Evaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian or Primary Peritoneal Cancer
Collecte de données
Carcinome épithélial ovarien+16
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juin 2004
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: * Determine the safety and immunogenicity of adjuvant vaccine comprising ovarian cancer synthetic peptides, tetanus toxoid helper peptide, and sargramostim (GM-CSF) emulsified in Montanide ISA-51 in patients with previously treated ovarian epithelial or primary peritoneal cancer. OUTLINE: This is an open-label study. Patients receive vaccine comprising ovarian cancer synthetic peptides, tetanus toxoid helper peptide, sargramostim (GM-CSF), and Montanide ISA-51 subcutaneously and intradermally to 2 different sites on days 1, 8, and 15. On day 22, patients undergo removal of the lymph node draining the vaccination site to determine whether the immune system is responding to the vaccine. Patients then receive additional vaccine as above only to the primary vaccination site on days 29, 36, and 43. After completion of study treatment, patients are followed at 1 week, 1 month, every 3 months for 9 months, every 6 months for 1 year, and then annually thereafter. PROJECTED ACCRUAL: A maximum of 9 patients will be accrued for this study.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.9 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial or primary peritoneal cancer * Completed primary therapy (surgery and chemotherapy for newly diagnosed disease) within the past 12 months and meets 1 of the following criteria: * Clinical or radiographic evidence of disease * Serologic evidence of disease * Initial diagnosis of stage III or IV disease AND completed anticancer therapy within the past 12 months * At least 2 intact axillary and/or inguinal lymph node basins * Prior lymph node biopsy allowed provided lymphoscintigraphy demonstrates intact drainage to a node in that basin * HLA-A1-, -A2-, or -A3-positive PATIENT CHARACTERISTICS: Age * 18 and over Performance status * GOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,500/mm\^3 * Hemoglobin \> 8.0 g/dL OR * Hematocrit \> 25% * Platelet count ≥ 80,000/mm\^3 Hepatic * AST and ALT ≤ 2.5 times upper limit of normal * Hepatitis C negative Renal * Not specified Cardiovascular * No New York Heart Association class III or IV heart disease Immunologic * HIV negative * No active infection requiring antibiotics * No prior or active autoimmune disorder requiring cytotoxic or immunosuppressive therapy * No prior autoimmune disorder with visceral involvement * No known or suspected allergy to any component of the study vaccine * The following immunologic conditions are allowed: * Laboratory evidence of autoimmune disease (e.g., positive antinuclear antibody titer) that is asymptomatic * Clinical evidence of vitiligo or other forms of depigmenting illness * Mild arthritis requiring non-steroidal anti-inflammatory drugs Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Weight ≥ 110 lbs * No uncontrolled diabetes, defined as hemoglobin A1C ≥ 7% * No active hyperthyroidism * No current or recent (within the past year) addiction to alcohol or drugs * No medical contraindication or other potential medical problem that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy * More than 2 weeks since prior and no concurrent allergy desensitization injections * More than 2 weeks since prior and no concurrent growth factors (e.g., epoetin alfa or pegfilgrastim) * More than 1 month since prior and no other concurrent immunotherapy * More than 2 weeks since prior and no other concurrent potential immunomodulating agents, including any of the following: * Interferon * Tumor necrosis factor * Interleukins or other cytokines * Biologic response modifiers * Monoclonal antibodies * No prior vaccination with all of the study peptides relevant to the patient's HLA-type Chemotherapy * See Disease Characteristics * More than 1 month since prior chemotherapy and recovered * No concurrent cytotoxic chemotherapy Endocrine therapy * More than 2 weeks since prior and no concurrent parenteral or oral corticosteroids (e.g., prednisone or albuterol) * Topical corticosteroids allowed Radiotherapy * More than 1 month since prior radiotherapy and recovered Surgery * See Disease Characteristics * More than 1 month since prior surgery and recovered Other * More than 1 month since other prior treatment and recovered * More than 1 month since prior and no other concurrent investigational agents
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
University of Virginia Cancer Center
Charlottesville, United StatesOuvrir University of Virginia Cancer Center dans Google Maps