Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer
Study Details
Study Description
Brief Summary
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 |
|---|---|---|
|
Phase 1 |
Detailed Description
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 Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Elizabeth's Medical Center | Boston | Massachusetts | United States | 02135-2997 |
Sponsors and Collaborators
- Steward St. Elizabeth's Medical Center of Boston, Inc.
- National Cancer Institute (NCI)
Investigators
- Study Chair: Michael A. Steller, MD, Steward St. Elizabeth's Medical Center of Boston, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000067180
- SEMC-980016
- NCI-T98-0072