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Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003977
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : February 9, 2009
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

Study Description
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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
Cervical Cancer Biological: human papillomavirus 16 E7 peptide Procedure: in vitro-treated peripheral blood stem cell transplantation 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
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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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

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


Locations
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United States, Massachusetts
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
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Study Chair: Michael A. Steller, MD Steward St. Elizabeth's Medical Center of Boston, Inc.
More Information
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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
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
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases