WARNINGS
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).
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CEENU SUMMARY
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.
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NEWS HIGHLIGHTS
Published Studies Related to Ceenu (Lomustine / Lomustine / Lomustine)
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.
Randomized trial of dacarbazine versus bleomycin, vincristine, lomustine and dacarbazine (BOLD) chemotherapy combined with natural or recombinant interferon-alpha in patients with advanced melanoma. [2005.08]
This randomized phase II study was designed to compare the efficacy and tolerability of dacarbazine (DTIC) and bleomycin, vincristine, lomustine and DTIC (BOLD) combined with natural interferon-alpha (nIFN-alpha) or recombinant interferon-alpha2b (rIFN-alpha2b) in patients with advanced melanoma.Patients with soft tissue or lung metastases may achieve more complete responses with BOLD regimens.
Phase III randomized study of radiotherapy plus procarbazine, lomustine, and vincristine with or without BUdR for treatment of anaplastic astrocytoma: final report of RTOG 9404. [2004.03.15]
CONCLUSION: No survival advantage was noted by adding BUdR to EBRT and PCV in this patient population
Lomustine and melphalan cannot be replaced by cyclophosphamide and etoposide without reducing efficacy in MOPPEBVCAD chemotherapy for advanced Hodgkin's disease. [2000.07]
BACKGROUND AND OBJECTIVES: To evaluate the feasibility, toxicity and preliminary results of a potentially less toxic variant of the MOPPEBVCAD chemotherapy regimen for advanced Hodgkin's disease: MOPPEBVCyED, in which cyclophosphamide and etoposide replace lomustine and melphalan, respectively, with the remaining components being unaltered... CONCLUSIONS: The higher cumulative and single drug DI recorded with MOPPEBVCyED may reflect better short-term tolerability, but it does not lead to better disease control. Its late toxicity may be expected to be lower in the future but at present it does not seem to be a sufficient reason to substitute MOPPEBVCyED for MOPPEBVCAD.
Clinical Trials Related to Ceenu (Lomustine / Lomustine / Lomustine)
Study of IV Edotecarin Vs Temozolomide or Carmustine (BCNU) or Lomustine (CCNU) in Patients With Glioblastoma Multiforme [Completed]
The purpose of this clinical trial is to study Edotecarin in patients with the brain tumor
glioblastoma multiforme (GBM) who have progression or first recurrence following initial
treatment with surgery, radiation and chemotherapy.
Lomustine and Intermediate Dose Cytarabine in Older Patients With AML [Completed]
A multicenter randomized trial was performed comparing induction therapy (IC: Idarubicin and
Cytarabine, 5+7) to ICL (the same drugs plus lomustine (CCNU), 200mg\m2 orally at day 1).
Patients in complete remission (CR) were then randomized to receive either maintenance
therapy or intensification with intermediate-dose cytarabine and idarubicin followed by
maintenance therapy.
Phase III: Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma. [Recruiting]
The purpose of this study is to see how effective cediranib is in treating a brain tumour
called recurrent glioblastoma. Two drugs are being tested in this study. Lomustine is an
approved oral chemotherapy that belongs to the class of drugs called alkylating agents.
Cediranib is a new drug that has not yet been approved for this disease. This study will
compare the use of lomustine with cediranib, cediranib alone or lomustine with placebo
("inactive substance") to see whether the combination or cediranib alone will be more
effective than the chemotherapy alone (lomustine) in preventing the growth of cancer cells.
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, CeeNU) that can be given with temozolomide (Temodar) and thalidomide (Thalomid) in
the treatment of metastatic melanoma that has spread to the brain. The safety and
effectiveness of this combination therapy will also be studied.
Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour [Recruiting]
This is a Phase I, open-label, multi-centre study designed to assess the safety and
tolerability of Cediranib in combination with lomustine in patients with primary recurrent
malignant brain tumour.
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Page last updated: 2008-01-01
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