- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00361088
A Combination of Zarnestra With Velcade for Patients With Relapsed Multiple Myeloma
A Dose Escalation of Zarnestra (R115777) Combined With Velcade® (PS-341) in Patients With Relapsed Multiple Myeloma
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
In Phase I, patients will receive intravenous PS-341 (Velcade) and 3 different dose levels of oral R115777 (Zarnestra). Dose Limiting Toxicity (DLT) will be determined over a period of one cycle and dose escalation to the next level will not occur until all patients projected at each level complete one cycle of therapy. Once DLT is determined, patients in Phase I and all patients enrolled for the phase II component will be treated at the maximum tolerated dose (MTD) to complete 8 cycles of therapy. Treatment will continue beyond 8 cycles if there is evidence of continued response. The study regimen will consist of two weeks of treatment followed by one week off for a total cycle duration of three weeks. If disease stabilization occurs (noted on 2 consecutive cycles) after the standard 8 cycles are given, treatment will be discontinued.
Patients are to be monitored for adverse events throughout the treatment phases and for a minimum of 30 days after their last dose of drugs. Follow up will include history and physical exam with laboratory evaluation at least every 3 months. Laboratories will include CMP, CBC, SPEP, UPEP, and quantitative immunoglobulins. A skeletal survey will be performed at least every 6 months.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Tampa, Florida, Estados Unidos, 33612
- H. Lee Moffitt Cancer Center & Research Institute
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Voluntary written informed consent
- Female subject is either post-menopausal/surgically sterilized or willing to use an acceptable method of birth control for the duration of the study.
- Male subject agrees to use an acceptable method for contraception for the duration of the study.
Diagnosis of stage II or III multiple myeloma and have relapsed after at least one prior therapies confirmed by the presence of:
- A new lytic lesion
- A 25% increase in urine or serum monoclonal protein
- Patient can have received PS-341 (Velcade) previously and does not require a previous response.
Patients must have measurable disease. One or more of the following must be present to qualify for this study:
- Serum M-component greater than or equal to 1.0 gm/dl (10.0 g/L) by serum protein electrophoresis
- Urine M-protein excretion > 200 mg/24 (0.2 g/24h) hours, by urine protein electrophoresis
- Abnormal serum free light chain ratio with elevated Kappa or Lambda light chains in serum
- Baseline measurements must be done within 21 days of study entry.
- Karnofsky Performance Status Scale > 60.
- Greater than or equal to 18 years of age.
- Expected survival of greater than 8 weeks.
- Swallow intact study medication tablets.
- Can follow directions or has a caregiver who will be responsible for administering study medication.
Exclusion Criteria:
- Previously treated with R115777 (Zarnestra).
- Undergone an allogeneic bone marrow transplant.
- A platelet count of <100,000 x 10 to the 9 power/L within 14 days before enrollment.
- Absolute neutrophil count of <1.0 x 10 to the 9 power/L within 14 days before enrollment.
- Measured creatinine > 1.5 X the upper limits of normal within 14 days before enrollment.
- Greater than or equal to Grade 2 peripheral neuropathy within 14 days before enrollment.
- Hypersensitivity to bortezomib, boron, mannitol or imidazole compounds
- Female subject is pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin (beta-hCG) pregnancy test result obtained during screening.
- Received other investigational drugs within 14 days of enrollment or immunotherapy within 30 days of enrollment.
- Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- Ongoing radiation therapy or radiation therapy within 14 days prior to first treatment.
- Cytotoxic chemotherapy within 30 days prior to first treatment.
- Therapy with high-dose corticosteroids within 14 days prior to first treatment.
Presence of any of the following excludes a patient from entering the study until such condition is resolved (determined within 14 days prior to the first treatment):
- Elevated total bilirubin > 2mg/dl, or direct bilirubin > 2 times the ULN.
- Serum glutamic oxaloacetic transaminase (AST, formerly SGOT) or serum glutamic pyruvic transaminase (ALT, formerly SGPT) > 2 times the ULN
- Serum calcium > 12 mg/dL.
