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).
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NEWS HIGHLIGHTSMedia Articles Related to Bicnu (Carmustine)
Co-Founder Of Microsoft Diagnosed With Non-Hodgkin's Lymphoma
Source: Lymphoma / Leukemia / Myeloma News From Medical News Today [2009.11.17]
Paul Allen who co-founded the computer giant Microsoft with Bill Gates in the 1970s has been diagnosed with Non-Hodgkin's Lymphoma, 25 years after surviving Hodgkin's lymphoma. The news was announced in a memo to the staff of Allen's company Vulcan, by CEO Jody Allen, who is also Paul Allen's sister. A copy of the memo was also sent to the media.
FDA Approves New Drug For Rare Cancer Cutaneous T-Cell Lymphoma
Source: Blood / Hematology News From Medical News Today [2009.11.12]
The US Food and Drug Administration (FDA) has approved a new drug for treating patients with the rare white blood cell cancer Cutaneous T-cell Lymphoma (CTCL); the drug Istodax (romidepsin) is injectable and is marketed by Gloucester Pharmaceuticals Inc of Cambridge, Massachusetts. Every year, about 1,500 Americans are newly diagnosed with CTCL, a type of non-Hodgkin's lymphoma.
Istodax Approved for Cutaneous T-Cell Lymphoma
Source: MedicineNet Non-Hodgkins Lymphomas Specialty [2009.11.09]
Title: Istodax Approved for Cutaneous T-Cell Lymphoma
Category: Health News
Created: 11/6/2009 4:10:00 PM
Last Editorial Review: 11/9/2009
FDA Approves Gloucester Pharmaceuticals' ISTODAX(R) For Patients With Cutaneous T-cell Lymphoma
Source: Blood / Hematology News From Medical News Today [2009.11.06]
Gloucester Pharmaceuticals announced today that the U.S. Food and Drug Administration (FDA) approved ISTODAX® (romidepsin) for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. The approval of ISTODAX was based on objective disease response defined as the proportion of patients with confirmed complete response or partial response.
Approved Lymphoma Drug Shows Promise In Early Tests Against Bone Cancer
Source: Bones / Orthopaedics News From Medical News Today [2009.11.06]
A drug already approved for the treatment of lymphoma may also slow the growth of the most deadly bone cancer in children and teens, according to an early-stage study published online in the International Journal of Cancer. The study drug, Bortezomib, was found to be effective against bone cancer in human cancer cell studies and in mice.
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)
The PRECISE Trial: Study of IL13-PE38QQR Compared to GLIADEL Wafer in Patients With Recurrent Glioblastoma Multiforme [Active, not recruiting]
The purpose of the PRECISE trial is to determine whether overall survival duration, safety, and quality of life are improved for patients treated with IL13-PE38QQR compared to patients treated with GLIADELŪ Wafer following surgical tumor removal in the treatment of first recurrence of glioblastoma multiforme.
Gliadel Wafer and O6-Benzylguanine in Treating Patients With Recurrent Glioblastoma Multiforme [Recruiting]
RATIONALE: Drugs used in chemotherapy, such as Gliadel wafer and O6-benzylguanine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving Gliadel wafer together with O6-benzylguanine works in treating patients with recurrent glioblastoma multiforme.
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]
Subjects with newly diagnosed brain tumors who undergo surgical resection and whose pathology
in the operating room shows a high grade glioma will be eligible.
During a screening visit, the study will be discussed, inform consent discussed and signed, a
medical history will be taken and a physical examination and laboratory tests will be
performed. If these tests are all within acceptable ranges, the subject will be considered
for inclusion on this treatment protocol. If the results of any tests are extremely different
from normal expected values, she/he may not be able to participate.
Prior to surgery, the subject will have a contrast enhanced MRI and MRS. The neurosurgeon
will attempt to remove the majority of the tumor in the operating room and will send a
portion of the specimen removed to the pathologist immediately. This is called a "frozen
section". If the pathologist believes that the tumor is a high-grade malignant brain tumor,
then the surgeon will place up to 8 dime-sized chemotherapy wafers in the tumor cavity of the
brain. The remainder of the tumor specimen will be given to the pathologist to review more
closely in the laboratory. If the frozen section does not show that the tumor is a
high-grade malignant brain tumor, the subject will not receive the Gliadel wafers and will be
removed from the study. The surgeon will then discuss with the subject the appropriate
treatment options for the disease he or she has.
During recovery in the hospital, another contrast enhanced MRI will be performed within the
first 72 hours after surgery. This is a standard of care for patients who are not involved
on this protocol as well. The subject will have another contrast enhanced MRI and MRS
performed at the 21st Day after his or her surgery. After Day 21, He or she may begin other
forms of treatment. The last contrast enhanced MRI and MRS assessment will be performed 12
weeks after the surgery and the implantation of the Gliadel wafers. Further MRI and MRS may
be performed subsequently at the discretion of the doctor.
Throughout the course of treatment, clinical data will be collected.
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.
Carmustine in Treating Adults With Recurrent Supratentorial Low-Grade Glioma [Active, not recruiting]
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of carmustine in treating adults with recurrent supratentorial low-grade glioma.
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