Surgery and Vaccine Therapy in Treating Patients With Early Cervical Cancer
A Phase II Trial in Patients With Early Cervical Cancer to Study The Safety and The Immunological Effects of Vaccination With TA-HPV, A Live Recombinant Vaccinia Virus Expressing The Human Papilloma Virus 16 and 18 E6 and E7 Proteins
RATIONALE: Vaccines made from human papillomavirus may make the body build an immune response to and kill cervical cancer cells. Combining vaccine therapy with surgery may be a more effective treatment for cervical cancer.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with surgery works in treating patients with early cervical cancer.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
OBJECTIVES:
- Evaluate the systemic immunological response to the human papilloma virus vaccine (TA-HPV) expressing the proteins 16, 18, E6 and E7 examining the cytolytic T cell and the antibody responses in cervical cancer patients.
- Investigate further the safety and toxic effects of TA-HPV in these patients.
- Assess the proliferative capacity of T cells to the E6 and E7 proteins.
- Observe any influence of vaccination with TA-HPV on the disease free interval or patterns of recurrence in these patients.
OUTLINE: This is an open-label, nonrandomized study.
Patients receive 2 vaccinations of the human papilloma virus with proteins 16, 18, E6 and E7 at least 4 weeks apart, with the first vaccination at least 2 weeks before surgery and the second 8 weeks after the first one, unless unacceptable toxicity occurs. Patients who require radiotherapy following surgery receive their second vaccination 4-8 weeks after the first vaccination.
Twenty-eight patients are entered initially; if at least 2 patients show an immunologic response, 16 additional patients are entered.
Patients are followed every 3 months for 2 years, then every 6 months for 3 years, then annually.
PROJECTED ACCRUAL: 44 patients will be entered over 1 year.
Studietype
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Paris, Frankrike, 75248
- Institut Curie - Section Medicale
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Nijmegen, Nederland, 6500
- Nijmegen Cancer Center at Radboud University Medical Center
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Oslo, Norge, N-0310
- Norwegian Radium Hospital
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England
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Manchester, England, Storbritannia, M13 0JH
- St. Mary's Hospital
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Scotland
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Dundee, Scotland, Storbritannia, DD1 9SY
- Ninewells Hospital and Medical School
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Wales
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Cardiff, Wales, Storbritannia, CF14 2TL
- Velindre Cancer Center at Velinde Hospital
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Linkoping, Sverige, S-581 85
- University Hospital of Linkoping
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Freiburg, Tyskland, D-79106
- Universitaetsklinikum Freiburg
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Munich, Tyskland, D-80337
- I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen
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Innsbruck, Østerrike, A-6020
- Innsbruck Universitaetsklinik
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically proven untreated stage Ib or IIa cervical carcinoma, squamous or adenocarcinoma suitable for surgical excision
- No CNS metastases
- Circulating CD4+ lymphocyte count at least 400
- Proven absence of hepatitis B and C antibodies
- Previous exposure to vaccinia from smallpox vaccination, as well as no previous exposure, is allowed
- Reaction to 2 or more antigens on Pasteur Merieux CMI test required
- Ability to collaborate planned follow-up required
PATIENT CHARACTERISTICS:
Age:
- 19 and over
Performance status:
- WHO/ECOG no greater than 2
Life expectancy:
- At least 3 months
Hematopoietic:
- WBC greater than 3,000 (3,000 x 10 to the ninth/L)
- Platelet count greater than 120,000 (120 x 10 to the ninth/L)
- No bleeding disorder
Hepatic:
- Bilirubin less than 1.5 times normal
- AST and ALT less than 1.5 times normal
- Prothrombin or partial thromboplastin time no greater than 2 times normal
Renal:
- Creatinine less than 1.3 mg/dL (120 micromoles/L)
Other:
- No ongoing infection
- No HIV antibody
- No serious medical or psychiatric illness
- No second malignancy within 5 years except for curatively treated basal cell skin cancer which required surgery, hormone therapy, immunotherapy or chemotherapy
- Not pregnant or nursing
- Adequate contraception required
Patient or her household contacts must not have any of the following:
- Chronic steroid therapy
- Renal or other allograft
- Known immunodeficiency
- Eczema
- Children under 5 years old
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- Not specified
Endocrine therapy:
- Not specified
Radiotherapy:
- Not specified
Surgery:
- Not specified
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
Hva måler studien?
Primære resultatmål
Resultatmål |
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Immunological response to HPV
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Toxicity and safety of TA-HPV
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Sekundære resultatmål
Resultatmål |
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Proliferative capacity of T-cells to the E6 and E7 proteins
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Influence of vaccination with TA-HPV on the disease free interval or patterns of recurrence
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Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Elaine M. Rankin, MD, Ninewells Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EORTC-13961
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