- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00058435
Monoclonal Antibody Vaccine Therapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
Phase I Trial of the Monoclonal Anti-Idiotype Antibody ACA125 in Patients With Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
RATIONALE: Vaccines made from monoclonal antibodies combined with tumor cells may make the body build an immune response to kill tumor cells.
PURPOSE: Randomized phase I trial to study the effectiveness of vaccine therapy in treating patients who have ovarian epithelial, fallopian tube, or peritoneal cancer.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Determine the safety of varying routes and doses of monoclonal antibody ACA125 anti-idiotype vaccine in patients with ovarian epithelial, fallopian tube, or peritoneal cancer.
- Determine an optimal dose and route of this vaccine for a phase II study.
- Determine the immune response induced by this vaccination in these patients.
- Determine the time to development of objective tumor response in patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 4 treatment arms.
- Arm I: Patients receive lower-dose monoclonal antibody ACA125 anti-idiotype vaccine (MOAB ACA125) intramuscularly (IM) on weeks 0, 2, 4, 6, 10, and 14 in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive higher-dose MOAB ACA125 IM as in arm I.
- Arm III: Patients receive lower-dose MOAB ACA125 subcutaneously (SC) on weeks 0, 2, 4, 6, 10, and 14 in the absence of disease progression or unacceptable toxicity.
- Arm IV: Patients receive higher-dose MOAB ACA125 SC as in arm III. Patients are followed every 6-12 weeks for 2 years.
PROJECTED ACCRUAL: A total of 40 patients (10 patients per cohort) will be accrued for this study.
Tipo de estudio
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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New York, New York, Estados Unidos, 10021
- Memorial Sloan-Kettering Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or peritoneal cancer
- Stage II-IV
- Initially treated with surgery and at least 1 platinum-based chemotherapy regimen
- Must have relapsed after initial treatment and completed chemotherapy for recurrent disease
- Asymptomatic residual measurable disease on CT scan and/or an elevated CA 125 allowed
Complete clinical remission allowed, defined by the following criteria:
- CA 125 no greater than 35 IU/mL
- No objective evidence of disease by CT scan
- Normal physical examination
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 70-100%
Life expectancy
- At least 3 months
Hematopoietic
- WBC at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 10 g/dL
Hepatic
- Bilirubin no greater than 2 times normal
- ALT no greater than 2 times normal
- Alkaline phosphatase no greater than 2 times normal
Renal
- Creatinine no greater than 1.5 times normal
Other
- Not pregnant or nursing
- No potential for child bearing
- Human antimurine antibody negative
- HIV negative
- No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No active infection
- No known autoimmune disease (e.g., rheumatoid arthritis or ulcerative colitis)
- No known immune deficiency (e.g., hypogammaglobulinemia)
- No known allergy to murine proteins
PRIOR CONCURRENT THERAPY:
Biologic therapy
- At least 6 weeks since prior interferon
- At least 6 weeks since prior immunotherapy or biological response modifiers
- No prior anticancer vaccine
Chemotherapy
- See Disease Characteristics
- At least 3 weeks since prior cytotoxic or investigational chemotherapy
Endocrine therapy
- No concurrent steroids
Radiotherapy
- At least 4 weeks since prior radiotherapy
Surgery
- See Disease Characteristics
Other
- At least 1 week since prior antibiotics
- No concurrent cyclosporine
- No other concurrent immunosuppressive therapy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Enmascaramiento: Ninguno (etiqueta abierta)
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 02-122
- CDR0000288831 (Identificador de registro: PDQ (Physician Data Query))
- CELLCONTROL-MSKCC-02122
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