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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

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Trial Conditions
  • Cervical Cancer
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Female

Eligibility

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

Gender: Female
Steward Physician(s)
  • Michael A. Steller, MD
Trial Interventions
Biological
  • human papillomavirus 16 E7 peptide
Procedure
  • in vitro-treated peripheral blood stem cell transplantation
Physician Researcher

Investigator Name:

  • Michael A. Steller, MD

Other Information

Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Phase: Phase 1
Trial ID: NCT00003977
Volunteers:  Not Accepting Healthy Volunteers

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