Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer

NCT ID: NCT00003977

Last Updated: 2009-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-11-30

Brief 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.

Detailed 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.

Conditions

Cervical Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

human papillomavirus 16 E7 peptide

Intervention Type: BIOLOGICAL

in vitro-treated peripheral blood stem cell transplantation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Steward St. Elizabeth's Medical Center of Boston, Inc.

OTHER

Sponsor Role: lead

Principal Investigators

Michael A. Steller, MD

Role: STUDY_CHAIR

Steward St. Elizabeth's Medical Center of Boston, Inc.

Locations

St. Elizabeth's Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

SEMC-980016

Identifier Type: -

Identifier Source: secondary_id

NCI-T98-0072

Identifier Type: -

Identifier Source: secondary_id

CDR0000067180

Identifier Type: -

Identifier Source: org_study_id