Assessment of Tipifarnib in Relapsed Non-Hodgkin's Lymphoma
Laboratory Biomarker Analysis
+ Tipifarnib
Enfermedades hemáticas y linfáticas+16
+ Enfermedad Crónica
+ Enfermedades Hematológicas
Estudio de Tratamiento
Resumen
Fecha de inicio: 24 de marzo de 2004
Fecha en la que se inscribió al primer participante.This study focuses on evaluating a drug called R115777, also known as tipifarnib, for the treatment of relapsed non-Hodgkin's lymphoma. This includes aggressive, indolent, and uncommon types of non-Hodgkin's lymphoma. The main goal is to understand how well this drug works in shrinking tumors in patients who have not responded well to previous treatments. The study also aims to identify any potential side effects associated with this medication. The importance of this study lies in its potential to improve treatment options for patients with relapsed non-Hodgkin's lymphoma. Patients participating in this study will receive tipifarnib orally, twice a day, for the first 21 days. This cycle will repeat every 28 days unless the disease progresses or unacceptable side effects occur. After completing the treatment, patients will be followed up every six months for two years. The study measures the response to treatment by evaluating the reduction in the size of the tumors. A confirmed response is considered when there is at least a 50% decrease in the size of the largest tumors and no new sites of disease. The study also assesses any potential toxicity associated with this treatment.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 93 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: * Biopsy-proven relapsed or refractory lymphomas; previous biopsies =\< 6 months prior to treatment on this protocol will be acceptable as long as there has not been intervening therapy; if the patient has received therapy for non-Hodgkin's disease (NHL) between the time of the last biopsy and this protocol, then a re-biopsy is necessary * STUDY 1: Aggressive lymphomas (permanently closed to accrual 6/28/06): * Transformed lymphomas * Diffuse large B cell lymphoma * Mantle cell lymphoma * Follicular lymphoma grade III STUDY 2: Indolent lymphomas (permanently closed to accrual 9/26/07) * Small lymphocytic lymphoma/chronic lymphocytic leukemia * Follicular lymphoma, grades 1, 2 * Extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT) type * Nodal marginal zone B-cell lymphoma * Splenic marginal zone B-cell lymphoma STUDY 3: Uncommon lymphomas: * Peripheral T cell lymphoma, unspecified * Anaplastic large cell lymphoma (T and null cell type) * Lymphoplasmacytic lymphoma * Mycosis fungoides/ Sezary syndrome * Relapsed Hodgkin's disease (patients must be previously treated and either have had a transplant or not be eligible for a transplant) * Previously treated (no limitations on the number of prior therapies); patients with aggressive lymphoma (Study 1 - permanently closed to accrual 6/28/06) should have received or be ineligible for potentially curable therapy including stem cell transplant * MEASURABLE DISEASE: Must have at least one lesion that has a single diameter of \>= 2 cm or tumor cells in the blood \>= 5 x10\^9/L * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2 * Absolute neutrophil count \>=1000/mm\^3 * Platelet count \>= 75,000 * Hemoglobin \>= 9 g/dL * Total bilirubin =\< 2 x upper limit of normal (ULN) (if \> 2 x ULN direct bilirubin is required and should be =\< 1.5 x ULN) * Aspartate aminotransferase (AST) =\< 3 x ULN (=\< 5 x ULN if liver involvement is present) * Serum creatinine =\< 2 x ULN * Expected survival \>= 3 months * Capable of understanding the investigational nature, potential risks and benefits of the study and able to provide valid informed consent * Capable of swallowing intact study medication tablets * Capable of following directions regarding taking study medication, or has a daily caregiver who will be responsible for administering study medication Exclusion Criteria: * Any of the following as this regimen may be harmful to a developing fetus or nursing child: * Pregnant women * Breastfeeding women * Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception (condoms, diaphragm, birth control pills, injections, intrauterine device \[IUD\], surgical sterilization, subcutaneous implants, or abstinence, etc.) * NOTE: The effects of R115777 on the developing human fetus at the recommended therapeutic dose are unknown * Life-threatening illness (unrelated to tumor) * Ongoing radiation therapy or radiation therapy =\< 3 weeks prior to study registration unless the acute side effects associated with such therapy are resolved * Therapy with myelosuppressive chemotherapy, cytotoxic chemotherapy, or biologic therapy =\< 3 weeks (6 weeks for nitrosourea or mitomycin C) or corticosteroids =\< 2 weeks, prior to starting R11577; patients may be on corticosteroids or tapering off them up until the day they start R11577 as long as it is clear that they are not having a tumor response to the steroids or that the steroids would confuse the interpretation of response to R11577; patients may be receiving stable (not increased within the last month) chronic doses of corticosteroids with a maximum dose of 20 mg of prednisone per day if they are being given for disorders other than lymphoma such as rheumatoid arthritis, polymyalgia rheumatica, adrenal insufficiency, or intractable symptoms of lymphoma * Peripheral neuropathy \>= grade 3 * Serious non-malignant disease such as active infection or other condition which in the opinion of the investigator would compromise other protocol objectives * Presence of central nervous system (CNS) lymphoma * Other active malignancies * Once a patient begins FTI (tipifarnib) treatment, the addition of other cancer treatment will confound the assessment of efficacy and therefore is not allowed; this restriction precludes the addition of cytotoxic, immunologic agents, radiotherapy, or an increase in corticosteroid dose while the patient is in the treatment phase of this protocol * Known to be human immunodeficiency virus (HIV) positive; HIV testing is not required but should be done if clinically indicated; HIV patients are excluded because of concerns regarding excess risk of complications of immunosuppressive therapy regimens * Known allergy to imidazole drugs such as clotrimazole, ketoconazole, miconazole, econazole, fenticonazole, sulconazole, tioconazole, or terconazole
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene 2 ubicaciones
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, United StatesAbrir University of Iowa/Holden Comprehensive Cancer Center en Google MapsMayo Clinic
Rochester, United States