500 Boylston Street, Boston, MA 02116 617-419-4700
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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
Ages:18 and older
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
Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Phase: Phase 1
Trial ID: NCT00003977
Not Accepting Healthy Volunteers