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Bicnu (Carmustine) - Summary

 
 



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.

See all Bicnu indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Bicnu (Carmustine)

Hodgkin lymphoma: Phase 3 AETHERA clinical trial data reported
Source: Clinical Trials / Drug Trials News From Medical News Today [2014.12.10]
Takeda UK Ltd has reported data demonstrating that Hodgkin lymphoma (HL) patients at risk of relapse following an autologous stem cell transplant (ASCT) who received ADCETRIS (brentuximab vedotin)...

Hodgkin lymphoma patients benefit from immunotherapy drugs
Source: Immune System / Vaccines News From Medical News Today [2014.12.10]
In recent years, a number of scientific breakthroughs have led to the development of drugs that unleash the power of the immune system to recognize and attack cancer.

Latest results of investigational cellular therapy in pediatric acute lymphoblastic leukemia, and first results of lymphoma trial
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2014.12.10]
The latest results of clinical trials of more than 125 patients testing an investigational personalized cellular therapy known as CTL019 was presented by a University of Pennsylvania research team at...

Cornerstone Pharmaceuticals commences Phase I clinical trial of CPI-613 for the treatment of B-cell Non-Hodgkin lymphoma
Source: Clinical Trials / Drug Trials News From Medical News Today [2014.12.09]
Cornerstone Pharmaceuticals, Inc., a clinical stage company and leader in the growing field of cancer metabolism-based therapeutics, has announced the initiation of a Phase I clinical trial...

Hodgkin lymphoma responds to immunotherapy
Source: Blood / Hematology News From Medical News Today [2014.12.08]
Two trials show promising results in Hodgkin lymphoma patients treated with immunotherapy drugs that helped their immune system recognize and attack their blood cancer.

more news >>

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.

more studies >>

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 [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) [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 [Recruiting]
This phase I/II trial is studying the side effects of giving O6-benzylguanine together with topical carmustine and to see how well it works in treating patients with stage IA or stage IIA cutaneous T-cell lymphoma that has not responded to treatment. 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

A Study of Gliadel Followed by Avastin + Irinotecan for Glioblastoma Multiforme (GBM) [Recruiting]
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.

Lymphokine-Activated Killer Cells or Gliadel Wafer in Treating Patients With Newly Diagnosed Glioblastoma Multiforme That Can Be Removed by Surgery [Recruiting]
RATIONALE: Biological therapies, such as lymphokine-activated killer cells, may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as Gliadel wafer, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether lymphokine-activated killer cells are more effective than Gliadel wafer in treating patients with glioblastoma multiforme.

PURPOSE: This randomized phase II trial is studying the side effects and how well lymphokine-activated killer cells work compared with Gliadel wafer in treating patients with newly diagnosed glioblastoma multiforme that can be removed by surgery.

more trials >>

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 >>


Page last updated: 2014-12-10

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