Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer
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ClinicalTrials.gov Identifier: NCT00003977 |
Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : February 9, 2009
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cervical Cancer | Biological: human papillomavirus 16 E7 peptide Procedure: in vitro-treated peripheral blood stem cell transplantation | Phase 1 |
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 (Clinical Trial) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | November 1999 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003977
United States, Massachusetts | |
St. Elizabeth's Medical Center | |
Boston, Massachusetts, United States, 02135-2997 |
Study Chair: | Michael A. Steller, MD | Steward St. Elizabeth's Medical Center of Boston, Inc. |
ClinicalTrials.gov Identifier: | NCT00003977 |
Other Study ID Numbers: |
CDR0000067180 SEMC-980016 NCI-T98-0072 |
First Posted: | January 27, 2003 Key Record Dates |
Last Update Posted: | February 9, 2009 |
Last Verified: | December 2003 |
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 |
Uterine Cervical Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Neoplasms Uterine Cervical Diseases Uterine Diseases |