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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


Phase 1
18 Years
N/A
Not Enrolling
Female
Cervical Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Michael A. Steller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Steward St. Elizabeth's Medical Center of Boston, Inc.

Authority:

United States: Federal Government

Study ID:

CDR0000067180

NCT ID:

NCT00003977

Start Date:

November 1999

Completion Date:

Related Keywords:

  • Cervical Cancer
  • 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
  • Uterine Cervical Neoplasms

Name

Location

St. Elizabeth's Medical CenterBoston, Massachusetts  02135-2997