Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer

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

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Cervical Cancer

Interventions

human papillomavirus 16 E7 peptideBIOLOGICAL

in vitro-treated peripheral blood stem cell transplantationPROCEDURE

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

St. Elizabeth's Medical Center

Boston, Massachusetts, United States

Data from ClinicalTrials.gov

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