CeeNU(lomustine) should be administered under the supervision of a qualified physicianexperienced in the use of cancer chemotherapeutic agents.
Bonemarrow suppression, notably thrombocytopenia and leukopenia, which may contributeto bleeding and overwhelming infections in an already compromised patient,is the most common and severe of the toxic effects of CeeNU (see WARNINGS and ADVERSE REACTIONS).
Sincethe major toxicity is delayed bone marrow suppression, blood counts shouldbe monitored weekly for at least 6 weeks after a dose (see ADVERSEREACTIONS). At the recommended dosage, courses of CeeNU shouldnot be given more frequently than every 6 weeks.
Thebone marrow toxicity of CeeNU is cumulative and therefore dosage adjustmentmust be considered on the basis of nadir blood counts from prior dose (see dosage adjustment table under DOSAGEAND ADMINISTRATION).
CeeNU® (lomustine) (CCNU) is one of the nitrosoureas used in the treatment of certain neoplastic diseases. It is 1-(2-chloro-ethyl)-3-cyclohexyl-1-nitrosourea.
CeeNU (lomustine/lomustine/lomustine) is indicated for the following:
CeeNU has been shown to be useful as a single agent in addition to other treatment modalities, or in established combination therapy with other approved chemotherapeutic agents in the following:
Brain tumors —both primary and metastatic, in patients who have already received appropriate surgical and/or radiotherapeutic procedures.
Hodgkin’s Disease —secondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.
Published Studies Related to Ceenu (Lomustine / Lomustine / Lomustine)
Temozolomide versus procarbazine, lomustine, and vincristine in recurrent high-grade glioma. [2010.10.20]
PURPOSE: Temozolomide (TMZ) is an alkylating agent licensed for treatment of high-grade glioma (HGG). No prospective comparison with nitrosourea-based chemotherapy exists. We report, to our knowledge, the first randomized trial of procarbazine, lomustine, and vincristine (PCV) versus TMZ in chemotherapy-naive patients with recurrent HGG... CONCLUSION: Although TMZ (both arms combined) did not show a clear benefit compared with PCV, comparison of the TMZ schedules demonstrated that the 21-day schedule was inferior to the 5-day schedule in this setting. This challenges the current understanding of increasing TMZ dose-intensity by prolonged scheduling.
Phase III study of enzastaurin compared with lomustine in the treatment of recurrent intracranial glioblastoma. [2010.03.01]
PURPOSE: This phase III open-label study compared the efficacy and safety of enzastaurin versus lomustine in patients with recurrent glioblastoma (WHO grade 4)... CONCLUSION: Enzastaurin was well tolerated and had a better hematologic toxicity profile but did not have superior efficacy compared with lomustine in patients with recurrent glioblastoma.
NOA-04 randomized phase III trial of sequential radiochemotherapy of anaplastic glioma with procarbazine, lomustine, and vincristine or temozolomide. [2009.12.10]
PURPOSE: The standard of care for anaplastic gliomas is surgery followed by radiotherapy. The NOA-04 phase III trial compared efficacy and safety of radiotherapy followed by chemotherapy at progression with the reverse sequence in patients with newly diagnosed anaplastic gliomas... CONCLUSION: Initial radiotherapy or chemotherapy achieved comparable results in patients with anaplastic gliomas. IDH1 mutations are a novel positive prognostic factor in anaplastic gliomas, with a favorable impact stronger than that of 1p/19q codeletion or MGMT promoter methylation.
Adding lomustine to idarubicin and cytarabine for induction chemotherapy in older patients with acute myeloid leukemia: the BGMT 95 trial results. [2007.10]
BACKGROUND AND OBJECTIVES: Treatment of acute myeloid leukemia (AML) in older patients remains unsatisfactory. The BGMT 95 trial for older patients set out to improve the outcome of these patients by adding a third drug (lomustine) to a 5+7 idarubicin and cytarabine schedule at induction and evaluating intermediate-dose cytarabine as consolidation... CONCLUSIONS: Adding lomustine to induction with idarubicin and cytarabine therapy did not statistically improve survival in elderly patients with AML. Adding intermediate-dose cytarabine to consolidation therapy did not improve outcome.
Adjuvant procarbazine, lomustine, and vincristine improves progression-free survival but not overall survival in newly diagnosed anaplastic oligodendrogliomas and oligoastrocytomas: a randomized European Organisation for Research and Treatment of Cancer phase III trial. [2006.06.20]
PURPOSE: Anaplastic oligodendrogliomas are more responsive to chemotherapy than high-grade astrocytomas. We investigated, in a multicenter randomized controlled trial, whether adjuvant procarbazine, lomustine, and vincristine (PCV) chemotherapy improves overall survival (OS) in newly diagnosed patients with anaplastic oligodendrogliomas or anaplastic oligoastrocytomas... CONCLUSION: Adjuvant PCV chemotherapy does not prolong OS but does increase PFS in anaplastic oligodendroglioma. Combined loss of 1p/19q identifies a favorable subgroup of oligodendroglial tumors. No genetic subgroup could be identified that benefited with respect to OS from adjuvant PCV.
