Gene Therapy in Treating Patients With Recurrent Head and Neck Cancer
A Phase II, Multicenter, Open Label Study to Evaluate Effectiveness and Safety of AdCMV-p53 Administered by Intra-Tumoral Injections in 39 Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
RATIONALE: Inserting the gene for p53 into a person's tumor may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of gene therapy in treating patients who have recurrent head and neck cancer.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES: I. Estimate the objective response rate of Ad5CMV-p53 in patients with recurrent squamous cell carcinoma of the head and neck. II. Evaluate the duration of response, time to disease progression, and overall survival of these patients after this treatment. III. Evaluate the effectiveness of Ad5CMV-p53 in reducing cancer morbidity (pain assessment, analgesic consumption, and Karnofsky performance status). IV. Assess the quality of life of these patients receiving this treatment.
OUTLINE: This is a multicenter, open label study. All patients receive direct intratumoral injections of Ad5CMV-p53 on days 1, 2, and 3 of each 4-week treatment course. Patients are treated for at least 2 courses barring local disease progression or unacceptable adverse events; patients with responding or stable disease receive a maximum of 12 courses. Patients are evaluated for safety 4 weeks from the completion of the last treatment. Quality of life is assessed before, during, and after treatment. Patients are followed every 2 months for up to 18 months or until death.
PROJECTED ACCRUAL: A maximum of 39 patients will be accrued for this study.
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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San Diego, California, Estados Unidos, 92121
- Sidney Kimmel Cancer Center
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Colorado
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Denver, Colorado, Estados Unidos, 80262
- University of Colorado Cancer Center
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Connecticut
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Farmington, Connecticut, Estados Unidos, 06032
- University of Connecticut School of Medicine
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Illinois
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Chicago, Illinois, Estados Unidos, 60612
- Clinical Sciences Building
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Iowa
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Iowa City, Iowa, Estados Unidos, 52242
- University of Iowa Hospitals and Clinics
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Kansas
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Kansas City, Kansas, Estados Unidos, 66160-7357
- University of Kansas Medical Center
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 70112
- Tulane University School of Medicine
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Maryland
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Baltimore, Maryland, Estados Unidos, 21201
- Marlene & Stewart Greenebaum Cancer Center, University of Maryland
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New York
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Bronx, New York, Estados Unidos, 10461
- Albert Einstein Comprehensive Cancer Center
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Texas
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Dallas, Texas, Estados Unidos, 75235-9154
- Simmons Cancer Center - Dallas
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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 proven squamous cell carcinoma of the head and neck (SCCHN) Recurrent disease documented by histology or cytology (excluding endolaryngeal recurrence) following first line therapy with curative intent, such as: Radiation (at least 5000 cGy by standard methodology) and/or Surgery (definitive resection with postoperative radiation as indicated) Lesions accessible to intratumoral injections Bidimensionally measurable disease The sum of the products of the bidirectional measurements for all bidimensionally measurable lesions must be not greater than 30 cm2 The sum of the longest diameters of all measurable lesions must be not greater than 10 cm No CNS metastasis Tumor tissue from biopsy of primary or recurrent tumor must be available to determine p53 mutation status
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Greater than 12 weeks Hematopoietic: Platelet count at least 100,000/mm3 Absolute neutrophil count at least 2,000/mm3 Hepatic: Total bilirubin no greater than upper limit of normal (ULN) AST/SGOT and/or ALT/SGPT no greater than 1.5 times ULN Alkaline phosphatase no greater than 5 times ULN Renal: Not specified Other: Not pregnant or nursing Barrier contraception required during treatment Negative for HIV 1, HIV 2, hepatitis B, and hepatitis C At least 2 years since prior malignancy, other than SCCHN No contact with former tissue or organ transplant recipients or persons with severe immunodeficiency disease within 28 days following final dose of study drug No serious concurrent medical conditions No active uncontrolled infection
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunostimulating drugs No prior autologous or allogeneic organ or tissue transplant Chemotherapy: At least 4 weeks since prior chemotherapy At least 6 weeks since nitrosourea or mitomycin No other concurrent chemotherapy Endocrine therapy: No concurrent nontopical corticosteroids unless chronic (at least 6 months) at low doses (no greater than 10 mg of oral prednisone) Radiotherapy: See Disease Characteristics At least 4 weeks since radiotherapy to measurable disease sites, unless progressive disease No concurrent radiotherapy to disease sites receiving study drug injections Surgery: See Disease Characteristics No concurrent surgery to disease sites receiving study drug injections Other: No concurrent high dose steroids At least 4 weeks since experimental therapy No concurrent other experimental drugs or therapy No prior gene therapy using adenoviral vectors
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Lyndah Dreiling, MD, Aventis Pharmaceuticals
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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
- Cáncer de cuello escamoso metastásico recurrente con tumor primario oculto
- Carcinoma recurrente de células escamosas de labio y cavidad oral.
- carcinoma de células escamosas recurrente de la orofaringe
- carcinoma de células escamosas recurrente de la nasofaringe
- carcinoma de células escamosas recurrente de hipofaringe
- carcinoma de células escamosas recurrente de laringe
- Carcinoma de células escamosas recurrente del seno paranasal y la cavidad nasal
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CDR0000066148
- AVENTIS-T-202
- MCC-11653
- RP-T-202
- NCI-V98-1394
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