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Bicnu (Carmustine) - Summary

 

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WARNINGS

BiCNU (carmustine for injection) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.

Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to bleeding and overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of BiCNU (see WARNINGS and ADVERSE REACTIONS).

Since the major toxicity is delayed bone marrow suppression, blood counts should be monitored weekly for at least 6 weeks after a dose (see ADVERSE REACTIONS). At the recommended dosage, courses of BiCNU should not be given more frequently than every 6 weeks.

The bone marrow toxicity of BiCNU is cumulative and therefore dosage adjustment must be considered on the basis of nadir blood counts from prior dose (see “Dosage Adjustment Table” under DOSAGE AND ADMINISTRATION).

Pulmonary toxicity from BiCNU appears to be dose related. Patients receiving greater than 1400 mg/m2 cumulative dose are at significantly higher risk than those receiving less.

Delayed pulmonary toxicity can occur years after treatment, and can result in death, particularly in patients treated in childhood (see ADVERSE REACTIONS and PRECAUTIONS: Pediatric Use).

 

BICNU SUMMARY

BiCNU®
(carmustine for injection)

BiCNU® (carmustine for injection) is one of the nitrosoureas used in the treatment of certain neoplastic diseases. It is 1,3-bis (2-chloroethyl)-1-nitrosourea.

BiCNU is indicated as palliative therapy as a single agent or in established combination therapy with other approved chemotherapeutic agents in the following:

  1. Brain tumors—glioblastoma, brainstem glioma, medulloblastoma, astrocytoma, ependymoma, and metastatic brain tumors.
  2. Multiple myeloma—in combination with prednisone.
  3. Hodgkin’s Disease—as 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.
  4. Non-Hodgkin’s lymphomas—as secondary therapy in combination with other approved drugs for patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.

BICNU NEWS HIGHLIGHTS

Media Articles Related to Bicnu (Carmustine)

VCU Massey Cancer Center Spearheads Novel Clinical Study For Lymphoma Patients
Source: Clinical Trials / Drug Trials News From Medical News Today [2008.09.03]

REVLIMID(R) Demonstrates Activity Against Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma (NHL)
Source: Blood / Hematology News From Medical News Today [2008.09.02]

Tough Journey For Families Of Children With Lymphoma
Source: Lymphoma / Leukemia News From Medical News Today [2008.08.29]

Genmab Has Announced Plans To Begin Four Studies Of Ofatumumab In Chronic Lymphocytic Leukemia And Non-Hodgkin's Lymphoma
Source: Lymphoma / Leukemia News From Medical News Today [2008.08.27]

Clinical Data Published In 'Science' Show Tumor Regressions In Relapsed Lymphoma Patients Treated With T Cell Engaging BiTE Antibody Blinatumomab
Source: Lymphoma / Leukemia News From Medical News Today [2008.08.15]

more>>

Published Studies Related to Bicnu (Carmustine)

Phase III trial of carmustine and cisplatin compared with carmustine alone and standard radiation therapy or accelerated radiation therapy in patients with glioblastoma multiforme: North Central Cancer Treatment Group 93-72-52 and Southwest Oncology Group 9503 Trials. [2006.08.20]

Results of a phase I/II trial adding carmustine (300 mg/m2) to melphalan (200 mg/m2) in multiple myeloma patients undergoing autologous stem cell transplantation. [2006.02]

Randomized comparison of stereotactic radiosurgery followed by conventional radiotherapy with carmustine to conventional radiotherapy with carmustine for patients with glioblastoma multiforme: report of Radiation Therapy Oncology Group 93-05 protocol. [2004.11.01]

The use of high-dose cyclophosphamide, carmustine, and thiotepa plus autologous hematopoietic stem cell transplantation as consolidation therapy for high-risk primary breast cancer after primary surgery or neoadjuvant chemotherapy. [2004.11]

A randomized trial of amifostine and carmustine-containing chemotherapy to assess lung-protective effects. [2004.04]

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Clinical Trials Related to Bicnu (Carmustine)

The PRECISE Trial: Study of IL13-PE38QQR Compared to GLIADEL Wafer in Patients With Recurrent Glioblastoma Multiforme [Active, not recruiting]

Gliadel Wafer and O6-Benzylguanine in Treating Patients With Recurrent Glioblastoma Multiforme [Recruiting]

Examination of Changes on Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) in Patients Who Receive Gliadel Wafers During Initial Surgery for Glioblastoma Multiforme. Response or Failure to Gliadel Wafers for Subjects With Glioblastoma Multiforme. [Recruiting]

Exploratory Study, Evaluating the Treatment Effect of Surgery Plus GLIADELŪ Wafer in Patients With Metastatic Brain Cancer [Recruiting]

Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma [Active, not recruiting]

more>>

Page last updated: 2008-09-03

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