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WARNING
Caution – This preparation should be administered by individuals experienced in the administration of vinblastine sulfate. It is extremely important that the intravenous needle or catheter be properly positioned before any vinblastine sulfate is injected. Leakage into surrounding tissue during intravenous administration of vinblastine sulfate may cause considerable irritation. If extravasation occurs, the injection should be discontinued immediately, and any remaining portion of the dose should then be introduced into another vein. Local injection of hyaluronidase and the application of moderate heat to the area of leakage help disperse the drug and are thought to minimize discomfort and the possibility of cellulitis.
FATAL IF GIVEN INTRATHECALLY. FOR INTRAVENOUS USE ONLY.
See WARNINGS for the treatment of patients given intrathecal vinblastine.
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VINBLASTINE SUMMARY
VinBLAStine Sulfate for Injection USP
Vinblastine Sulfate for Injection USP is vincaleukoblastine, sulfate (1:1) (salt). It is the salt of an alkaloid extracted from Vinca rosea Linn., a common flowering herb known as the periwinkle (more properly known as Catharanthus roseus G. Don). Previously, the generic name was vincaleukoblastine, abbreviated VLB. It is a stathmokinetic oncolytic agent. When treated in vitro with this preparation, growing cells are arrested in metaphase.
Vinblastine sulfate is indicated in the palliative treatment of the following:
- Frequently Responsive Malignancies:
- Generalized Hodgkin’s disease (Stages III and IV, Ann Arbor modification of Rye staging system)
- Lymphocytic lymphoma (nodular and diffuse, poorly and well differentiated)
- Histiocytic lymphoma
- Mycosis fungoides (advanced stages)
- Advanced carcinoma of the testis
- Kaposi’s sarcoma
- Letterer-Siwe disease (histiocytosis X)
Less Frequently Responsive Malignancies: - Choriocarcinoma resistant to other chemotherapeutic agents
Carcinoma of the breast, unresponsive to appropriate endocrine surgery and hormonal therapy
Current principles of chemotherapy for many types of cancer include the concurrent administration of several antineoplastic agents. For enhanced therapeutic effect without additive toxicity, agents with different dose-limiting clinical toxicities and different mechanisms of action are generally selected. Therefore, although vinblastine sulfate is effective as a single agent in the aforementioned indications, it is usually administered in combination with other antineoplastic drugs. Such combination therapy produces a greater percentage of response than does a single-agent regimen. These principles have been applied, for example, in the chemotherapy of Hodgkin’s disease.
Hodgkin’s Disease
Vinblastine sulfate has been shown to be one of the most effective single agents for the treatment of Hodgkin’s disease. Advanced Hodgkin’s disease has also been successfully treated with several multiple-drug regimens that included vinblastine sulfate. Patients who had relapses after treatment with the MOPP program– mechlorethamine hydrochloride (nitrogen mustard), vincristine sulfate, prednisone, and procarbazine–have likewise responded to combination-drug therapy that included vinblastine sulfate. A protocol using cyclophosphamide in place of nitrogen mustard and vinblastine sulfate instead of vincristine sulfate is an alternative therapy for previously untreated patients with advanced Hodgkin’s disease.
Advanced testicular germinal-cell cancers (embryonal carcinoma, teratocarcinoma, and choriocarcinoma) are sensitive to vinblastine sulfate alone, but better clinical results are achieved when vinblastine sulfate is administered concomitantly with other antineoplastic agents. The effect of bleomycin is significantly enhanced if vinblastine sulfate is administered 6 to 8 hours prior to the administration of bleomycin; this schedule permits more cells to be arrested during metaphase, the stage of the cell cycle in which bleomycin is active.
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NEWS HIGHLIGHTS
Published Studies Related to Vinblastine
Early versus late intensification for patients with high-risk Hodgkin lymphoma-3 cycles of intensive chemotherapy plus low-dose lymph node radiation therapy versus 4 cycles of combined doxorubicin, bleomycin, vinblastine, and dacarbazine plus myeloablative chemotherapy with autologous stem cell transplantation: five-year results of a randomized trial on behalf of the GOELAMS Group. [2008.12.15]
BACKGROUND: The 5-year freedom from treatment failure (FFTF) rate, with treatment failure defined as the lack of post-treatment complete remission (CR), recurrence, or death, ranges from 60% to 70% after 6 to 8 cycles of combined doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD), which is the reference treatment for patients with advanced Hodgkin lymphoma (HL). In this randomized, phase 2 study, the authors tested 2 intensive chemotherapy regimens in 158 patients with clinical stage (CS) IIB through IV HL accompanied by high-risk factors who were recruited between May 1997 and December 2004... CONCLUSIONS: Early intensification (Arm V) and late intensification (Arm A) were equally effective for treating patients with high-risk/advanced HL.
Phase III trial comparing concurrent biochemotherapy with cisplatin, vinblastine, dacarbazine, interleukin-2, and interferon alfa-2b with cisplatin, vinblastine, and dacarbazine alone in patients with metastatic malignant melanoma (E3695): a trial coordinated by the Eastern Cooperative Oncology Group. [2008.12.10]
PURPOSE: Phase II trials with biochemotherapy (BCT) have shown encouraging response rates in metastatic melanoma, and meta-analyses and one phase III trial have suggested a survival benefit. In an effort to determine the relative efficacy of BCT compared with chemotherapy alone, a phase III trial was performed within the United States Intergroup... CONCLUSION: Although BCT produced slightly higher response rates and longer median progression-free survival than CVD alone, this was not associated with either improved overall survival or durable responses. Considering the extra toxicity and complexity, this concurrent BCT regimen cannot be recommended for patients with metastatic melanoma.
