BOXED WARNING
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).
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BICNU SUMMARY
BiCNU® (carmustine for injection) is one of the nitrosoureas used in the treatment of certain neoplastic diseases.
BiCNU (carmustine for injection) 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.
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NEWS HIGHLIGHTSMedia Articles Related to Bicnu (Carmustine)
Adding Drug to Standard Care May Prolong Lymphoma Survival
Source: MedicineNet Cancer Specialty [2017.09.28]
Title: Adding Drug to Standard Care May Prolong Lymphoma Survival
Category: Health News
Created: 9/27/2017 12:00:00 AM
Last Editorial Review: 9/28/2017 12:00:00 AM
Aliqopa Approved for Follicular Lymphoma
Source: MedicineNet Non-Hodgkins Lymphomas Specialty [2017.09.15]
Title: Aliqopa Approved for Follicular Lymphoma
Category: Health News
Created: 9/14/2017 12:00:00 AM
Last Editorial Review: 9/15/2017 12:00:00 AM
Mantle Cell Lymphoma (MCL)
Source: MedicineNet Non-Hodgkins Lymphomas Specialty [2017.05.25]
Title: Mantle Cell Lymphoma (MCL)
Category: Diseases and Conditions
Created: 5/25/2017 12:00:00 AM
Last Editorial Review: 5/25/2017 12:00:00 AM
Non-Hodgkin's Lymphoma
Source: MedicineNet Biological Therapy Specialty [2017.03.03]
Title: Non-Hodgkin's Lymphoma
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 3/3/2017 12:00:00 AM
Published Studies Related to Bicnu (Carmustine)
The treatment of multiple myeloma using vincristine, carmustine, melphalan, cyclophosphamide, and prednisone (VBMCP) alternating with high-dose cyclophosphamide and alpha(2)beta interferon versus VBMCP: results of a phase III Eastern Cooperative Oncology Group Study E5A93. [2009.05.15]
BACKGROUND: A randomized controlled trial tested the hypothesis that aggressive initial therapy using high-dose cyclophosphamide (HiCy) and alpha(2)beta interferon (IFN) may be superior to standard combination alkylating agent regimens in the treatment of newly diagnosed myeloma... CONCLUSIONS: The study showed no significant benefit with the addition of HiCy and IFN to VBMCP.
Randomized phase II trial of erlotinib versus temozolomide or carmustine in recurrent glioblastoma: EORTC brain tumor group study 26034. [2009.03.10]
PURPOSE: Approximately 50% of glioblastomas (GBMs) are characterized by overexpression of the epidermal growth factor receptor (EGFR) and EGFR gene amplification. In approximately 25% of instances, constitutively activated EGFR mutants are present. These observations make EGFR-inhibiting drugs a logical approach for trials in recurrent GBM... CONCLUSION: Erlotinib has insufficient single-agent activity in unselected GBM. No clear biomarker associated with improved outcome to erlotinib was identified.
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]
PURPOSE: In patients with newly diagnosed glioblastoma multiforme, to determine whether cisplatin plus carmustine (BCNU) administered before and concurrently with radiation therapy (RT) improves survival compared with BCNU and RT and whether survival using accelerated RT (ART) is equivalent to survival using standard RT (SRT)... CONCLUSION: Cisplatin administered concurrently with BCNU and RT resulted in more toxicity but provided no significant improvement in survival. SRT and ART produced similar toxicity and survival.
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]
Autologous stem cell transplantation (SCT) with high-dose melphalan (HDM, 200 mg/m2) is the most effective therapy for multiple myeloma. To determine the feasibility of combining carmustine (300 mg/m2) with HDM, we enrolled 49 patients with previously treated Durie-Salmon stage II/III myeloma (32M/17W, median age 53) on a phase I/II trial involving escalating doses of melphalan (160, 180, 200 mg/m2)...
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]
CONCLUSIONS: Stereotactic radiosurgery followed by EBRT and BCNU does not improve the outcome in patients with GBM nor does it change the general quality of life or cognitive functioning.
Clinical Trials Related to Bicnu (Carmustine)
Gliadel Wafer and Fluorescence-Guided Surgery With 5-ALA Followed by Radiation Therapy And Temozolomide in Treating Patients With Primary Glioblastoma [Active, not recruiting]
RATIONALE: Drugs used in chemotherapy, such as Gliadel wafer and temozolomide, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving
radiation therapy and temozolomide after surgery and Gliadel wafer may kill any tumor cells
that remain after surgery.
PURPOSE: This phase II trial is studying the side effects of fluorescence-guided surgery
with 5-ALA given together with Gliadel wafer, followed by radiation therapy and
temozolomide, in treating patients with primary glioblastoma.
Gliadel, XRT, Temodar, Avastin Followed by Avastin, Temodar for Newly Diagnosed Glioblastoma Multiforme (GBM) [Active, not recruiting]
The purpose of this study is to determine the safety and effectiveness of Gliadel wafers at
the time of surgery, followed by the combination of radiation, Temodar, and Avastin, and
then the combination of Avastin and Temodar, after radiation is complete, on malignant brain
tumors.
About six weeks after surgery, subjects will begin standard radiation therapy, a fixed dose
of Avastin every 2 weeks, and daily Temodar for the six and a half weeks of radiation.
Beginning 2-3 weeks after the last radiation therapy, subjects will be given the same fixed
dose of Avastin intravenously (through the vein) every 14 days. They will also be given a
higher dose of oral Temodar to take daily the first 5 days of each 28-day study cycle.
O6-Benzylguanine and Topical Carmustine in Treating Patients With Early-Stage IA-IIA Cutaneous T-Cell Lymphoma [Active, not recruiting]
This phase I/II trial studies the side effects and best dose of carmustine when given
together with O6-benzylguanine and to see how well they work in treating patients with stage
IA-IIA cutaneous T-cell lymphoma. Drugs used in chemotherapy, such as carmustine, work in
different ways to stop the growth of cancer cells, either by killing the cells or by
stopping them from dividing. O6-benzylguanine may help carmustine work better by making
cancer cells more sensitive to the drug. Giving O6-benzylguanine with carmustine may kill
more cancer cells.
O6-benzylguanine and Carmustine in Treating Patients With Stage IA-IIA Cutaneous T-cell Lymphoma [Terminated]
This phase I trial is studying the side effects and best dose of carmustine given together
with O(6)-benzylguanine in treating patients with stage I or stage II cutaneous T-cell
lymphoma that has not responded to previous treatment. Drugs used in chemotherapy use
different ways to stop cancer cells from dividing so they stop growing or die. Combining
more than one drug may kill more cancer cells
A Study of Gliadel Followed by Avastin + Irinotecan for Glioblastoma Multiforme (GBM) [Terminated]
The primary objective of the study is to use 24 week survival to assess the efficacy of the
combination of Gliadel followed by Avastin and irinotecan in the treatment of grade IV
malignant glioma patients following surgical resection. The secondary objectives are to
determine the progression-free survival following the combination of Gliadel followed by
Avastin and irinotecan and to describe the toxicity of Gliadel followed by Avastin and
irinotecan.
Reports of Suspected Bicnu (Carmustine) Side Effects
Incorrect Storage of Drug (6),
Acute Pulmonary Oedema (4),
Streptococcal Bacteraemia (3),
Myelodysplastic Syndrome (3),
Erythema (3),
Dyspnoea (3),
Lymphopenia (3),
Acute Myeloid Leukaemia (3),
Ejection Fraction Decreased (3),
Necrotising Fasciitis (3), more >>
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Page last updated: 2017-09-28
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