Bryostatin 1 Plus Cisplatin in Treating Patients With Metastatic or Unresectable Cancer
Phase I Study of Bryostatin-1 (NSC 339555) and Cisplatin in Advanced Malignancies
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 trial to study the effectiveness of bryostatin 1 plus cisplatin in treating patients who have metastatic or unresectable cancer.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of bryostatin 1 in combination with cisplatin in patients with advanced malignancy. II. Determine the recommended phase II doses of bryostatin 1 and cisplatin in both a 21 day and 14 day course, based on toxicity, effect on protein kinase C activity, and pharmacokinetics, in this patient population. III. Determine the pharmacokinetics of bryostatin 1 in these patients. IV. Identify any objective tumor responses arising from treatment in these patients.
OUTLINE: This is a dose escalation study of bryostatin 1. Cohorts 1-7: Patients receive cisplatin IV over 1 hour on day 1 of the first course. Subsequent courses repeat every 21 days with bryostatin 1 IV over 24 hours on day 1 and cisplatin IV over 1 hour on day 2 in the absence of disease progression or unacceptable toxicity. Cohorts 8-10: Patients receive cisplatin as in cohorts 1-7. Subsequent courses repeat every 21 days with bryostatin 1 IV over 1 hour followed by cisplatin on day 1. Cohort 11: Patients receive bryostatin 1 and cisplatin as in cohorts 8-10. Cohorts of 3-6 patients receive escalating doses of bryostatin 1 or cisplatin until the maximum tolerated dose (MTD) of is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience DLT. The recommended phase II dose (RPTD) is defined as the dose preceding the MTD. After the RPTD is determined for the 21 day schedule, cohorts of patients receive escalating doses of bryostatin and constant doses of cisplatin on a 14 day schedule. The MTD14 and RPTD14 are determined in the same manner as above. Patients are followed for 6 months.
PROJECTED ACCRUAL: A total of 36-72 patients will be accrued for this study.
Tipo de estudio
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
New York
-
New York, New York, Estados Unidos, 10016
- NYU School of Medicine's Kaplan Comprehensive Cancer Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
DISEASE CHARACTERISTICS: Histologically confirmed metastatic or unresectable malignant disease Prior brain metastases with no residual signs or symptoms or medications allowed
PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No concurrent condition that would preclude study No psychological, familial, sociological, or geographical condition that might compromise medical follow up No neuropathy greater than grade 1, including hearing loss
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas)and recovered Prior cisplatin allowed Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior radiotherapy Prior radiotherapy for brain metastases allowed Surgery: Not specified
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Pavlick AC, Wu J, Roberts J, Rosenthal MA, Hamilton A, Wadler S, Farrell K, Carr M, Fry D, Murgo AJ, Oratz R, Hochster H, Liebes L, Muggia F. Phase I study of bryostatin 1, a protein kinase C modulator, preceding cisplatin in patients with refractory non-hematologic tumors. Cancer Chemother Pharmacol. 2009 Sep;64(4):803-10. doi: 10.1007/s00280-009-0931-y. Epub 2009 Feb 17.
- Pavlick AC, Hamilton A, Liebes L, et al.: Bryostatin 1 and cisplatin: a phase I and pharmacodynamic study. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-328, 2001.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (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
- CDR0000065897
- NYU-9709
- NCI-T97-0058
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. .