Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cervical Cancer

Intervention / Treatment
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* Biological: human papillomavirus 16 E7 peptide
* Procedure: in vitro-treated peripheral blood stem cell transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: human papillomavirus 16 E7 peptide|nan|
|Procedure: in vitro-treated peripheral blood stem cell transplantation|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III cervical cancer, recurrent cervical cancer, stage IB cervical cancer, stage IIB cervical cancer, stage IVB cervical cancer, stage IA cervical cancer, stage IIA cervical cancer, stage IVA cervical cancer