Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer - Full Text View

Sponsor:	Caritas St. Elizabeth's Medical Center of Boston
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003977

Purpose

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	Intervention	Phase
Cervical Cancer	Biological: human papillomavirus 16 E7 peptide Procedure: in vitro-treated peripheral blood stem cell transplantation	Phase I

Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

November 1999

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003977

Locations

United States, Massachusetts
St. Elizabeth's Medical Center
Boston, Massachusetts, United States, 02135-2997

Sponsors and Collaborators

Caritas St. Elizabeth's Medical Center of Boston

National Cancer Institute (NCI)

Investigators

Study Chair:

Michael A. Steller, MD

Caritas St. Elizabeth's Medical Center of Boston

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067180, SEMC-980016, NCI-T98-0072
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003977 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

ClinicalTrials.gov processed this record on November 27, 2009