- Concurrent serious infection.
- Life-threatening illness (unrelated to tumor).
- History of any other ACTIVE and INVASIVE cancer other than the present condition (except non-melanoma skin cancer), unless in complete remission and off of all therapy for that disease for a minimum of 3 years.
Prohibited/allowable medications or precautions:
- Enzyme-inducing anti-epileptic medications (e.g. phenytoin, phenobarbital, carbamazepine) are not allowed.
- Non-enzyme anti-epileptic medications will be allowed.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Fase I
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Phase I and II: 1.3mg/m2 iv days 1,4,8,11
Otros nombres:
Phase I: 100mg po BID days 1014 for Cohort 1, 200mg po BID days 1014 for Cohort 2, 300mg po BID days 1014 for Cohort 3. Phase II: Maximum Tolerated Dose (MTD)
Otros nombres:
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Experimental: Phase II
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Phase I and II: 1.3mg/m2 iv days 1,4,8,11
Otros nombres:
Phase I: 100mg po BID days 1014 for Cohort 1, 200mg po BID days 1014 for Cohort 2, 300mg po BID days 1014 for Cohort 3. Phase II: Maximum Tolerated Dose (MTD)
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Dose Limiting Toxicity (DLT)
Periodo de tiempo: Average of 6 months
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Determine the dose limiting toxicity at 3 weeks post treatment
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Average of 6 months
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Maximum Tolerated Dose
Periodo de tiempo: Average of 6 months
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Determine the maximum tolerated dose
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Average of 6 months
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Response Rates
Periodo de tiempo: Average of 6 months
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Determine response rates after 8 cycles of treatment
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Average of 6 months
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Toxicity
Periodo de tiempo: Average of 6 months
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Determine toxicity profiles
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Average of 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Progression Free Survival
Periodo de tiempo: Average of 12 months
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Determine progression free survival
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Average of 12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Melissa Alsina, M.D., H. Lee Moffitt Cancer Center and Research Institute
Publicaciones y enlaces útiles
Enlaces Útiles
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
- Enfermedades cardiovasculares
- Enfermedades Vasculares
- Enfermedades del sistema inmunológico
- Neoplasias por tipo histológico
- Neoplasias
- Trastornos linfoproliferativos
- Trastornos inmunoproliferativos
- Enfermedades hematológicas
- Trastornos hemorrágicos
- Trastornos hemostáticos
- Paraproteinemias
- Trastornos de proteínas en sangre
- Mieloma múltiple
- Neoplasias De Células Plasmáticas
- Agentes antineoplásicos
- Bortezomib
- Tipifarnib
Otros números de identificación del estudio
- MCC-13971
- 7032 (Otro identificador: CTEP)
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. .
Ensayos clínicos sobre PS-341
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Mayo ClinicNational Cancer Institute (NCI)TerminadoLeucemia | Trastornos mieloproliferativos crónicosEstados Unidos
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M.D. Anderson Cancer CenterMillennium Pharmaceuticals, Inc.TerminadoLeucemiaEstados Unidos
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Jules Bordet InstituteTerminadoCarcinoma de mama estadio IVBélgica
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M.D. Anderson Cancer CenterMillennium Pharmaceuticals, Inc.TerminadoCáncer de ovarios | Cáncer de trompa de Falopio | Cáncer peritoneal primarioEstados Unidos
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Rasim GucalpMillennium Pharmaceuticals, Inc.TerminadoCáncer de pulmón de células no pequeñasEstados Unidos
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M.D. Anderson Cancer CenterTerminadoMieloma múltipleEstados Unidos
-
Beijing Chao Yang HospitalInscripción por invitaciónMieloma múltiple | BortezomibPorcelana
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Sidney Kimmel Cancer Center at Thomas Jefferson...TerminadoEnfermedad de injerto contra huéspedEstados Unidos
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University of ChicagoNational Cancer Institute (NCI)Terminado
-
M.D. Anderson Cancer CenterMillennium Pharmaceuticals, Inc.TerminadoLinfoma de células BEstados Unidos