- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00006025
Temozolomide Plus Irinotecan in Treating Patients With Recurrent Malignant Glioma
Phase I-II Trial of CPT-11 and Temozolomide (Temodar) in Patients With Recurrent Malignant Glioma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of temozolomide plus irinotecan in treating patients who have recurrent malignant glioma.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Determine the maximum tolerated dose and dose-limiting toxicity of irinotecan when administered with temozolomide in patients with recurrent malignant glioma.
- Determine the safety profile of this regimen in this patient population.
- Determine the efficacy of this treatment regimen as measured by 6-month progression-free survival and objective tumor response in these patients.
- Characterize the pharmacokinetics of this treatment regimen in these patients.
- Determine the antitumor activity of this treatment regimen in these patients.
OUTLINE: This is a multicenter, dose-escalation study of irinotecan. Patients are stratified according to concurrent enzyme-inducing anti-epileptic drugs (EIAEDs) (e.g., phenytoin, phenobarbital, carbamazepine, or primidone) (yes vs no).
In phase I of the study, patients receive oral temozolomide on days 1-5 and irinotecan IV over 90 minutes on days 1 and 14. Treatment continues every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients concurrently on EIAEDs undergo dose escalation of irinotecan. Cohorts of 3 to 6 patients receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 6 patients experience dose-limiting toxicity.
In phase II of the study, patients receive the same treatment as in phase I at the MTD.
Patients are followed every 2 months for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months until progression, and then every 4 months for survival.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for phase I within 10 months and 48 patients will be accrued for phase II within 6-8 months.
Tipo de estudio
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90095
- Jonsson Comprehensive Cancer Center, UCLA
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San Francisco, California, Estados Unidos, 94143
- UCSF Comprehensive Cancer Center
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Maryland
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Bethesda, Maryland, Estados Unidos, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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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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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15232
- Hillman Cancer Center at University of Pittsburgh Cancer Institute
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Texas
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Houston, Texas, Estados Unidos, 77030-4009
- University of Texas - MD Anderson Cancer Center
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San Antonio, Texas, Estados Unidos, 78284-6220
- University of Texas Health Science Center at San Antonio
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- University of Wisconsin Comprehensive 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 supratentorial malignant primary glioma of one of the following subtypes:
- Glioblastoma multiforme
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Mixed malignant glioma
- Original histology of low-grade glioma allowed if subsequent histological confirmation of malignant glioma
Measurable recurrent or residual primary disease by MRI
- Lesions with clearly defined margins
- Evidence of tumor recurrence or progression by MRI or CT scan
- Confirmation of true progressive disease by PET or thallium scan, magnetic resonance spectroscopy, or surgical documentation after prior interstitial brachytherapy or stereotactic radiosurgery
- No more than 3 relapses after prior chemotherapy/cytotoxic therapy (including polifeprosan 20 with carmustine implant) for phase I and no more than 2 relapses for phase II
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,000/mm^3
- Absolute neutrophil count 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 1.5 mg/dL
- SGOT no greater than 2 times upper limit of normal
Renal:
- Creatinine no greater than 1.5 mg/dL
Cardiovascular:
- No uncontrolled hypertension, unstable angina, or symptomatic congestive heart failure
- No myocardial infarction within the past 6 months
- No serious uncontrolled cardiac arrhythmia
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No mental incapacitation
- HIV negative
- No AIDS-related disease
- No significant ongoing alcoholism or substance abuse
- No severe nonmalignant systemic disease
- No active infection
- No other severe disease that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- At least 1 week since prior interferon or thalidomide and recovered
- No concurrent anticancer immunotherapy
- No concurrent sargramostim (GM-CSF)
- No concurrent prophylactic filgrastim (G-CSF) during first course of study therapy
Chemotherapy:
- See Disease Characteristics
- Recovered from prior chemotherapy
- At least 2 weeks since prior vincristine
- At least 3 weeks since prior procarbazine
- At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosourea)
- Prior radiosensitizers allowed
- No prior temozolomide or irinotecan
- No other concurrent anticancer chemotherapy
Endocrine therapy:
- At least 1 week since prior tamoxifen and recovered
- No concurrent anticancer hormonal therapy
Phase II:
- Non-increasing dose of corticosteroids allowed
Radiotherapy:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy and recovered
- No concurrent anticancer radiotherapy
Surgery:
- See Disease Characteristics
- At least 1-3 weeks since prior surgical resection and recovered
Other:
- At least 1 week since prior noncytotoxic agents (e.g., isotretinoin) and recovered
- Concurrent enzyme-inducing anti-epileptic drugs with or without steroids allowed
- No concurrent valproic acid as a single agent
- No concurrent medication that would preclude study (e.g., nonsteroidal immunosuppressive agents)
- No other concurrent investigational drugs
- No concurrent participation in other clinical study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
Colaboradores e Investigadores
Colaboradores
Investigadores
- Silla de estudio: Wai-Kwan A. Yung, MD, M.D. Anderson Cancer Center
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
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
- Enfermedades del Sistema Nervioso
- Neoplasias por tipo histológico
- Neoplasias
- Neoplasias por sitio
- Neoplasias Glandulares y Epiteliales
- Neoplasias Neuroepiteliales
- Tumores neuroectodérmicos
- Neoplasias De Células Germinales Y Embrionarias
- Neoplasias De Tejido Nervioso
- Glioma
- Neoplasias del Sistema Nervioso
- Neoplasias del Sistema Nervioso Central
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Agentes antineoplásicos
- Agentes antineoplásicos, alquilantes
- Agentes alquilantes
- Inhibidores de la topoisomerasa
- Inhibidores de la topoisomerasa I
- Temozolomida
- Irinotecán
Otros números de identificación del estudio
- NABTC-9907
- CDR0000068037 (Identificador de registro: PDQ (Physician Data Query))
- UCLA-0006095
- NCI-2012-02353 (Identificador de registro: CTRP (Clinical Trials Reporting System))
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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