course.

Cohorts of 3-9 patients receive escalating doses of dendritic cell-HPV-16 E7 peptide vaccine. The maximum tolerated dose is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity.

A parallel cohort of patients receives dendritic cell-HPV-16 E7 peptide vaccine IV over 15-30 minutes on days 7 and 14, but does not receive lipidated HPV-16 E7 peptide.

Patients are followed at one week.

PROJECTED ACCRUAL: Approximately 27 patients will be accrued for this study at a rate of 15 patients per year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically proven recurrent or persistent cervical cancer not amenable to surgery or radiotherapy

• Measurable and evaluable disease

• HLA-A2 positive

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• More than 3 months

Hematopoietic:

• WBC greater than 3,000/mm^3

• Platelet count greater than 100,000/mm^3

• Hemoglobin greater than 8.0 g/dL

• No coagulation disorders

Hepatic:

• Bilirubin less than 2.0 mg/dL

• SGOT less than 4 times upper limit of normal

Renal:

• Creatinine less than 1.5 mg/dL OR

• Creatinine clearance greater than 75 mL/min

Cardiovascular:

• No major cardiovascular illness

Pulmonary:

• No major pulmonary illness

Other:

• HIV negative

• Hepatitis B surface antigen negative

• No active systemic infection

• Not pregnant

• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least one month since prior biologic therapy

Chemotherapy:

• At least one month since prior chemotherapy

Endocrine therapy:

• At least one month since prior endocrine therapy

• No concurrent steroid therapy

Radiotherapy:

• See Disease Characteristics

• At least one month since prior radiotherapy

Surgery:

• See Disease Characteristics

• At least one month since prior surgery

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Biological:
• human papillomavirus 16 E7 peptide

Procedure:
• in vitro-treated peripheral blood stem cell transplantation

Locations

Country	Name	City	State
United States	St. Elizabeth's Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Steward St. Elizabeth's Medical Center of Boston, Inc.	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,