Expired Study
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Boston, Massachusetts 02135


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00003977


Primary Contact:

Study Chair
Michael A. Steller, MD
Steward St. Elizabeth's Medical Center of Boston, Inc.


Backup Contact:

N/A


Location Contact:

Boston, Massachusetts 02135
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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