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
human papillomavirus 16 E7 peptide
+ in vitro-treated peripheral blood stem cell transplantation
Urogenital Diseases+10
+ Genital Diseases
+ Uterine Cervical Diseases
Treatment Study
Summary
Study start date: November 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
St. Elizabeth's Medical Center
Boston, United StatesOpen St. Elizabeth's Medical Center in Google Maps