Randomized trial comparing bleomycin/etoposide/cisplatin with alternating cisplatin/cyclophosphamide/doxorubicin and vinblastine/bleomycin regimens of chemotherapy for patients with intermediate- and poor-risk metastatic nonseminomatous germ cell tumors: Genito-Urinary Group of the French Federation of Cancer Centers Trial T93MP. [2008.01.20]
PURPOSE: Two chemotherapy regimens for intermediate- and poor-risk metastatic nonseminomatous germ cell tumors were compared for efficacy and toxicity... CONCLUSION: Because of equivalent efficacy and lesser toxicity, the standard treatment for patients with intermediate- and poor-risk metastatic nonseminomatous germ cell tumors remains four cycles of BEP.
Two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine plus extended-field radiotherapy is superior to radiotherapy alone in early favorable Hodgkin's lymphoma: final results of the GHSG HD7 trial. [2007.08.10]
PURPOSE: To investigate whether combined-modality treatment (CMT) with two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by extended-field radiotherapy (EF-RT) is superior to EF-RT alone in patients with early favorable Hodgkin's lymphoma (HL)... CONCLUSION: CMT consisting of two cycles of ABVD plus EF-RT is more effective than EF-RT alone.
A phase III trial of docetaxel/carboplatin versus mitomycin C/ifosfamide/cisplatin (MIC) or mitomycin C/vinblastine/cisplatin (MVP) in patients with advanced non-small-cell lung cancer: a randomised multicentre trial of the British Thoracic Oncology Group (BTOG1). [2006.07]
BACKGROUND: Phase III studies suggest that non-small-cell lung cancer (NSCLC) patients treated with cisplatin-docetaxel may have higher response rates and better survival compared with other platinum-based regimens. We report the final results of a randomised phase III study of docetaxel and carboplatin versus MIC or MVP in patients with advanced NSCLC... CONCLUSIONS: The combination of DCb had similar efficacy to MIC/MVP but quality of life was better maintained.
Clinical Trials Related to Vinblastine
Weekly Vinblastine for Chemotherapy Naive Children With Progressive Low Grade Glioma (PLGGs) [Recruiting]
The overall objective of this study is to determine the efficacy of weekly Vinblastine in
chemotherapy naïve patients with progressive or incompletely resected paediatric low grade
glioma, to generate estimates of the response rate, progression-free survival, toxicity and
quality of daily living among the population treated and determine biologic factors which
will enable us to predict tumour behaviour.
Vinblastine and Methotrexate in Children With Pulmonary Vein Stenosis [Recruiting]
To evaluate the efficacy of the chemotherapeutic agents vinblastine and methotrexate in the
treatment of two groups of children with multivessel pulmonary vein stenosis. Group 1 will
contain children with multivessel pulmonary vein stenosis who do not have structural heart
disease, and Group 2 will consist of children with multivessel pulmonary vein stenosis and
concomitant structural heart disease.
The primary outcome variable for efficacy is patient status one year after the start of
treatment, where status is classified as either failure or success. Failure is defined as
death or evidence of progressive obstruction at any time over the course of treatment as
defined in the protocol. Success constitutes complete or partial response to treatment or
stability of disease. Secondary outcome variables for efficacy are survival, time from
diagnosis of pulmonary vein stenosis until failure, and change in patient classification on a
scale measuring the severity of the obstructive disease.
1. 2 To assess the safety of vinblastine and methotrexate in the treatment of multivessel
pulmonary vein stenosis.
The primary outcome variable for safety is any occurrence of toxicity related to the
administration of the chemotherapeutic agents over the treatment period.
Vinblastine and Carboplatin in Treating Young Patients With Newly Diagnosed or Recurrent Low-Grade Glioma [Recruiting]
RATIONALE: Drugs used in chemotherapy, such as vinblastine and carboplatin, 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 I trial is studying the side effects and best dose of vinblastine when
given together with carboplatin in treating young patients with newly diagnosed or recurrent
low-grade glioma.
Genetic Variates of Response to Cisplatin, Vinblastine, and Temozolomide (CVT) in Patients With Metastatic Melanoma [Recruiting]
The investigators want to learn to predict which tumors will respond to CVT chemotherapy.
CVT is a combination of three drugs - cisplatin, vinblastine, and temozolomide. We and other
investigators have used CVT in melanoma patients and found that tumors got significantly
smaller in 30-40% of cases. In this study, the investigators want to get a precise idea of
how many patients will respond to CVT. Also they want to test which genes in the tumor are
turned on and which are turned off. We hope this will teach us to know in the future which
tumors will respond to CVT.
Methotrexate, Vinblastine, Doxorubicin and Cisplatin (MVAC) Followed by Gemcitabine Plus Cisplatin (GEM+CDDP) in Locally Advanced or Metastatic Bladder Cancer [Recruiting]
This phase II trial will study the effectiveness and toxicity of sequential high dose MVAC
followed by gemcitabine and cisplatin, as first line treatment in patients with locally
advanced or metastatic bladder cancer.
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Page last updated: 2009-02-07
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