Completado

Evaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian or Primary Peritoneal Cancer

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

Colección de datos

Quiénes están siendo reclutados

Carcinoma+15

+ Enfermedades Urogenitales

+ Enfermedades Anexiales

A partir de 18 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Fase 1
Intervencional
Inicio del estudio: junio de 2004
Ver detalles del protocolo

Resumen

Patrocinador PrincipalUniversity of Virginia
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 1 de junio de 2004

Fecha en la que se inscribió al primer participante.

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.

Título OficialEvaluation of Safety and Immunogenicity of a Peptide Vaccine in Patients With Epithelial Ovarian or Primary Peritoneal Cancer
NCT00091273
Patrocinador PrincipalUniversity of Virginia
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 9 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.


Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Mujer

Sexo biológico de los participantes elegibles para inscribirse.

A partir de 18 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

CarcinomaEnfermedades UrogenitalesEnfermedades AnexialesEnfermedades del Sistema EndocrinoNeoplasias de Glándulas EndocrinasCarcinoma de ovario epitelialEnfermedades GenitalesEnfermedades Genitales FemeninasTrastornos GonadalesEnfermedades Urogenitales Femeninas y Complicaciones del EmbarazoNeoplasias Genitales FemeninasNeoplasiasNeoplasias por SitioNeoplasias por tipo histológicoNeoplasias glandulares y epitelialesEnfermedades del OvarioNeoplasias OváricoNeoplasias Urogenitales

Criterios

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 Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Objetivos del Estudio

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Suspendido

University of Virginia Cancer Center

Charlottesville, United StatesAbrir University of Virginia Cancer Center en Google Maps
Completado1 Centros de Estudio