Clinical Trials Related to Ceenu (Lomustine / Lomustine / Lomustine)
Standard Dose Bevacizumab Versus Low Dose Bevacizumab Plus Lomustine (CCNU) for Recurrent Glioblastoma Multiforme (GBM) [Recruiting]
The goal of this clinical research study is to learn if the combination of bevacizumab and
lomustine can help to control glioblastoma. The safety of this combination will also be
Temozolomide, Thalidomide, and Lomustine (TTL) in Melanoma Patients [Recruiting]
The goal of this clinical research study is to find the highest safe dose of lomustine
(CCNU, CeeNUTM) that can be given with temozolomide (TemodarTM) and thalidomide (ThalomidTM)
in the treatment of metastatic melanoma that has spread to the brain. The safety and
effectiveness of this combination therapy will also be studied.
Efficacy and Safety Study of Lomustine/Temozolomide Combination Therapy vs. Standard Therapy for Glioblastoma Patients [Recruiting]
The prognosis of patients with newly diagnosed glioblastoma is dismal despite recent
therapeutic improvements Using standard therapy with temozolomide (TMZ) and radiotherapy (60
Gy), the median overall survival time (mOS) is 14. 6 months (Stupp et al., 2005). Since in a
previous non-randomized bicentric phase II trial, primary combination chemotherapy with
lomustine (CCNU) and TMZ was highly effective (mOS 23 months; UKT-03 trial; Herrlinger et
al., 2006; Glas et al., 2009) the proposed trial further investigates the efficacy of
CCNU/TMZ in a randomized multicenter phase III setting against standard therapy. In case the
projected phase III trial confirms the phase II data, CCNU/TMZ combination would be
significantly better than TMZ monotherapy and would thus be the new standard treatment for
newly diagnosed GBM patients with a methylated MGMT promotor. Thus, this trial has the
potential to profoundly change the standard therapy of this most aggressive brain tumor.
Since in the previous trial only patients with a methylated MGMT (mMGMT) promoter had a
benefit from CCNU/TMZ (mOS in the mMGMT group 34 months, in the non-mMGMT group 12. 5 months;
Glas et al., 2009) while patients with a non-methylated MGMT did not have any benefit, the
trial is restricted to mMGMT patients. The CeTeG trial randomizes in a 1: 1 fashion newly
diagnosed GBM patients (18-70 years) for either standard TMZ therapy (concomitant and 6
courses à 4 weeks of adjuvant TMZ therapy) or experimental CCNU/TMZ therapy (6 courses à 6
weeks). Both arms include standard radiotherapy (RT) of the tumor site (30 x 2 Gy). Assuming
that CCNU/TMZ therapy increases the median overall survival (mOS) from 48. 9% (standard TMZ)
to 70% (CCNU/TMZ; 75% in the previous phase II trial, Glas et al., 2009), 2 x 68 patients
have to be accrued. Patients will be accrued over 24 months and each patient will be
followed for at least 24 months adding up to a total minimal duration of the time from first
patient in until the end of the follow-up time of 48 months. The primary endpoint is overall
survival; secondary endpoints include progression-free survival, response rate, acute and
late toxicity, and quality of life.
Procarbazine and Lomustine in Recurrent Glioblastoma [Recruiting]
The combination therapy of temozolomide and radiation has been established as the standard
therapy for the initial treatment of glioblastoma. However, the prognosis for patients with
recurrent/ refractory glioblastoma is dismal, with a median survival of 3~6 months. There is
no efficient and standard care at the time of recurrence or progression following
temozolomide administration. Recently, many clinicians have reassessed the efficacy of
second-line chemotherapeutic agents such as nitrosoureas for the treatment of
recurrent/refractory glioblastoma. It is very important that the effect of the agent is
sustained and the adverse effect is reduced to preserve the quality of life in recurrent
settings. We have realized that the clinical features of Korean patients are very different
from those of foreign patients. Therefore, it is mandatory to develop the new strategy for
the treatment of Korean patients. We modify the PCV chemotherapy in the dose and
administration schedule of CCNU and procarbazine to reduce the side effect, especially
hematologic problems. The dose of CCNU is reduced to 75mg/m2 and the interval between CCNU
and procarbazine is increased. Moreover, vincristine is excluded because BBB permeability of
vincristine is very poor and the risk of neurotoxicity is high. We introduce the modified PC
chemotherapy regimen for the treatment of recurrent/refractory glioblastoma, which is the
first multicenter trial for glioblastoma patients in Korea.
Adding Lomustine to Chemotherapy in Older Patients With Acute Myelogenous Leukemia (AML), and Allogeneic Transplantation for Patients From 60 to 65 Years Old [Recruiting]
A multicenter randomized trial comparing induction therapy (IC: Idarubicin and Cytarabine, 5
+ 7) to ICL (the same drugs plus lomustine (CCNU), 200 mg/m2 orally at day 1). Patients in
complete remission (CR) will then receive a post-remission schedule with or without
lomustine according to randomization. Patients from 60 to 65 years old will be proposed to
reduced conditioning allogeneic transplantation after first consolidation.
Reports of Suspected Ceenu (Lomustine / Lomustine / Lomustine) Side Effects
Circumstance or Information Capable of Leading TO Medication Error (2),
Medication Error (1),
Retinal Exudates (1),
Platelet Count Decreased (1)
Page last updated: 2011-12-09