WARNING
It is recommended that DTIC-Dome (dacarbazine) be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.
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Hemopoietic depression is the most common toxicity with DTIC-Dome (See Warnings).
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Hepatic necrosis has been reported (See Warnings).
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Studies have demonstrated this agent to have a carcinogenic and teratogenic effect when used in animals.
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In treatment of each patient, the physician must weigh carefully the possibility of achieving therapeutic benefit against the risk of toxicity.
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DTIC-DOME SUMMARY
DTIC-Dome Sterile (dacarbazine) is a colorless to an ivory colored solid which is light sensitive. Each vial contains 100 mg of dacarbazine, or 200 mg of dacarbazine (the active ingredient), anhydrous citric acid and mannitol. DTIC-Dome is reconstituted and administered intravenously (pH 3-4). DTIC-Dome is an anticancer agent.
DTIC-Dome is indicated in the treatment of metastatic malignant melanoma. In addition, DTIC-Dome is also indicated for Hodgkin's disease as a secondary-line therapy when used in combination with other effective agents.
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NEWS HIGHLIGHTS
Published Studies Related to Dtic-Dome (Dacarbazine)
Dacarbazine with or without oblimersen (a Bcl-2 antisense oligonucleotide) in
chemotherapy-naive patients with advanced melanoma and low-normal serum lactate
dehydrogenase: 'The AGENDA trial'. [2014] In a previous large randomized, open-label study, retrospective subset analysis
revealed that the addition of the Bcl-2 antisense oligonucleotide oblimersen to
dacarbazine (Dac) significantly improved overall survival, progression-free
survival, and the response rate in chemotherapy-naive patients with advanced
melanoma and normal baseline serum lactate dehydrogenase (LDH) levels...
Q-TWiST analysis comparing ipilimumab/dacarbazine vs placebo/dacarbazine for
patients with stage III/IV melanoma. [2013] in this trial... CONCLUSION: During the first year of study, there was little difference between
Selumetinib plus dacarbazine versus placebo plus dacarbazine as first-line
treatment for BRAF-mutant metastatic melanoma: a phase 2 double-blind randomised
study. [2013] dacarbazine with dacarbazine alone... INTERPRETATION: Selumetinib plus dacarbazine showed clinical activity in patients
A randomised, phase II study of intetumumab, an anti-alphav-integrin mAb, alone and with dacarbazine in stage IV melanoma. [2011.07.26] BACKGROUND: alpha(v) integrins are involved in angiogenesis and melanoma tumourigenesis. Intetumumab (CNTO 95) is a fully human anti-alpha(v)-integrin monoclonal antibody... CONCLUSION: With its favourable safety profile and a nonsignificant trend towards improved OS, intetumumab merits further investigation in advanced melanoma.
Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. [2011.06.30] BACKGROUND: Ipilimumab monotherapy (at a dose of 3 mg per kilogram of body weight), as compared with glycoprotein 100, improved overall survival in a phase 3 study involving patients with previously treated metastatic melanoma. We conducted a phase 3 study of ipilimumab (10 mg per kilogram) plus dacarbazine in patients with previously untreated metastatic melanoma... CONCLUSIONS: Ipilimumab (at a dose of 10 mg per kilogram) in combination with dacarbazine, as compared with dacarbazine plus placebo, improved overall survival in patients with previously untreated metastatic melanoma. The types of adverse events were consistent with those seen in prior studies of ipilimumab; however, the rates of elevated liver-function values were higher and the rates of gastrointestinal events were lower than expected on the basis of prior studies. (Funded by Bristol-Myers Squibb; ClinicalTrials.gov number, NCT00324155.).
Clinical Trials Related to Dtic-Dome (Dacarbazine)
Study of a-Interferon With Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD) With Hodgkin's Disease [Completed]
This is a clinical research study of interferon (IFN) plus chemotherapy with the standard
combination of Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD). The treatment will be
given to patients with Hodgkin's disease. The study will look at whether adding IFN to ABVD
improves the immune response against Hodgkin's disease, and will determine whether the
toxicity of ABVD is increased by adding IFN.
Rituximab and ABVD for Hodgkin's Patients [Completed]
Primary Objective:
- To determine the feasibility, toxicity, and efficacy of Rituximab with standard dose ABVD
combination chemotherapy.
ABVD combination chemotherapy consists of Adriamycin, Bleomycin, Vinblastine and DTIC.
Prophylactic Use of Filgrastim SD/01 in Patients With Hodgkin's Disease Receiving ABVD Chemotherapy [Completed]
Prophylactic use of Filgrastim SD/01 for patients with Hodgkin's lymphoma receiving ABVD
chemotherapy.
Imatinib in Combination With Dacarbazine and Capecitabine in Medullary Thyroid Carcinoma [Terminated]
Objectives:
Primary objectives:
To determine the maximum tolerated doses (MTD) for the combination of imatinib mesylate,
capecitabine, and dacarbazine in patients with solid tumors.
To determine the overall tumor response rate to imatinib mesylate in combination with
capecitabine and dacarbazine as first line and second line therapy in advanced metastatic
medullary thyroid carcinoma.
To determine the tolerability (toxicity) of this regimen.
Secondary objectives:
To determine the median overall survival (OS) and time to progression (TTP) for patients
treated with this combination.
Phase II R-ABVD Versus ABVD for Advanced Stage Classical Hodgkin Lymphoma [Active, not recruiting]
The goal of this clinical research study is to compare the effectiveness of receiving
Adriamycin (doxorubicin hydrochloride), bleomycin, vinblastine, and dacarbazine (ABVD)
therapy alone to receiving ABVD with rituximab.
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Page last updated: 2015-08-10
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