Clinical trial NCT00003977: Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cervical Cancer
Keywords: 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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
Study officials:
affiliation: Steward St. Elizabeth's Medical Center of Boston, Inc.
name: Michael A. Steller, MD
role: STUDY_CHAIR
References: