Clinical Trial: Vaccine Therapy in Treating Patients With Recurrent or Persistent Cervical Cancer

This study has been suspended.

Sponsors and Collaborators: Women and Infants Hospital of Rhode Island
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
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
 Drug: human papillomavirus 16 E7 peptide
 Procedure: biological response modifier therapy
 Procedure: bone marrow ablation with stem cell support
 Procedure: in vitro-treated peripheral blood stem cell transplantation
 Procedure: non-tumor cell derivative vaccine
 Procedure: recombinant viral vaccine
 Procedure: vaccine therapy
Phase I

MedlinePlus related topics:  Cervical Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of Immunization With Alternating Lipidated Human Papillomavirus 16 E7 (HPV-16 E7) Peptide Vaccine and Dendritic Cell-HPV-16 E7 Peptide Vaccine in Patients With Recurrent or Persistent Cervical Cancer

Further Study Details: 

OBJECTIVES:

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 above,  Genders Eligible for Study:  Both

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:

  • Greater than 3 months

Hematopoietic:

  • WBC greater than 3,000/mm3
  • Platelet count greater than 100,000/mm3
  • 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:

Pulmonary:

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

Location Information


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

Study chairs or principal investigators

Michael A. Steller, MD,  Study Chair,  St. Elizabeth's Medical Center   

More Information

Study ID Numbers:  CDR0000067180; WIHRI-980016; NCI-T98-0072
Record last reviewed:  March 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003977
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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